Version July 2025
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine is not approved for the treatment of patients with dementia-related psychosis.
Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients older than 24 years; there was a reduction in risk with antidepressant use in patients 65 years and older. In patients of all ages who are started on antidepressant therapy, monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Quetiapine is not approved for use in pediatric patients younger than 10 years.
Bipolar disorder, mania or episodes with mixed features: Note: Due to decreased risk of extrapyramidal symptoms, second-generation antipsychotics including quetiapine have replaced first-generation antipsychotics for treatment as monotherapy or in combination with other agents (Ref).
Children ≥10 years and Adolescents:
Immediate-release tablet: Oral: Initial: 25 mg twice daily on day 1; increase to 50 mg twice daily on day 2, then 100 mg twice daily on day 3, then 150 mg twice daily on day 4, then continue at the target dose of 200 mg twice daily beginning on day 5. May increase further based on clinical response and tolerability at increments ≤100 mg/day up to 300 mg twice daily; however, no additional benefit was seen with 300 mg twice daily versus 200 mg twice daily. Usual dosage range: 200 to 300 mg twice daily; maximum daily dose: 600 mg/day. Total daily doses may also be divided into 3 doses per day. Continue therapy at lowest dose needed to maintain remission; periodically assess maintenance treatment needs.
Extended-release tablet: Oral: Initial: 50 mg once daily on day 1; increase to 100 mg once daily on day 2, then increase in 100 mg/day increments each day until a target dose of 400 mg once daily is reached on day 5. Usual dosage range: 400 to 600 mg once daily; maximum daily dose: 600 mg/day; continue therapy at lowest dose needed to maintain remission; periodically assess maintenance treatment needs.
Switching from immediate release to extended release: May convert patients from immediate-release to extended-release tablets at the equivalent total daily dose and administer once daily; individual dosage adjustments may be necessary.
Delirium; ICU-associated: Limited data available (Ref):
Note: Data in infants is very limited; use with caution; discontinue with taper as soon as possible; pharmacokinetics, safety (QT prolongation), and long-term effects of dopamine-receptor antagonism in this population are not defined (Ref). In all pediatric patients, due to risk of QT prolongation, EKG monitoring has been reported at baseline and at 48 hours after therapy initiation; more frequent monitoring may be needed in patients with concomitant therapy that prolongs QT or additional clinical factors.
Infants >2 months, Children, and Adolescents: Immediate release: Oral: Initial: 0.5 mg/kg/dose every 8 to 12 hours; maximum reported initial daily dose: 50 mg/day in 3 divided doses (Ref); may titrate by 0.5 mg/kg/dose based on response by routine assessment with a validated screening tool (eg, Cornell Assessment of Pediatric Delirium [CAPD], pediatric Confusion Assessment Method [pCAM], preschool Confusion Assessment Method [psCAM]) up to reported maximum daily dose of 6 mg/kg/day or 200 mg/day, whichever is less (Ref).
Dosage based on small trials and case-series that reported improvement in delirium symptoms (Ref) and significant reductions in concomitant opioid and benzodiazepine dosing (Ref); however, a small trial did not show improvement in CAPD scores. Reported (if available) duration of therapy was variable (reported median range: 10 to 29 days); quetiapine should be discontinued by tapering dose; do not stop drug abruptly (Ref).
Schizophrenia: Note: Second-generation antipsychotics (including quetiapine) are generally the preferred initial treatment in management of pediatric patients with schizophrenia due to decreased risk of extrapyramidal symptoms and tardive dyskinesia (Ref).
Adolescents:
Immediate-release tablet: Oral: Initial: 25 mg twice daily on day 1; increase to 50 mg twice daily on day 2, then 100 mg twice daily on day 3, then 150 mg twice daily on day 4, then continue at a target dose of 200 mg twice daily beginning on day 5. May increase further based on clinical response and tolerability at increments ≤100 mg/day up to 400 mg twice daily; however, no additional benefit was seen with 400 mg twice daily versus 200 mg twice daily. Usual dosage range: 200 to 400 mg twice daily; maximum daily dose: 800 mg/day. Total daily doses may also be divided into 3 doses per day. Periodically assess maintenance treatment needs.
Extended-release tablet: Oral: Initial: 50 mg once daily on day 1; increase to 100 mg once daily on day 2, then increase in 100 mg/day increments each day until a target dose of 400 mg once daily is reached on day 5. Usual dosage range: 400 to 800 mg once daily; maximum daily dose: 800 mg/day. Periodically assess maintenance treatment needs.
Switching from immediate release to extended release: May convert patients from immediate-release to extended-release tablets at the equivalent total daily dose and administer once daily; individual dosage adjustments may be necessary.
Dosing conversion: To convert patients between immediate-release and extended-release tablets, administer the equivalent total daily dose. Administer immediate release 1 to 3 times daily and extended release once daily; individual dosage adjustments may be necessary.
Reinitiation of treatment: Patients who have discontinued therapy for >1 week should generally be retitrated using the initial dosing schedule; patients who have discontinued <1 week can generally be reinitiated on their previous maintenance dose.
Discontinuation of psychosis therapy: Children ≥10 years and Adolescents: The manufacturer and American Academy of Child and Adolescent Psychiatry (AACAP), American Psychiatric Association (APA), Canadian Psychiatric Association (CPA), National Institute for Health and Care Excellence (NICE), and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines recommend gradually tapering antipsychotics to avoid withdrawal symptoms and minimize the risk of relapse (Ref); risk for withdrawal symptoms may be highest with highly anticholinergic or dopaminergic antipsychotics (Ref). When stopping antipsychotic therapy in patients with schizophrenia, the CPA guidelines recommend a gradual taper over 6 to 24 months and the APA guidelines recommend reducing the dose by 10% each month (Ref). Continuing antiparkinsonism agents for a brief period after discontinuation may prevent withdrawal symptoms (Ref). When switching antipsychotics, three strategies have been suggested: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic), overlap and taper (maintaining the dose of the first antipsychotic while gradually increasing the new antipsychotic, then tapering the first antipsychotic), and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). Evidence supporting ideal switch strategies and taper rates is limited and results are conflicting (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function: Children ≥10 years and Adolescents: Oral: No dosage adjustment necessary. Note: Removal by dialysis unlikely due to relatively high protein binding and large volume of distribution.
Children ≥10 years and Adolescents:
Immediate release: Oral: Initial: 25 mg once daily; increase dose by 25 to 50 mg/day to effective dose, based on individual clinical response and tolerability.
Extended release: Oral: Initial: 50 mg once daily; increase dose by 50 mg once daily to effective dose, based on individual clinical response and tolerability.
(For additional information see "Quetiapine: Drug information")
Dosage guidance:
Safety: Dose-dependent QTc interval prolongation: Avoid use in patients with baseline QTc >450 msec or with risk factors for QTc prolongation. In patients with QTc >500 msec or QTc increase >60 msec on treatment, consider switching antipsychotics or lowering quetiapine dose (Ref). Catatonia: Antipsychotics are not indicated for use in catatonia and may worsen psychosis and increase risk for neuroleptic malignant syndrome in patients with catatonia (Ref).
Clinical considerations: Consult a psychiatry specialist for all management decisions; select antipsychotic carefully based on patient preference, clinical characteristics, history, comorbidities, and adverse effect profile (Ref).
Agitation/Aggression and psychosis associated with dementia, severe or refractory (alternative agent) (off-label use):
Note: For short-term adjunctive use while addressing underlying cause(s) of severe symptoms. In patients without a clinically significant response after an adequate trial (eg, up to 4 weeks), taper and withdraw therapy. Only continue in patients with demonstrated benefit; attempt to taper and withdraw at regular intervals (eg, within 4 months of initiation). Patients with dementia with Lewy bodies are at increased risk for severe adverse reactions; caution is required even with low doses (Ref).
Immediate release: Oral: Initial: 25 mg at bedtime; may increase dose gradually (eg, weekly) based on response and tolerability up to 75 mg twice daily (Ref).
Agitation and/or delirium, ICU (alternative agent) (off-label use):
Note: Nonpharmacologic interventions and treatment of underlying conditions are initial steps to prevent and manage delirium. Antipsychotics may be used as short-term adjunctive treatment if distressing symptoms (eg, agitation, anxiety) are present (Ref).
Immediate release: Oral: Initial: 50 mg twice daily; may increase daily dose based on response and tolerability in 100 mg increments at intervals ≥1 day up to a maximum dose of 400 mg/day (Ref). In patients who may be more sensitive to adverse effects, some experts start at 12.5 mg twice daily or 25 to 50 mg at bedtime and increase dose more gradually (eg, in increments of 25 mg/day) based on response and tolerability (Ref).
Bipolar disorder:
Acute mania (labeled use), acute episodes with mixed features (labeled use [extended release]; off-label use [immediate release]):
Immediate release: Oral: Initial: 100 to 200 mg once daily at bedtime or in 2 divided doses on day 1, then increase by 100 mg/day (divided twice daily or as single dose at bedtime) until 400 mg/day is reached by day 4; thereafter, may further increase based on response and tolerability in increments of ≤200 mg/day (Ref). If tolerated, patients may be started at 100 mg twice daily on day 1, increased to 200 mg twice daily on day 2, and increased 300 mg twice daily on day 3 (Ref). Maximum dose: 800 mg/day (Ref); however, some patients may require doses up to 1.2 g/day for optimal response, according to some experts (Ref).
Extended release: Oral: Initial: 300 mg once daily on day 1; increase to 600 mg once daily on day 2, then adjust dose based on response and tolerability. Maximum dose: 800 mg once daily (Ref); however, some patients may require doses up to 1.2 g/day for optimal response, according to some experts (Ref).
Bipolar disorder, depressive episode (monotherapy [labeled use] or in combination [off-label use]): Immediate release, Extended release: Oral: Initial: 50 mg once daily at bedtime; increase to 100 mg once daily at bedtime on day 2, further increase by 50 to 100 mg/day to reach a usual target dose of 300 mg once daily at bedtime by day 4 to 7; maximum dose: 300 mg/day (Ref). Although increased efficacy with doses >300 mg/day has not been demonstrated in clinical trials, based upon clinical experience, individual patients may require doses up to 800 mg/day for optimal response. If doses >300 mg/day are required, the IR formulation may require 2 divided doses (Ref).
Maintenance treatment (monotherapy [off-label use] or adjunct [labeled use]): Immediate release, Extended release: Oral: Continue dose and combination regimen that was used to achieve control of the acute episode (Ref). Maximum dose: 800 mg/day; however, for patients who required doses up to 1.2 g/day to achieve remission, this dose is initially continued for maintenance treatment if it is tolerated (Ref).
Delusional infestation (delusional parasitosis) (alternative agent) (off-label use):
Immediate release: Oral: Initial: 12.5 to 50 mg at bedtime; gradually increase dose based on response and tolerability every 3 to 7 days up to 300 mg at bedtime or in 2 to 3 divided doses. Continue treatment for up to 12 months before attempting to decrease dose (Ref). Some experts suggest targeting a dose of 200 mg/day (Ref).
Generalized anxiety disorder (monotherapy or adjunct to antidepressants) (alternative agent) (off-label use):
Note: Late-line option in refractory generalized anxiety disorder, preferably use in a specialist setting (Ref). May be used for monotherapy in patients who have not responded to or do not tolerate antidepressants and other first-line agents (Ref).
Immediate release, Extended release: Oral: Initial: 25 mg once daily (immediate release only) to 50 mg once daily; may gradually increase dose based on response and tolerability every ≥7 days to a usual dosage range of 50 to 200 mg/day in 1 to 3 divided doses based on chosen formulation; maximum recommended dose: 300 mg/day (Ref). Immediate release is dosed 1 to 3 times daily; 24-hour extended release is dosed once daily. For the ER tablet, increasing the dose to 100 or 150 mg on day 3 or 4 of therapy may be appropriate for patients with severe symptoms (Ref).
Insomnia (alternative agent) (off-label use):
Note: Reserve for patients with concomitant psychiatric conditions (ie, bipolar disorder, severe anxiety disorder) (Ref).
Immediate release: Oral: Initial: 25 to 100 mg once daily at bedtime (Ref).
Extended release: Oral: Initial: 50 mg once daily at bedtime; may increase based on response and tolerability to 150 mg once daily at bedtime by as early as day 3 of treatment and 300 mg by as early as day 5 of treatment (Ref).
Major depressive disorder (unipolar):
Nonpsychotic depression as adjunct for insufficient response to antidepressants (labeled use [extended release]; off-label use [immediate release]) or psychotic depression in combination with an antidepressant (off-label use):
Immediate release, extended release: Oral: Initial: 50 mg/day on days 1 and 2; increase on day 3 to 150 mg/day in 1 to 3 divided doses based on chosen formulation. Immediate release is dosed 1 to 3 times daily; 24-hour extended release is dosed once daily. Usual dosage range: 150 to 300 mg/day in 1 to 3 divided doses based on chosen formulation (Ref); however, doses up to 600 mg/day in psychotic depression may be needed and tolerated (Ref).
Nonpsychotic depression, monotherapy (alternative agent) (off-label use):
Extended release: Oral: Initial: 50 mg once daily in the evening; increase to 150 mg once daily on day 3, then may increase to 300 mg once daily based on response and tolerability (Ref).
Obsessive-compulsive disorder, treatment resistant (augmentation to antidepressants) (off-label use):
Immediate release: Oral: Initial: 25 to 50 mg once daily; increase dose gradually based on response and tolerability in increments of 25 to 100 mg every 2 to 3 weeks up to 400 mg/day in 1 to 3 divided doses (Ref). Immediate release is dosed 1 to 3 times daily; 24-hour extended release is dosed once daily.
Posttraumatic stress disorder (adjunct to antidepressants or monotherapy) (alternative agent) (off-label use):
Immediate release: Oral: Initial: 25 mg once daily at bedtime; increase dose in 25 mg increments every 1 to 2 days up to 100 mg at bedtime by the end of week 1; may further adjust daily dose based on response and tolerability in increments of 25 mg/day, up to 100 mg/week. Average dose in clinical trials: 100 to 336 mg/day (range: 25 to 800 mg/day in 1 to 3 divided doses) (Ref). Some experts suggest an initial dose of 25 mg once daily at bedtime and if response is inadequate after 1 week, then increase the dose in increments of 50 mg per week up to 800 mg/day (Ref).
Psychosis in Parkinson disease (off-label use):
Immediate release: Oral: Initial: 12.5 to 25 mg at bedtime; increase dose gradually based on response and tolerability in increments of 12.5 to 25 mg every 1 to 2 weeks; average dose in studies ranged from 40 to 185 mg/day in 1 to 3 divided doses (Ref). Some experts gradually increase dose based on response and tolerability up to 100 mg at bedtime and then add a morning dose if needed to control symptoms, up to a maximum of 200 mg/day as tolerated (Ref).
Schizophrenia:
Immediate release: Oral: Initial: 50 mg/day in 1 or 2 divided doses, or if this is a first episode of psychosis, consider initiating at a reduced dose (eg, 12.5 mg twice daily) because these patients will be more sensitive to adverse effects. May increase daily dose based on response and tolerability in increments of 25 to 50 mg every ≥2 days to a usual dosage range of 400 to 800 mg/day in 1 to 3 divided doses. Monitor for anticholinergic effects, orthostatic hypotension, and sedation during titration. Maximum: 800 mg/day (Ref).
Extended release: Oral: Initial: 300 mg once daily in the evening, either on an empty stomach or with a light meal (≤300 calories); may increase dose based on response and tolerability in increments of up to 300 mg/day every ≥1 day. Monitor for anticholinergic effects, orthostatic hypotension, and sedation during titration. Usual dosage range: 400 to 800 mg once daily; maximum dose: 800 mg/day.
Dosing conversion: To convert patients between immediate-release and ER tablets, administer the equivalent total daily dose. Administer immediate-release daily dose in 1 to 3 divided doses and extended release once daily; individual dosage adjustments may be necessary.
Missed doses: Patients who have discontinued therapy for >1 week should generally be re-titrated using the initial dosing schedule; patients who have discontinued <1 week can generally be reinitiated on their previous maintenance dose.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Discontinuation of therapy: In the treatment of chronic psychiatric disease switching therapy rather than discontinuation is generally advised if side effects are intolerable or treatment is not effective. If patient insists on stopping treatment, gradual dose reduction (ie, over several weeks to months) is advised to detect a re-emergence of symptoms and to avoid withdrawal reactions (eg, agitation, alternating feelings of warmth and chill, anxiety, diaphoresis, dyskinesias, GI symptoms, insomnia, irritability, myalgia, paresthesia, psychosis, restlessness, rhinorrhea, tremor, vertigo) unless discontinuation is due to significant adverse effects. Monitor closely to allow for detection of prodromal symptoms of disease recurrence (Ref).
Switching antipsychotics: An optimal universal strategy for switching antipsychotic drugs has not been established. Strategies include: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic) and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). In patients with schizophrenia at high risk of relapse, the current medication may be maintained at full dose as the new medication is increased (ie, overlap); once the new medication is at therapeutic dose, the first medication is gradually decreased and discontinued over 1 to 2 weeks (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
No dosage adjustment necessary (Ref). Removal by dialysis unlikely due to relatively high protein binding and large volume of distribution (Ref).
The liver dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Matt Harris, PharmD, MHS, BCPS, FAST, FCCP; Jeong Park, PharmD, MS, BCTXP, FCCP, FAST; Arun Jesudian, MD; Sasan Sakiani, MD.
Note: Manufacturer recommendations do not specify the level of liver insufficiency associated with dosing recommendations. Pharmacokinetic data are limited to a single dose study performed in 8 patients with unspecified (eg, no Child-Turcotte-Pugh designation) liver insufficiency; AUC, Cmax, and Vd were substantially higher and clearance impaired compared to healthy controls. Notably, patients with ascites, encephalopathy, or liver transaminases >3 ULN were excluded (Ref).
Liver impairment prior to treatment initiation:
Initial or dose adjustment in patients with preexisting liver cirrhosis: Note: Although quetiapine-induced liver injury is rare, changes in liver biochemistries are common; therefore, liver biochemistries should be obtained at baseline, then at 6 weeks and every 3 months during the first year of therapy for patients with liver cirrhosis, then annually thereafter or when clinically indicated (Ref).
Child-Turcotte-Pugh class A and B:
Immediate release: Oral: Initial: 25 mg once daily; may increase total daily dose gradually (eg, 25 to 50 mg increments) based on response and tolerability until effective dose achieved, dividing total daily dose into 1 to 3 divided doses (Ref).
Extended release: Oral: Initial: 50 mg once daily; increase dose by 50 mg once daily until effective dose achieved based on individual clinical response and tolerability (Ref).
Note: Extended release should not be used for initial dosing in patients with cirrhosis who are quetiapine naive (Ref).
Child-Turcotte-Pugh class C: Avoid use (Ref).
Liver impairment developing in patient already receiving quetiapine:
Chronic disease progression (eg, outpatient):
Baseline to Child-Turcotte-Pugh class A through C:
Immediate release, extended release: Assess for quetiapine-induced liver injury, and if suspected, discontinue quetiapine (Ref). If quetiapine-induced hepatoxicity has been ruled out, may continue quetiapine therapy; use the lowest effective dose; consider dose reduction or interruption in therapy for new or worsening somnolence and/or hepatic encephalopathy in collaboration with an appropriate specialist (eg, psychiatrist) (Ref).
Acute worsening liver function (eg, requiring hospitalization):
Progression to Child-Turcotte-Pugh class A through C:
Immediate release, extended release: Assess for quetiapine-induced liver injury, and if suspected, discontinue quetiapine (Ref). If quetiapine-induced hepatoxicity has been ruled out, may continue quetiapine therapy; use the lowest effective dose; consider dose reduction or interruption in therapy for new or worsening somnolence and/or hepatic encephalopathy in collaboration with an appropriate specialist (eg, psychiatrist) (Ref).
Angioedema may occur with use of quetiapine (Ref).
Mechanism: Unknown; both a nonallergic and allergic mechanism have been proposed with antipsychotic-induced angioedema, including IgE-related hypersensitivity, kinin-dependent processes, or C1-esterase inhibition deficiencies (Ref).
Onset: Varied; onset following olanzapine use has been described within several days (Ref). When angioedema has occurred following use of other antipsychotics, onset has occurred within minutes to years (Ref).
Risk factors:
• Cross-reactivity: The risk of cross-reactivity between antipsychotics as it relates to angioedema events is not well established; however, cross-reactivity has been described between clozapine and olanzapine, haloperidol and iloperidone, and haloperidol and aripiprazole (Ref).
Anticholinergic activity of quetiapine at usual therapeutic doses is generally considered low relative to other second-generation antipsychotics (eg, clozapine) (Ref). However, dose-dependent increases in anticholinergic activity have been observed (Ref). Anticholinergic effects may include constipation, urinary retention (case report in a patient receiving a high dose), xerostomia, and blurred vision. In older adults, some scales have classified quetiapine as having a high anticholinergic burden which may lead to new-onset delirium, cognitive dysfunction, confusion, and falling. However, there is no standardized tool for measuring anticholinergic burden in older adults and some scales have also rated quetiapine as low or moderate (Ref).
Mechanism: Dose-related; believed to be mediated primarily through active metabolite, norquetiapine antagonism at muscarinic receptors. Variability in conversion to norquetiapine may be a factor involved in inconsistency in reports associated with quetiapine’s anticholinergic adverse reactions (Ref).
Risk factors:
Variable and dependent upon:
• Total anticholinergic burden (Ref)
• Baseline cognitive function (Ref)
• Comorbidities (Ref)
• Polypharmacy (Ref)
• Older adults (Ref)
• Interindividual variability of the pharmacokinetic and pharmacodynamic parameters (Ref)
There is insufficient evidence that quetiapine is associated with an increased risk of cataract development in humans, despite warnings in the manufacturer's labeling. There are some case reports of cataracts occurring in patients receiving quetiapine (Ref); however, a large population-based, nested case control study did not find an association between atypical antipsychotics and risk of cataract development in patients with schizophrenia (Ref). The concern stems from animal research observing cataracts in beagles receiving quetiapine at 4 times the recommended human dose (this was not observed in other animal studies) and cataracts occurring in patients receiving certain phenothiazine neuroleptic medications, such as chlorpromazine (Ref).
Antipsychotics are associated with dyslipidemia in adult and pediatric patients, which is a component of the metabolic syndrome observed with this pharmacologic class. Dyslipidemia observed with quetiapine primarily manifests as hypertriglyceridemia (increased serum triglycerides), including cases of severe hypertriglyceridemia (>600 mg/dL) and acute pancreatitis (some cases were fatal). Hypercholesterolemia (increased LDL cholesterol, increased serum cholesterol, decreased HDL cholesterol) may also occur with use (Ref).
Mechanism: The mechanism is not entirely understood and is likely multifactorial (Ref).
Onset: Varied; metabolic alterations from antipsychotics can develop in as short as 3 months after initiation (Ref). In cases of hypertriglyceridemia-induced acute pancreatitis due to quetiapine, almost all occurred within the first 8 months of an established dose and most frequently at 3 months of treatment (Ref).
Risk factors:
• History of preexisting dyslipidemia or hypertriglyceridemia (Ref)
• Schizophrenia (regardless of medication use) is associated with a higher rate of morbidity/mortality compared to the general population primarily due to cardiovascular disease (Ref).
• Specific antipsychotic: Some authors consider quetiapine to have a high risk of hyperlipidemia, while others consider quetiapine’s risk to be intermediate (Ref). Overall, metabolic disturbances appear to be the greatest with clozapine and olanzapine and intermediate with quetiapine (Ref).
Quetiapine may cause extrapyramidal symptoms (EPS), also known as drug-induced movement disorders. Antipsychotics can cause 4 main EPS: Acute dystonia, drug-induced parkinsonism, akathisia, and tardive dyskinesia (Ref). EPS presenting as dysphagia, esophageal dysmotility, or aspiration have also been reported with antipsychotics, which may not be recognized as EPS (Ref).
Mechanism: EPS: Dose-related; due to antagonism of dopaminergic D2 receptors in nigrostriatal pathways (Ref). Tardive dyskinesia: Time related (delayed); results from chronic exposure to dopamine 2 receptor antagonists leading to up-regulation of these receptors over time (Ref).
Onset:
Antipsychotics in general:
Acute dystonia: Rapid; in the majority of cases, dystonia usually occurs within the first 5 days after initiating antipsychotic therapy (and even with the first dose, particularly in patients receiving parenteral antipsychotics) or a dosage increase (Ref).
Drug-induced parkinsonism: Varied; onset may be delayed from days to weeks, with 50% to 75% of cases occurring within 1 month and 90% within 3 months of antipsychotic initiation, a dosage increase, or a change in the medication regimen (such as adding another antipsychotic agent or discontinuing an anticholinergic medication) (Ref).
Akathisia: Varied; may begin within several days after antipsychotic initiation but usually increases with treatment duration, occurring within 1 month in up to 50% of cases and within 3 months in 90% of cases (Ref).
Tardive dyskinesia: Delayed; symptoms usually appear after 1 to 2 years of continuous exposure to a dopamine 2 receptor antagonist, and almost never before 3 months, with an insidious onset, evolving into a full syndrome over days and weeks, followed by symptom stabilization and then a chronic waxing and waning of symptoms (Ref).
Esophageal dysfunction (associated with EPS): Varied; ranges from weeks to months following initiation (Ref).
Risk factors:
EPS (in general):
• Prior history of EPS (Ref)
• Higher doses (Ref)
• Younger age (in general, children and adolescents are usually at higher risk for EPS compared to adults) (Ref)
• Specific antipsychotic: Quetiapine is considered to have a low propensity to cause EPS (Ref)
Acute dystonia:
• Males (Ref)
• Young age (Ref)
Drug-induced parkinsonism:
• Females (Ref)
• Older patients (Ref)
Akathisia:
• Higher antipsychotic dosages (Ref)
• Polypharmacy (Ref)
• Mood disorders (Ref)
• Females (Ref)
• Older patients (Ref)
Tardive dyskinesia:
• Age >55 years (Ref)
• Cognitive impairment (Ref)
• Concomitant treatment with anticholinergic medications (Ref)
• Diabetes (Ref)
• Diagnosis of schizophrenia or affective disorders (Ref)
• Females (Ref)
• Greater total antipsychotic exposure (especially first-generation antipsychotics) (Ref)
• History of extrapyramidal symptoms (Ref)
• Substance misuse or dependence (Ref)
• Race (White or African descent). Note: Although early literature supported race as a potential risk factor for tardive dyskinesia (Morgenstern 1993), newer studies have challenged this assertion (Ref).
Esophageal dysfunction (associated with EPS):
• Certain comorbidities such as neurologic degenerative disease, dementia, stroke, Parkinson disease, or myasthenia gravis (Ref)
• Older adults >75 years of age (may be risk factor due to age related muscle atrophy, cognitive impairment, or reduced esophageal peristalsis) (Ref)
Leukopenia, neutropenia, and thrombocytopenia have been reported with quetiapine monotherapy (Ref). Agranulocytosis, including fatal agranulocytosis, has also been reported, including with monotherapy (Ref). The majority of reports involving quetiapine-associated leukopenia or neutropenia involve patients receiving concomitant valproate (Ref). In addition, there are case reports of thrombotic thrombocytopenic purpura (TTP) and autoimmune hemolytic anemia (AIHA) (pediatric patient) (Ref).
Mechanism: Unknown; hypothesized as the same direct toxicity or immune-mediated destruction as clozapine, due to chemical structure similarities (Ref). TTP and AIHA may occur due to a drug-induced immune response (Ref).
Onset: Varied; in general, drug-induced neutropenia usually manifests after 1 or 2 weeks of exposure and agranulocytosis usually appears 3 to 4 weeks following initiation of therapy; however, the onset may be insidious (Ref). For TTP, one case report described an onset within a few days after exposure with early thrombocytopenia, followed by delayed appearance (2 to 3 days) of microangiopathic hemolysis (Ref).
Risk factors:
• History of drug-induced leukopenia/neutropenia or low white blood cell count/absolute neutrophil count
• Older adults (Ref)
• Concomitant use of valproate (which is also associated with causing blood dyscrasias and may increase quetiapine concentrations by 77% via a drug-drug interaction) (Ref).
Quetiapine can cause asymptomatic, low-level (<3 times ULN), transient increases in liver biochemistries (Ref). Rare cases of significant hepatoxicity, including fulminant hepatic failure requiring discontinuation, have been reported with incidence of severe liver damage occurring in 1.64% of patients in a multi-center cohort evaluation (Ref). Quetiapine-induced hepatoxicity can present as hepatocellular, mixed, or cholestatic (eg, elevated bilirubin and alkaline phosphatase) with or without components of autoimmune hepatitis (eg, low levels of anti-smooth muscle antibody titers; eosinophilia) (Ref).
Mechanism: Non–dose-related; idiosyncratic (Ref).
Onset: Varied; 3 days to 1 month, latency up to 8 years has been noted with a quicker onset upon rechallenge (Ref).
Risk factors:
• Preexisting liver disease (Ref)
• Concurrent use of hepatoxic drugs (Ref)
• Older age (≥65 years of age) (Ref)
• Female sex (Ref)
• Prior hepatotoxicity with another atypical antipsychotic agent requiring discontinuation (Ref)
• Diabetes (Ref)
• Hyperlipidemia (Ref)
• Obesity (Ref)
Antipsychotics are associated with hyperglycemia, to varying degrees, which is a component of the metabolic syndrome observed with this pharmacologic class. Glycemic abnormalities range from mild insulin resistance or hyperglycemia to new-onset diabetes mellitus and diabetic ketoacidosis, including fatal cases (Ref).
Mechanism: The mechanism is not entirely understood and is likely multifactorial (Ref).
Onset: Varied; new-onset diabetes has been observed within first 3 months to a median onset of 3.9 years (Ref).
Risk factors:
Antipsychotics in general:
• African American race (Ref)
• Males (Ref)
• Age <35 years (Ref)
• Preexisting obesity, poor exercise habits, or other risk factors for diabetes, including family history of diabetes (Ref)
• Exposure to other agents that also increase the risk of hyperglycemia (Ref)
• Type 2 diabetes mellitus: Extended exposure (mean: 17.2 months) in pediatric patients 10 to 18 years (Ref)
• Specific antipsychotic: Quetiapine is associated with a moderate risk of hyperglycemia (Ref)
Hypothyroidism has been observed with quetiapine use, including cases requiring discontinuation or initiation of thyroid replacement therapy, and one case with spontaneous resolution without quetiapine discontinuation (Ref). However, some studies have observed changes in total thyroxine (T4) levels only, without a significant increase in thyroid stimulating hormone (TSH) levels (Ref).
Mechanism: The mechanism of action by which quetiapine causes hypothyroidism is unknown (Ref). It has been presumed to result from thyroid gland dysfunction (primary hypothyroidism); although, due to the presence of a low T4 without TSH changes, in many cases, a central [secondary] hypothyroidism rather than a primary hypothyroidism may also be a potential mechanism (Ref).
Risk factors:
• Higher quetiapine doses (Ref)
In general (regardless of quetiapine use):
• Bipolar disorder (overt or subclinical hypothyroidism [more common]) (Ref)
• Schizophrenia (thyroid dysfunction) (Ref)
• Concomitant lithium treatment (may induce or exacerbate preexisting hypothyroidism) (Ref)
Older adults with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Of note, quetiapine is not approved for the treatment of dementia-related psychosis (Ref).
Mechanism: Unknown; possible mechanisms include arrhythmia, cardiac arrest, and extrapyramidal effects that may increase the risk of falls, aspirations, and pneumonia (Ref).
Risk factors:
Antipsychotics in general:
• Higher antipsychotic dosage (Ref)
• Dementia-related psychosis (eg, Lewy body dementia, Parkinson disease dementia)
• Older adults
All antipsychotics have been associated with neuroleptic malignant syndrome (NMS) in all ages. First-generation antipsychotic-associated NMS seems to occur at a higher frequency, severity, and lethality compared to second-generation antipsychotic-associated NMS (Ref). There are case reports of NMS with quetiapine monotherapy, although most involve concomitant administration of another neuroleptic or other confounding conditions (Ref).
Mechanism: Non–dose-related; idiosyncratic. Believed to be due to a reduction in CNS dopaminergic tone, along with the dysregulation of autonomic nervous system activity (Ref).
Onset: Varied; in general, most patients develop NMS within 2 weeks of initiating an antipsychotic, and in some patients, prodromal symptoms emerge within hours of initiation; once the syndrome starts, the full syndrome usually develops in 3 to 5 days (Ref). In a review of the few cases reported with quetiapine, the mean time of onset was 21 days (median: 9 days) (Ref). However, there are many cases of NMS occurring months after stable antipsychotic therapy (Ref).
Risk factors:
Antipsychotics in general:
• Males (twice as likely to develop NMS compared to females) (Ref)
• Dehydration (Ref)
• High-dose antipsychotic treatment (Ref)
• Concomitant lithium or benzodiazepine (potential risk factors) (Ref)
• Catatonia (Ref)
• Disorganized speech or behavior (Ref)
• Polypharmacy (Ref)
• Pharmacokinetic interactions (Ref)
• Intramuscular administration (Ref)
• Rapid dosage escalation (Ref)
• Psychomotor agitation (Ref)
Quetiapine may cause orthostatic hypotension and accompanying tachycardia and syncope in adults, particularly with rapid titration (Ref). Orthostatic hypotension may result in subsequent falling and fracture, particularly in older adults (Ref).
Mechanism: Orthostatic hypotension is attributed to alpha-1 adrenergic receptor antagonism (Ref).
Onset: Rapid; per the manufacturer's labeling, orthostatic hypotension is most common in the first few days of initiation or following a dosage increase; may also occur after only 1 dose (Ref).
Risk factors:
• Known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure, or conduction abnormalities) or cerebrovascular disease
• Known predisposing conditions (eg, hypovolemia/dehydration)
• Concomitant medications that also cause or exacerbate orthostatic hypotension (eg, tricyclic antidepressants, antihypertensive medications)
• Older adults (Ref)
• Rapid dose titration (Ref)
Quetiapine has been associated with prolonged QT interval on ECG, including rare reports of torsades de pointes (TdP), ventricular arrhythmia, and sudden cardiac death, predominately in the setting of overdose or in patients with multiple risk factors (Ref). Of the antipsychotics, quetiapine is generally associated with a moderate risk for QTc prolongation (Ref); contrasting data also exist which may indicate a milder impact on QT interval (Ref). In a study of healthy adult volunteers designed to evaluate the QTc prolongation potential of a single dose of quetiapine immediate release (100 mg), the mean change in QTc was 13.7 msec (Ref). In another study in 27 healthy patients receiving psychiatric care, reaching steady state on quetiapine 750 mg/day, the mean change in QTc was 5.7 msec (Ref). A prospective cohort analysis of critically ill patients who received quetiapine for the treatment of delirium (n=103) found that, in patients who experienced QTc prolongation, the median change in QTc interval was 20 msec (Ref).
Mechanism: Likely dose-related (Ref). Quetiapine prolongs cardiac repolarization by blocking the rapid component of the delayed rectifier potassium current (Ikr) (Ref).
Risk factors:
Drug-induced QTc prolongation (in general):
• Females (Ref)
• Age >65 years (Ref)
• Structural heart disease (eg, history of myocardial infarction or heart failure with a reduced ejection fraction) (Ref)
• History of drug-induced TdP (Ref)
• Genetic defects of cardiac ion channels (Ref)
• Congenital long QT syndrome (Ref)
• Baseline QTc interval prolongation (eg, >500 msec) or lengthening of the QTc by ≥60 msec (Ref)
• Electrolyte disturbances (eg, hypokalemia, hypocalcemia, hypomagnesemia) (Ref)
• Bradycardia (Ref)
• Hepatic impairment (Ref)
• Kidney impairment (Ref)
• Coadministration of multiple medications (≥2) that prolong the QT interval or increase drug interactions that increase serum drug concentrations of QTc prolonging medications (Ref)
• Substance use (Ref)
Sedated state (drowsiness) has been reported with use; may cause nonadherence and impair physical and/or mental abilities resulting in subsequent falling and fracture, particularly in older adults (Ref).
Mechanism: Dose-related; sedation is believed to be due to H1 antagonism leading to potential CNS depressant effects (Ref).
Onset: Rapid; per the manufacturer’s labeling, sedation is most common in the first few days of initiation or following a dosage increase.
Antipsychotics have been associated with sexual disorder in both males and females. Antipsychotic treatment has been associated with effects on all phases of sexual activity (libido, arousal, orgasm); however, many patients with schizophrenia experience more frequent sexual dysfunction, with or without antipsychotic treatment (Ref). Decreased libido, erectile dysfunction, and abnormal orgasm have been reported with quetiapine (Ref).
Mechanism: Antipsychotic-induced sexual dysfunction has been attributed to many potential mechanisms, including dopamine receptor antagonism, dopamine D2 receptor antagonism in the infundibular dopaminergic pathway causing hyperprolactinemia, histamine receptor antagonism, cholinergic receptor antagonism, and alpha-adrenergic receptor antagonism. Quetiapine is associated with a minimal risk of causing hyperprolactinemia in adults (Ref); however, clinically significant prolactin levels have been observed in pediatric patients (ages 10 to 17 years).
Risk factors:
• Hyperprolactinemia (although a correlation with sexual dysfunction has been observed, a relationship has not been confirmed) (Ref)
• Schizophrenia (the prevalence antipsychotic-induced sexual dysfunction in patients with schizophrenia is high [~50% to 60% compared with 31% of males in the general population]) (Ref)
• Specific antipsychotic: Quetiapine is usually associated with relatively lower rates of sexual dysfunction compared to other antipsychotics, such as risperidone and haloperidol (Ref)
Antipsychotics may impair the body’s ability to regulate core body temperature, which may cause a potentially life-threatening heat stroke during predisposing conditions such as a heat wave or strenuous exercise. There are also several case reports of potentially life-threatening hypothermia associated with quetiapine use (Ref).
Mechanism: Non–dose-related; idiosyncratic. Exact mechanism is unknown; however, body temperature is regulated by the hypothalamus with involvement of the dopamine, serotonin, and norepinephrine neurotransmitters. D2 antagonism may cause an increase in body temperature, while 5-HT2A (serotonin) receptor antagonism may cause a decrease in body temperature. In addition, antagonism of peripheral alpha-adrenergic receptors has also been suggested as a factor in the hypothermic effect, by inhibiting peripheral responses to cooling (vasoconstriction and shivering) (Ref).
Onset: Hypothermia: Varied; antipsychotic-induced hypothermia cases indicate a typical onset in the period shortly after initiation of therapy or a dosage increase (first 7 to 10 days) (Ref).
Risk factors:
Heat stroke:
• Psychiatric illness (regardless of medication use) (Ref)
• Dehydration (Ref)
• Strenuous exercise (Ref)
• Heat exposure (Ref)
• Concomitant medications possessing anticholinergic effects (Ref)
Hypothermia:
• In general, predisposing risk factors include: Older adults, cerebrovascular accident, preexisting brain damage, hypothyroidism, malnutrition, shock, sepsis, adrenal insufficiency, diabetes, disability, burns, exfoliative dermatitis, benzodiazepine use, alcohol intoxication, kidney or liver failure (Ref)
• Schizophrenia (regardless of antipsychotic use) (Ref)
Quetiapine is associated with significant weight gain (increase of ≥7% from baseline) in adult and pediatric patients, which is a component of the metabolic syndrome observed with this pharmacologic class (Ref).
Mechanism: Dose-related (Ref); multiple proposed mechanisms, including actions at serotonin, dopamine, histamine, and muscarinic receptors, with differing effects explained by differing affinity of antipsychotics at these receptors (Ref).
Onset: Varied; antipsychotic-induced weight gain usually occurs rapidly in the initial period following initiation, then gradually decreases and plateaus over several months with patients continuing to gain weight in the long term (Ref).
Risk factors:
• Family history of obesity (Ref)
• Parental BMI (Ref)
• Children and adolescents (Ref)
• Rapid weight gain in the initial period: Younger patients, lower baseline BMI, more robust response to antipsychotic, and increase in appetite; rapid weight gain of >5% in the first month has been observed as the best predictor for significant long-term weight gain (Ref)
• Duration of therapy (although weight gain plateaus, patients continue to gain weight over time) (Ref)
• Schizophrenia (regardless of medication) is associated with a higher prevalence of obesity compared to the general population due to components of the illness such as negative symptoms, sedentary lifestyles, and unhealthy diets (Ref).
• Specific antipsychotic: Quetiapine is considered to display moderate propensity for weight gain (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Actual frequency may be dependent upon dose and/or indication. Unless otherwise noted, frequency of adverse effects is reported for adult patients; spectrum and incidence of adverse effects similar in children (with significant exceptions noted).
>10%:
Cardiovascular: Increased diastolic blood pressure (≥10 mm Hg; children, adolescents: 41% to 47%), increased systolic blood pressure (≥20 mm Hg; children, adolescents: 7% to 15%), orthostatic hypotension (children, adolescents: <1%; adults: 2% to 7%; older adults: literature suggests the incidence may be as high as 18%) (Ref) (table 1), tachycardia (≤11%) (table 2)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
Source |
|---|---|---|---|---|---|---|---|---|
|
4% |
3% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
Prescribing information |
|
2% |
1% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
Prescribing information |
|
3% |
0% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
Prescribing information |
|
7% |
5% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
Prescribing information |
|
4% |
1% |
Adults |
IR tablets |
75 to 800 mg/day |
Schizophrenia and bipolar mania |
719 |
404 |
Prescribing information |
|
18% |
3% |
Older adults |
IR tablets |
400 to 800 mg/day |
Bipolar mania |
28 |
31 |
Sajatovic 2008 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
9% |
0% |
Children & adolescents |
IR tablets |
600 mg |
Bipolar mania |
98 |
90 |
|
6% |
0% |
Children & adolescents |
IR tablets |
400 mg |
Bipolar mania |
95 |
90 |
|
11% |
0% |
Adolescents |
IR tablets |
800 mg |
Schizophrenia |
74 |
75 |
|
6% |
0% |
Adolescents |
IR tablets |
400 mg |
Schizophrenia |
73 |
75 |
|
0.5% |
0% |
Adults |
IR tablets |
N/A |
Acute bipolar mania |
192 |
178 |
|
2% |
1% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
3% |
1% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
6% |
4% |
Adults |
IR tablets |
75 to 800 mg/day |
Schizophrenia and bipolar mania |
719 |
404 |
|
2% |
0.5% |
Adults |
XR tablets |
N/A |
N/A |
N/A |
N/A |
Endocrine & metabolic: Decreased HDL cholesterol (≤40 mg/dL: 9% to 20%) (table 3), hypercholesterolemia (7% to 18%) (table 4), increased serum triglycerides (8% to 28%) (table 5), weight gain (4% to 23%) (table 6)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|
|
20% |
15% |
Children & adolescents |
XR tablets |
Bipolar disorder, depressive episode |
65 |
74 |
|
10% |
7% |
Children & adolescents |
IR tablets |
Bipolar mania |
154 |
61 |
|
15% |
19% |
Children & adolescents |
IR tablets |
Schizophrenia |
104 |
54 |
|
14% |
14% |
Adults |
IR tablets |
Bipolar disorder, depressive episode |
393 |
214 |
|
9% |
7% |
Adults |
XR tablets |
Bipolar disorder, depressive episode |
78 |
83 |
|
19% |
13% |
Adults |
XR tablets |
Bipolar mania |
100 |
115 |
|
15% |
12% |
Adults |
XR tablets |
Schizophrenia |
600 |
195 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
8% |
6% |
Children & adolescents |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
83 |
84 |
|
10% |
3% |
Children & adolescents |
IR tablets |
N/A |
Bipolar mania |
159 |
66 |
|
12% |
2% |
Children & adolescents |
IR tablets |
N/A |
Schizophrenia |
107 |
56 |
|
9% |
6% |
Adults |
IR tablets |
N/A |
Bipolar disorder, depressive episode |
463 |
250 |
|
7% |
3% |
Adults |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
85 |
106 |
|
7% |
4% |
Adults |
XR tablets |
N/A |
Bipolar mania |
128 |
134 |
|
18% |
7% |
Adults |
IR tablets |
N/A |
Schizophrenia |
137 |
92 |
|
9% |
9% |
Adults |
XR tablets |
N/A |
Schizophrenia |
718 |
232 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
28% |
9% |
Children & adolescents |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
80 |
82 |
|
22% |
13% |
Children & adolescents |
IR tablets |
N/A |
Bipolar mania |
149 |
60 |
|
17% |
8% |
Children & adolescents |
IR tablets |
N/A |
Schizophrenia |
103 |
51 |
|
14% |
9% |
Adults |
IR tablets |
N/A |
Bipolar disorder, depressive episode |
436 |
232 |
|
8% |
8% |
Adults |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
84 |
93 |
|
15% |
6% |
Adults |
XR tablets |
N/A |
Bipolar mania |
102 |
125 |
|
22% |
16% |
Adults |
IR tablets |
N/A |
Schizophrenia |
120 |
70 |
|
18% |
5% |
Adults |
XR tablets |
N/A |
Schizophrenia |
659 |
214 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|---|---|---|---|
|
21% |
7% |
Adolescents |
IR tablets |
N/A |
Schizophrenia |
111 |
44 |
≥7% of Body Weight |
|
15% |
10% |
Children & adolescents |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
92 |
100 |
≥7% of Body Weight |
|
12% |
0% |
Children & adolescents |
IR tablets |
N/A |
Bipolar mania |
157 |
68 |
≥7% of Body Weight |
|
6% |
0% |
Children & adolescents |
IR tablets |
400 to 600 mg/day |
Bipolar mania |
193 |
90 |
N/A |
|
8% |
2% |
Adults |
IR tablets |
N/A |
Bipolar disorder, depressive episode |
554 |
295 |
≥7% of Body Weight |
|
8% |
1% |
Adults |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
110 |
125 |
≥7% of Body Weight |
|
7% |
1% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
N/A |
|
4% |
1% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
N/A |
|
21% |
7% |
Adults |
IR tablets |
N/A |
Bipolar mania |
209 |
198 |
≥7% of Body Weight |
|
7% |
1% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
N/A |
|
5% |
0% |
Adults |
XR tablets |
N/A |
Bipolar mania |
138 |
150 |
≥7% of Body Weight |
|
23% |
6% |
Adults |
IR tablets |
N/A |
Schizophrenia |
391 |
206 |
≥7% of Body Weight |
|
10% |
5% |
Adults |
XR tablets |
N/A |
Schizophrenia |
907 |
299 |
≥7% of Body Weight |
|
5% |
1% |
Adults |
IR tablets |
75 to 800 mg/day |
Schizophrenia and bipolar mania |
719 |
404 |
N/A |
Gastrointestinal: Increased appetite (2% to 12%), xerostomia (children and adolescents: 4% to 10%; adults: 9% to 44%) (table 7)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
7% |
0% |
Children & adolescents |
IR tablets |
400 to 600 mg/day |
Bipolar mania |
193 |
90 |
|
10% |
1% |
Adolescents |
IR tablets |
800 mg/day |
Schizophrenia |
74 |
75 |
|
4% |
1% |
Adolescents |
IR tablets |
400 mg/day |
Schizophrenia |
73 |
75 |
|
44% |
13% |
Adults |
IR tablets |
300 and 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
|
37% |
7% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
34% |
7% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
12% |
1% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
9% |
3% |
Adults |
IR tablets |
75 to 800 mg/day |
Schizophrenia and bipolar mania |
719 |
404 |
Hematologic & oncologic: Decreased hemoglobin (8% to 11%)
Nervous system: Agitation (20%), dizziness (7% to 19%), drowsiness (18% to 57% including sedated state) (table 8), extrapyramidal reaction (1% to 13%), fatigue (3% to 14%), headache (21%), withdrawal syndrome (12%)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
57% |
14% |
Children & adolescents |
IR tablets |
600 mg/day |
Bipolar mania |
98 |
90 |
|
50% |
14% |
Children & adolescents |
IR tablets |
400 mg/day |
Bipolar mania |
95 |
90 |
|
35% |
11% |
Adolescents |
IR tablets |
800 mg/day |
Schizophrenia |
74 |
75 |
|
33% |
11% |
Adolescents |
IR tablets |
400 mg/day |
Schizophrenia |
73 |
75 |
|
57% |
15% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
|
52% |
13% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
50% |
12% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
25% |
10% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
18% |
8% |
Adults |
IR tablets |
75 to 800 mg/day |
Schizophrenia and bipolar mania |
719 |
404 |
1% to 10%:
Cardiovascular: Hypotension (3%), palpitations (4%), syncope (1% to 2%) (table 9)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
2% |
0% |
Children & adolescents |
IR tablets |
400 to 600 mg/day |
Bipolar mania |
193 |
90 |
|
1% |
0.2% |
N/A |
IR tablets |
N/A |
N/A |
3,265 |
954 |
Dermatologic: Acne vulgaris (children, adolescents: 2% to 3%), hyperhidrosis (2%), pallor (children, adolescents: 1% to 2%), skin rash (4%)
Endocrine & metabolic: Decreased free T4 (3%), decreased libido (2%) (table 10), decreased total T4 (≤3%), hyperglycemia (fasting glucose <100 mg/dL to ≥126 mg/dL: 2%) (table 11), hyperprolactinemia (4%), increased LDL cholesterol (2% to 8%) (table 12), increased thirst (children, adolescents: 2%), increased thyroid stimulation hormone level (≤3%)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
2% |
1% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|---|---|---|---|
|
2% |
1% |
Adults |
IR and XR tablets |
N/A |
N/A |
2,907 |
1,346 |
Normal to high (<100 mg/dL to ≥126 mg/dL) |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
2% |
4% |
Children & adolescents |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
86 |
85 |
|
8% |
5% |
Children & adolescents |
IR tablets |
N/A |
Bipolar mania |
169 |
74 |
|
4% |
2% |
Children & adolescents |
IR tablets |
N/A |
Schizophrenia |
112 |
60 |
|
6% |
5% |
Adults |
IR tablets |
N/A |
Bipolar disorder, depressive episode |
465 |
256 |
|
4% |
2% |
Adults |
XR tablets |
N/A |
Bipolar disorder, depressive episode |
86 |
104 |
|
4% |
2% |
Adults |
XR tablets |
N/A |
Bipolar mania |
125 |
135 |
|
7% |
8% |
Adults |
XR tablets |
N/A |
Schizophrenia |
691 |
227 |
Gastrointestinal: Abdominal pain (1% to 4%), anorexia (1% to 3%), constipation (2% to 10%) (table 13), decreased appetite (2%), diarrhea (children, adolescents: 5%), dyspepsia (5% to 7%), dysphagia (2%) (table 14), gastroenteritis (2%), nausea (5% to 10%), periodontal abscess (adolescents: 1% to 3%), toothache (2% to 3%), vomiting (5% to 8%)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
4% |
0% |
Children & adolescents |
IR tablets |
400 mg/day |
Bipolar mania |
95 |
90 |
|
2% |
0% |
Children & adolescents |
IR tablets |
600 mg/day |
Bipolar mania |
98 |
90 |
|
10% |
4% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
|
8% |
6% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
10% |
3% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
6% |
5% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
8% |
3% |
Adults |
IR tablets |
75 to 800 mg/day |
Schizophrenia and bipolar mania |
719 |
404 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
2% |
0% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
Genitourinary: Pollakiuria (2%), urinary tract infection (2%)
Hematologic & oncologic: Neutropenia (≤2%) (table 15)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
Comments |
|---|---|---|---|---|---|---|---|---|
|
2% |
0.8% |
N/A |
IR tablets |
N/A |
N/A |
N/A |
N/A |
Neutrophil count <1.5 x 109/L |
|
2% |
0.8% |
N/A |
XR tablets |
N/A |
N/A |
N/A |
N/A |
Neutrophil count <1.5 x 109/L |
|
0.3% |
0.1% |
Adults |
N/A |
N/A |
N/A |
3368 |
1515 |
Neutrophil count <1.0 x 109/L |
Hepatic: Increased serum alanine aminotransferase (5%), increased serum aspartate aminotransferase (3%), increased serum transaminases (1% to 6%)
Nervous system: Abnormal dreams (2% to 3%), aggressive behavior (children, adolescents: 1% to 3%), akathisia (≤5%) (table 16), anxiety (2% to 4%), asthenia (1% to 5%), ataxia (2%), confusion (2%) (table 17), decreased mental acuity (2%), disorientation (2%), disturbance in attention (2%), dysarthria (2% to 5%), hypersomnia (2% to 3%), hypoesthesia (2%), irritability (3% to 5%), lethargy (2% to 5%), migraine (2%), pain (7%), paresthesia (2% to 3%), parkinsonism (≤6%) (table 18), restless leg syndrome (2%), restlessness (2%), tremor (2%)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
1% |
0% |
Children & adolescents |
IR tablets |
400 to 600 mg/day |
Bipolar mania |
193 |
90 |
|
5% |
4% |
Adolescents |
IR tablets |
800 mg/day |
Schizophrenia |
74 |
75 |
|
4% |
4% |
Adolescents |
IR tablets |
400 mg/day |
Schizophrenia |
73 |
75 |
|
4% |
1% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
|
2% |
0% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
1% |
0.6% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
2% |
8% |
Adults |
IR tablets |
75 mg/day |
Schizophrenia |
53 |
51 |
|
2% |
8% |
Adults |
IR tablets |
150 mg/day |
Schizophrenia |
48 |
51 |
|
2% |
8% |
Adults |
IR tablets |
750 mg/day |
Schizophrenia |
54 |
51 |
|
0% to 2% |
1% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
0% |
8% |
Adults |
IR tablets |
300 mg/day |
Schizophrenia |
52 |
51 |
|
0% |
8% |
Adults |
IR tablets |
600 mg/day |
Schizophrenia |
51 |
51 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
2% |
0% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
2% |
1% |
Children & adolescents |
IR tablets |
400 mg |
Bipolar mania |
95 |
90 |
|
1% |
1% |
Children & adolescents |
IR tablets |
600 mg |
Bipolar mania |
98 |
90 |
|
6% |
3% |
Adolescents |
IR tablets |
400 mg |
Schizophrenia |
73 |
75 |
|
5% |
3% |
Adolescents |
IR tablets |
800 mg |
Schizophrenia |
74 |
75 |
|
0.7% |
0.7% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
3% |
2% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
4% |
8% |
Adults |
IR tablets |
75 mg/day |
Schizophrenia |
53 |
51 |
|
1% to 4% |
1% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
2% |
8% |
Adults |
IR tablets |
300 mg/day |
Schizophrenia |
52 |
51 |
|
2% |
8% |
Adults |
IR tablets |
600 mg/day |
Schizophrenia |
51 |
51 |
|
2% |
8% |
Adults |
IR tablets |
750 mg/day |
Schizophrenia |
54 |
51 |
|
0% |
8% |
Adults |
IR tablets |
150 mg/day |
Schizophrenia |
48 |
51 |
Neuromuscular & skeletal: Arthralgia (1% to 4%), back pain (1% to 3%), dyskinesia (3% to 4%), dystonic reaction (≤6%) (table 19), limb pain (2%), muscle rigidity (3%), muscle spasm (2% to 3%), myalgia (2%), neck pain (2%), stiffness (children, adolescents: 3%)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
3% |
0% |
Adolescents |
IR tablets |
400 mg |
Schizophrenia |
73 |
75 |
|
0% |
0% |
Adolescents |
IR tablets |
800 mg |
Schizophrenia |
74 |
75 |
|
2% |
0% |
Adults |
XR tablets |
300 mg/day |
Bipolar disorder, depressive episode |
137 |
140 |
|
0.7% |
0% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
6% |
8% |
Adults |
IR tablets |
750 mg/day |
Schizophrenia |
54 |
51 |
|
4% |
8% |
Adults |
IR tablets |
75 mg/day |
Schizophrenia |
53 |
51 |
|
4% |
8% |
Adults |
IR tablets |
150 mg/day |
Schizophrenia |
48 |
51 |
|
4% |
8% |
Adults |
IR tablets |
600 mg/day |
Schizophrenia |
51 |
51 |
|
0% to 3% |
0% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
|
0% |
8% |
Adults |
IR tablets |
300 mg/day |
Schizophrenia |
52 |
51 |
Ophthalmic: Amblyopia (2%), blurred vision (2% to 4%) (table 20)
|
Drug (Quetiapine) |
Placebo |
Population |
Dosage Form |
Dose |
Indication |
Number of Patients (Quetiapine) |
Number of Patients (Placebo) |
|---|---|---|---|---|---|---|---|
|
3% |
0% |
Children & adolescents |
IR tablets |
400 mg/day |
Bipolar mania |
95 |
90 |
|
2% |
0% |
Children & adolescents |
IR tablets |
600 mg/day |
Bipolar mania |
98 |
90 |
|
4% |
2% |
Adults |
IR tablets |
300 to 600 mg/day |
Bipolar disorder, depressive episode |
698 |
347 |
|
2% |
1% |
Adults |
XR tablets |
400 to 800 mg/day |
Bipolar mania |
151 |
160 |
|
2% |
1% |
Adults |
XR tablets |
300 to 800 mg/day |
Schizophrenia |
951 |
319 |
Otic: Otalgia (2%)
Respiratory: Cough (1% to 3%), dyspnea (1% to 3%), epistaxis (adolescents: 3%), nasal congestion (3% to 6%), paranasal sinus congestion (2% to 3%), pharyngitis (4%), rhinitis (3%), sinus headache (2%), sinusitis (2%)
Miscellaneous: Fever (2% to 4%)
<1%: Endocrine & metabolic: Decreased T3 blood level
Frequency not defined:
Cardiovascular: Hypertensive crisis (one case in a child with a history of hypertension)
Nervous system: Falling, suicidal tendencies
Postmarketing:
Cardiovascular: Atrial fibrillation (Ref), atrial flutter (Ref), cardiomyopathy (Ref), myocarditis (Ref), peripheral edema (Ref), prolonged QT interval on ECG (Ref), torsades de pointes (Ref), ventricular arrhythmia (Ref)
Dermatologic: Acute generalized exanthematous pustulosis (Ref), Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Diabetes mellitus (new onset) (Ref), diabetes mellitus with hyperosmolar coma, diabetic ketoacidosis (Ref), hyponatremia (Ref), hypothyroidism (Ref), SIADH (Ref)
Gastrointestinal: Colonic ischemia, fecal incontinence, intestinal obstruction, pancreatitis (Ref)
Genitourinary: Abnormal orgasm (Ref), erectile dysfunction (Ref), nocturia, urinary retention (high-dose therapy) (Ref)
Hematologic & oncologic: Agranulocytosis (Ref), autoimmune hemolytic anemia (Ref), eosinophilia (Ref), leukopenia (Ref), thrombocytopenia (Ref), thrombotic thrombocytopenic purpura (Ref)
Hepatic: Hepatic failure (Ref), hepatic necrosis, hepatitis (Ref)
Hypersensitivity: Anaphylaxis, angioedema (Ref), drug reaction with eosinophilia and systemic symptoms (Ref), hypersensitivity angiitis (Ref)
Nervous system: Aphasia (Ref), choreoathetosis (Ref), cognitive dysfunction (Ref), delirium (Ref), hypothermia (Ref), neuroleptic malignant syndrome (Ref), retrograde amnesia, somnambulism (Ref), suicidal ideation (Ref)
Neuromuscular & skeletal: Hypokinesia (Ref), rhabdomyolysis (Ref), tardive dyskinesia (Ref)
Ophthalmic: Cataract (Ref), intraoperative floppy iris syndrome (Ref), retinopathy (central serous chorioretinopathy) (Ref)
Respiratory: Obstructive sleep apnea (Ref), sleep apnea
Hypersensitivity to quetiapine or any component of the formulation
Disease-related concerns:
• Bariatric surgery: Presurgical assessment of the indication for use, symptoms, and goals of therapy should be documented to enable post surgical assessment. Quetiapine is associated with significant weight gain (increase of ≥7% from baseline) (Alonso-Pedrero 2019; Domecq 2015). Monitor weight closely post operatively and consider changing agent to alternative agent if weight loss goals are not being met.
• Cancer (eg, breast cancer): The clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.
• GI motility: Use with caution in patients with decreased GI motility as anticholinergic effects may exacerbate underlying condition.
• Hepatic impairment: Use with caution in patients with hepatic disease or impairment.
• Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcohol use disorder, or concurrent therapy with medications which may lower seizure threshold. Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors.
• Urinary retention (eg, benign prostatic hyperplasia): Use with caution in patients with urinary retention as anticholinergic effects may exacerbate underlying condition.
Other warnings/precautions:
• Discontinuation of therapy: When discontinuing antipsychotic therapy, gradually taper antipsychotics to avoid physical withdrawal symptoms and rebound symptoms (APA [Keepers 2020]; WFSBP [Hasan 2012]). Withdrawal symptoms may include agitation, alternating feelings of warmth and cold, anxiety, diaphoresis, dyskinesia, GI symptoms, insomnia, irritability, myalgia, paresthesia, psychosis, restlessness, rhinorrhea, tremor, and vertigo (Lambert 2007; Moncrieff 2020). The risk of withdrawal symptoms is highest following abrupt discontinuation of highly anticholinergic or dopaminergic antipsychotics (Cerovecki 2013). Patients with chronic symptoms, repeated relapses, and clear diagnostic features of schizophrenia are at risk for poor outcomes if medications are discontinued (APA [Keepers 2020]).
Pediatric psychiatric disorders are frequently serious mental disorders which present with variable symptoms that do not always match adult diagnostic criteria. Conduct a thorough diagnostic evaluation and carefully consider risks of psychotropic medication before initiation in pediatric patients. Medication therapy for pediatric patients with bipolar disorder and schizophrenia is indicated as part of a total treatment program that frequently includes educational, psychological, and social interventions.
Unlike adults, hypertension (as defined: systolic blood pressure increased by ≥20 mm Hg, diastolic blood pressure increased by ≥10 mm Hg) has been reported in children and adolescent patients occurring at any time during clinical trials; hypertensive crisis was also reported in children with history of hypertension.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as fumarate:
SEROquel: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg
Generic: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, 400 mg
Tablet Extended Release 24 Hour, Oral, as fumarate:
SEROquel XR: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
Generic: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
Yes
Tablet, 24-hour (QUEtiapine Fumarate ER Oral)
50 mg (per each): $8.87 - $15.00
150 mg (per each): $1.25 - $15.93
200 mg (per each): $1.50 - $17.53
300 mg (per each): $1.75 - $22.98
400 mg (per each): $2.29 - $27.01
Tablet, 24-hour (SEROquel XR Oral)
50 mg (per each): $9.85
150 mg (per each): $17.70
200 mg (per each): $19.48
300 mg (per each): $25.54
400 mg (per each): $30.01
Tablets (QUEtiapine Fumarate Oral)
25 mg (per each): $0.35 - $4.00
50 mg (per each): $0.56 - $6.80
100 mg (per each): $0.56 - $6.86
150 mg (per each): $1.78
200 mg (per each): $1.14 - $12.95
300 mg (per each): $16.95 - $17.06
400 mg (per each): $1.68 - $19.93
Tablets (SEROquel Oral)
25 mg (per each): $4.66
50 mg (per each): $7.66
100 mg (per each): $8.00
200 mg (per each): $15.09
300 mg (per each): $19.79
400 mg (per each): $23.26
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as fumarate:
SEROquel: 25 mg, 100 mg, 200 mg, 300 mg
Generic: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg
Tablet Extended Release 24 Hour, Oral, as fumarate:
SEROquel XR: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
Generic: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg
10 mg/mL Oral Suspension
A 10 mg/mL oral suspension may be made using quetiapine fumarate tablets. Crush one 400 mg immediate-release tablet and reduce to a fine powder. Add 2 mL of propylene glycol and mix to form a paste. Add a small amount (2 to 5 mL) of Ora-Blend and mix to a uniform paste; continue mixing while adding Ora-Blend (up to 20 mL total) until a pourable mixture is formed. Transfer to a calibrated plastic amber bottle, rinse mortar with Ora-Blend, and add quantity of Ora-Blend sufficient to make 40 mL. Label "shake well." Stable for 60 days at room temperature or under refrigeration; storage at room temperature preferred (more consistent dissolution of quetiapine in the Ora-Blend).
The following feeding tube recommendations are based upon the best available evidence and clinical expertise. Senior editor panel: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN.
Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.
Oral:
Tablet, immediate release: May be administered with or without food.
Administration via feeding tube:
Gastric (eg, NG, G-tube) or post-pyloric tubes (eg, J-tube): Crush tablet(s) into a fine powder and disperse in 10 to 15 mL purified water immediately prior to administration; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
Dosage form information: Some tablets may be film-coated; administration of film-coated quetiapine tablets via feeding tube may increase the risk of clogging the tube; if used, ensure tablets are sufficiently dispersed prior to administration (Ref).
General guidance: Hold enteral nutrition during quetiapine administration(Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref). Note: Quetiapine is poorly soluble; extra rinsing and/or larger rinse volume may be necessary (Ref).
Tablet, extended release: Administer without food or with a light meal (~300 calories), preferably in the evening. Swallow tablet whole; do not break, crush, or chew.
Administration via feeding tube: NOT recommended: Crushing modified-release dosage forms (eg, extended-release tablets) may result in release of excessive doses, variable serum concentrations, and risk of severe adverse effects (Ref).
Oral:
IR tablet: Administer with or without food.
ER tablet: Administer without food or with a light meal (≤300 calories), preferably in the evening. Swallow tablet whole; do not break, crush, or chew.
Bariatric surgery: Quetiapine has an ER formulation and the release characteristics may be significantly altered in an unknown manner in patients who have undergone bariatric surgery. Providers should determine if the condition being treated can be safely monitored or if a switch to an alternate formulation is necessary (Ref). Quetiapine is also available as an IR formulation.
Enteral feeding tube:
The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN.
Oral tablet, extended release: Enteral feeding tube administration utilizing quetiapine ER tablets is not recommended. Crushing modified-release dosage forms (eg, ER tablets) may result in release of excessive doses, variable serum concentrations, and risk of severe adverse effects (Ref).
Oral tablet, immediate release:
Gastric (eg, NG, G-tube ) or post-pyloric (eg, J-tube) tubes: Crush tablet(s) into a fine powder and disperse in 10 to 15 mL purified water immediately prior to administration; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).
Dosage form information: Some formulations may be film-coated; administration of film-coated quetiapine tablets via feeding tube may increase the risk of clogging the tube; if used, ensure tablets are dispersed sufficiently with an adequate amount of purified water prior to administration (Ref).
General guidance: Hold enteral nutrition during quetiapine administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following administration, rinse container used for preparation with purified water; draw up rinse and administer contents to ensure delivery of entire dose (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 30 mL) and restart enteral nutrition (Ref).
Not e: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.
Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Seroquel: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020639s074lbl.pdf#page=49
Seroquel XR: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022047s048lbl.pdf#page=53
Immediate release (Seroquel): Acute treatment (monotherapy or adjunct to lithium or divalproex) of manic episodes associated with bipolar I disorder (FDA approved in ages ≥10 years and adults); treatment of schizophrenia (FDA approved in ages ≥13 years and adults); acute treatment of depressive episodes associated with bipolar disorder (FDA approved in adults); adjunct therapy for maintenance in bipolar I disorder (FDA approved in adults); has also been used for management of autism and ICU-associated delirium.
Extended release (Seroquel XR): Acute treatment (monotherapy or adjunct to lithium or divalproex) of manic or mixed features episodes associated with bipolar I disorder (FDA approved in ages ≥10 years and adults); treatment of schizophrenia (FDA approved in ages ≥13 years and adults); acute treatment of depressive episodes associated with bipolar disorder (FDA approved in adults); adjunct maintenance therapy to lithium or divalproex of bipolar I disorder (FDA approved in adults); adjunct treatment to antidepressants of major depressive disorder (FDA approved in adults).
QUEtiapine may be confused with OLANZapine
Seroquel may be confused with Desyrel, Seroquel XR, Serzone, SINEquan
Antipsychotics are identified in the Beers Criteria as potentially inappropriate medications to be avoided in patients 65 years and older due to an increased risk of stroke and a greater rate of cognitive decline and mortality in patients with dementia. Evidence also suggests there may be an increased risk of mortality with use independent of dementia. Avoid antipsychotics for behavioral problems associated with dementia or delirium unless alternative nonpharmacologic therapies have failed and patient may harm self or others. In addition, antipsychotics should be used with caution in older adults due to their potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium closely with initiation or dosage adjustments in older adults. Use of antipsychotics may be appropriate for labeled indications including schizophrenia, bipolar disorder, Parkinson disease psychosis, adjunctive therapy in major depressive disorder, or for short-term use as an antiemetic (Beers Criteria [AGS 2023]).
Antipsychotics are identified in the Screening Tool of Older Person's Prescriptions (STOPP) criteria as a potentially inappropriate medication in older adults (≥65 years of age) due to an increased risk of falls. Initiation is not recommended for treatment of sleep disorder. Some disease states of concern include dementia, dysphagia, and coronary, cerebral, or peripheral vascular disease (O’Mahony 2023).
Substrate of CYP2D6 (Minor), CYP3A4 (Major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Acetylcholinesterase Inhibitors: May decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Aclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Acrivastine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Acrivastine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Agents With Seizure Threshold Lowering Potential: May increase adverse/toxic effects of QUEtiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Alcohol (Ethyl): CNS Depressants may increase CNS depressant effects of Alcohol (Ethyl). Risk C: Monitor
Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Amifampridine: Agents With Seizure Threshold Lowering Potential may increase neuroexcitatory and/or seizure-potentiating effects of Amifampridine. Risk C: Monitor
Amisulpride (Oral): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Amisulpride (Oral). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even greater risk. Risk D: Consider Therapy Modification
Anti-Parkinson Agents (Dopamine Agonist): Antipsychotic Agents (Second Generation [Atypical]) may decrease therapeutic effects of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider avoiding atypical antipsychotic use in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). Risk D: Consider Therapy Modification
Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
ARIPiprazole Lauroxil: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of ARIPiprazole Lauroxil. Specifically, the risk of seizures may be increased. Risk C: Monitor
ARIPiprazole: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of ARIPiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor
Armodafinil: May decrease serum concentration of QUEtiapine. Risk C: Monitor
Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification
Asenapine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Asenapine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Azithromycin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Azithromycin (Systemic). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Benperidol: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Benperidol. Risk C: Monitor
Benperidol: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Benperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor
Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Benzgalantamine-Galantamine: May increase neurotoxic (central) effects of Antipsychotic Agents. Risk C: Monitor
Benztropine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Benztropine. Risk C: Monitor
Biperiden: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Biperiden. Risk C: Monitor
Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification
Blood Pressure Lowering Agents: May increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor
Bornaprine: May increase adverse/toxic effects of Antipsychotic Agents. Specifically, tardive dyskinesia symptoms may be potentiated. Risk C: Monitor
Botulinum Toxin-Containing Products: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Brexanolone: CNS Depressants may increase CNS depressant effects of Brexanolone. Risk C: Monitor
Brexpiprazole: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Brexpiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor
Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Bromopride: May increase adverse/toxic effects of Antipsychotic Agents. Risk X: Avoid
Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Buclizine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Buclizine. Risk C: Monitor
Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification
BuPROPion: May increase neuroexcitatory and/or seizure-potentiating effects of Agents With Seizure Threshold Lowering Potential. Risk C: Monitor
BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Cabergoline: May decrease therapeutic effects of Antipsychotic Agents. Risk X: Avoid
Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of Cannabinoid-Containing Products. Risk C: Monitor
Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor
CarBAMazepine: May decrease serum concentration of QUEtiapine. QUEtiapine may increase active metabolite exposure of CarBAMazepine. Management: Quetiapine dose increases to as much as 5 times the regular dose may be required to maintain therapeutic benefit. Reduce the quetiapine dose back to the previous/regular dose within 7 to 14 days of discontinuing carbamazepine. Risk D: Consider Therapy Modification
Carbetocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Cariprazine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Cariprazine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification
Chloral Hydrate/Chloral Betaine: CNS Depressants may increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification
Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification
Chloroquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Chloroquine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor
Chlorprothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Chlorprothixene. Risk C: Monitor
Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Cimetropium. Risk X: Avoid
Citalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Citalopram. Risk X: Avoid
Clarithromycin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clarithromycin. Risk X: Avoid
Clofazimine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Clofazimine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
ClomiPRAMINE: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Clothiapine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Clothiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor
CloZAPine: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider Therapy Modification
CloZAPine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of CloZAPine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
CNS Depressants: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor
Cyclizine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
CYP3A4 Inducers (Moderate): May decrease serum concentration of QUEtiapine. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of QUEtiapine. Management: An increase in quetiapine dose (as much as 5 times the regular dose) may be required to maintain therapeutic benefit. Reduce the quetiapine dose back to the previous/regular dose within 7 to 14 days of discontinuing the inducer. Risk D: Consider Therapy Modification
CYP3A4 Inhibitors (Moderate): May increase serum concentration of QUEtiapine. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase serum concentration of QUEtiapine. Management: In quetiapine treated patients, reduce quetiapine to one-sixth of original dose after starting a strong CYP3A4 inhibitor. In those on strong CYP3A4 inhibitors, start quetiapine at lowest dose and up-titrate as needed. Risk D: Consider Therapy Modification
Dabrafenib: May increase QTc-prolonging effects of QUEtiapine. Dabrafenib may decrease serum concentration of QUEtiapine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and reduced quetiapine efficacy. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Dantrolene: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Daridorexant: May increase CNS depressant effects of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification
Darifenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Darifenacin. Risk C: Monitor
Dasatinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Dasatinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Deutetrabenazine: May increase adverse/toxic effects of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Risk C: Monitor
DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification
Dexmethylphenidate-Methylphenidate: Antipsychotic Agents may increase adverse/toxic effects of Dexmethylphenidate-Methylphenidate. Dexmethylphenidate-Methylphenidate may increase adverse/toxic effects of Antipsychotic Agents. Specifically, the risk of extrapyramidal symptoms may be increased when these agents are combined. Risk C: Monitor
Dicyclomine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Dicyclomine. Risk C: Monitor
Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Difenoxin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor
Dimethindene (Systemic): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Dimethindene (Systemic). Risk C: Monitor
Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Domperidone: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Domperidone. Risk X: Avoid
Donepezil: May increase neurotoxic (central) effects of Antipsychotic Agents. Risk C: Monitor
Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Doxepin-Containing Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Doxepin-Containing Products. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Doxylamine: CNS Depressants may increase CNS depressant effects of Doxylamine. Risk C: Monitor
DroNABinol: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of DroNABinol. Risk X: Avoid
DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification
DroPERidol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of DroPERidol. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Eluxadoline. Risk X: Avoid
Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor
Encorafenib: May increase QTc-prolonging effects of QUEtiapine. Encorafenib may decrease serum concentration of QUEtiapine. Management: An increase in quetiapine dose (as much as 5 times the regular dose) may be required to maintain therapeutic benefit. Additionally, monitor for QTc interval prolongation and ventricular arrhythmias. Risk D: Consider Therapy Modification
Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Entrectinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid
Escitalopram: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Escitalopram. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Esketamine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Etelcalcetide: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Fesoterodine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Fesoterodine. Risk C: Monitor
Fexinidazole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid
Fingolimod: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias (including TdP) with a continuous overnight ECG when fingolimod is combined with QT prolonging drugs. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Flecainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flecainide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Fluconazole: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Fluconazole. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid
Flunitrazepam: CNS Depressants may increase CNS depressant effects of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider Therapy Modification
Fluorouracil Products: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Fluorouracil Products. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Flupentixol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Flupentixol. Risk X: Avoid
FluPHENAZine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of FluPHENAZine. Specifically, the risk of seizures may be increased. Risk C: Monitor
FluPHENAZine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Gadobenate Dimeglumine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Gadobenate Dimeglumine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor
Gemifloxacin: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Gepotidacin: May decrease anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Gilteritinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. If use is necessary, monitor for QTc interval prolongation and arrhythmias. Risk D: Consider Therapy Modification
Glucagon: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor
Glycopyrrolate (Oral Inhalation): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid
Glycopyrrolate (Systemic): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Systemic). Risk C: Monitor
Glycopyrronium (Topical): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Grapefruit Juice: May increase serum concentration of QUEtiapine. Risk C: Monitor
Guanethidine: Antipsychotic Agents may decrease therapeutic effects of Guanethidine. Risk C: Monitor
Halofantrine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Halofantrine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Haloperidol: QT-prolonging Miscellaneous Agents (Highest Risk) may increase QTc-prolonging effects of Haloperidol. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Huperzine A: May increase neurotoxic (central) effects of Antipsychotic Agents. Risk C: Monitor
HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification
Iloperidone: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Iloperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor
Imipramine: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Inotuzumab Ozogamicin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Inotuzumab Ozogamicin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Iohexol: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider Therapy Modification
Iomeprol: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider Therapy Modification
Iopamidol: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider Therapy Modification
Ipratropium (Nasal): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ipratropium (Oral Inhalation): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Itopride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Itopride. Risk C: Monitor
Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Kratom: May increase CNS depressant effects of QUEtiapine. Kratom may increase serum concentration of QUEtiapine. Risk X: Avoid
LamoTRIgine: May increase CNS depressant effects of QUEtiapine. LamoTRIgine may decrease serum concentration of QUEtiapine. Risk C: Monitor
Lefamulin: May increase QTc-prolonging effects of QT-prolonging CYP3A4 Substrates. Management: Do not use lefamulin tablets with QT-prolonging CYP3A4 substrates. Lefamulin prescribing information lists this combination as contraindicated. Risk X: Avoid
Lemborexant: May increase CNS depressant effects of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider Therapy Modification
Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Levofloxacin-Containing Products (Systemic): May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Levoketoconazole: QT-prolonging CYP3A4 Substrates may increase QTc-prolonging effects of Levoketoconazole. Levoketoconazole may increase serum concentration of QT-prolonging CYP3A4 Substrates. Risk X: Avoid
Levosulpiride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Levosulpiride. Risk X: Avoid
Lithium: May increase neurotoxic effects of Antipsychotic Agents. Lithium may decrease serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Risk C: Monitor
Lofepramine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Lofexidine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Lofexidine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Lonafarnib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification
Lumateperone: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Lumateperone. Specifically, the risk of seizures may be increased. Risk C: Monitor
Lurasidone: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Lurasidone. Specifically, the risk of seizures may be increased. Risk C: Monitor
Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Maprotiline: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Maprotiline. Risk C: Monitor
Meglumine Antimoniate: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Melitracen [INT]: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Melperone: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Metergoline: Antipsychotic Agents may decrease therapeutic effects of Metergoline. Metergoline may decrease therapeutic effects of Antipsychotic Agents. Risk C: Monitor
Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification
Methoxyflurane: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Methscopolamine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Methscopolamine. Risk C: Monitor
Metoclopramide: May increase adverse/toxic effects of Antipsychotic Agents. Risk X: Avoid
MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor
MetyroSINE: May increase adverse/toxic effects of Antipsychotic Agents. Specifically, the risk for extrapyramidal symptoms and excessive sedation may be increased. Risk C: Monitor
Midostaurin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Midostaurin. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Mirabegron: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Mirabegron. Risk C: Monitor
Molindone: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Molindone. Specifically, the risk of seizures may be increased. Risk C: Monitor
Moxifloxacin (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Moxifloxacin (Systemic). Risk X: Avoid
Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Nalfurafine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Nilotinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Nilotinib. Risk X: Avoid
Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects may decrease absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor
Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid
OLANZapine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of OLANZapine. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Ondansetron: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ondansetron. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification
Opipramol: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid
Osimertinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Osimertinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Oxatomide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid
Oxybate Salt Products: CNS Depressants may increase CNS depressant effects of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider Therapy Modification
OxyBUTYnin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of OxyBUTYnin. Risk C: Monitor
OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification
Oxytocin: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Pacritinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pacritinib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
Paliperidone: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Paliperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor
Paliperidone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid
PAZOPanib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of PAZOPanib. Risk X: Avoid
Pentamidine (Systemic): QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pentamidine (Systemic). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Perampanel: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Perazine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Periciazine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Periciazine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Perphenazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Perphenazine. Risk C: Monitor
Perphenazine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Perphenazine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Pilsicainide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pilsicainide. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Pimozide: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Pimozide. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk X: Avoid
Pipamperone: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Pipamperone. Specifically, the risk of seizures may be increased. Risk X: Avoid
Piperaquine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Piperaquine. Risk X: Avoid
Piribedil: Antipsychotic Agents may decrease therapeutic effects of Piribedil. Piribedil may decrease therapeutic effects of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Risk X: Avoid
Pizotifen: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Polyethylene Glycol-Electrolyte Solution: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Polyethylene Glycol-Electrolyte Solution. Specifically, the risk of seizure may be increased. Risk C: Monitor
Posaconazole: May increase serum concentration of QT-prolonging CYP3A4 Substrates. Such increases may lead to a greater risk for proarrhythmic effects and other similar toxicities. Risk X: Avoid
Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid
Potassium Citrate: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid
Pramlintide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid
Probucol: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Probucol. Risk X: Avoid
Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Prochlorperazine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Prochlorperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Promazine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Promazine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Promethazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Promethazine. Risk C: Monitor
Propafenone: May increase QTc-prolonging effects of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Propantheline: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Propantheline. Risk C: Monitor
Propiverine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Propofol: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
QT-prolonging Agents (Highest Risk): May increase QTc-prolonging effects of QUEtiapine. Risk X: Avoid
QT-prolonging Agents (Indeterminate Risk - Avoid): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-prolonging Agents (Indeterminate Risk - Caution): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor
QT-Prolonging Inhalational Anesthetics (Moderate Risk): May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May increase QTc-prolonging effects of QUEtiapine. QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of QUEtiapine. Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation, ventricular arrhythmias, and other quetiapine toxicities. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): May increase QTc-prolonging effects of QUEtiapine. QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk) may increase serum concentration of QUEtiapine. Risk X: Avoid
QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): QUEtiapine may increase QTc-prolonging effects of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk) may increase serum concentration of QUEtiapine. Management: Reduce the quetiapine dose to one-sixth of the regular dose when initiating these strong CYP3A4 inhibitors. In patients already receiving these strong CYP3A4 inhibitors, initiate quetiapine at the lowest dose and titrate cautiously as needed. Risk D: Consider Therapy Modification
Quinagolide: Antipsychotic Agents may decrease therapeutic effects of Quinagolide. Risk C: Monitor
Quizartinib: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Ramosetron. Risk C: Monitor
Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Revefenacin. Risk X: Avoid
Ribociclib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Ribociclib. Risk X: Avoid
Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
RisperiDONE: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of RisperiDONE. QT-prolonging Agents (Highest Risk) may increase CNS depressant effects of RisperiDONE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider Therapy Modification
Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Rivastigmine. Rivastigmine may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider Therapy Modification
Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification
Scopolamine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Scopolamine. Risk C: Monitor
Secretin: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider Therapy Modification
Serotonergic Agents (High Risk): May increase adverse/toxic effects of Antipsychotic Agents. Specifically, serotonergic agents may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may increase serotonergic effects of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Risk C: Monitor
Sertindole: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Risk X: Avoid
Sodium Phosphates: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Sodium Phosphates. Specifically, the risk of seizure or loss of consciousness may be increased in patients with significant sodium phosphate-induced fluid or electrolyte abnormalities. Risk C: Monitor
Sofpironium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Sofpironium. Risk X: Avoid
Sparfloxacin: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Sparfloxacin. Risk X: Avoid
St John's Wort: May decrease serum concentration of QUEtiapine. Management: Quetiapine dose increases to as much as 5 times the regular dose may be required to maintain therapeutic benefit. Reduce the quetiapine dose back to the previous/regular dose within 7 to 14 days of discontinuing St John's wort. Monitor closely. Risk D: Consider Therapy Modification
Sulpiride: Antipsychotic Agents may increase adverse/toxic effects of Sulpiride. Risk X: Avoid
SUNItinib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of SUNItinib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Suvorexant: CNS Depressants may increase CNS depressant effects of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification
Terbutaline: May increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Tetrabenazine: May increase adverse/toxic effects of Antipsychotic Agents. Specifically, the risk for NMS and extrapyramidal symptoms may be increased. Risk C: Monitor
Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid
Thiazide and Thiazide-Like Diuretics: Agents with Clinically Relevant Anticholinergic Effects may increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Thioridazine: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Thioridazine. Risk X: Avoid
Thiothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Thiothixene. Risk C: Monitor
Thiothixene: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Thiothixene. Specifically, the risk of seizures may be increased. Risk C: Monitor
Tiapride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Tiapride. Risk C: Monitor
Tiotropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tiotropium. Risk X: Avoid
Tolterodine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tolterodine. Risk C: Monitor
Topiramate: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Topiramate. Risk C: Monitor
Toremifene: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Toremifene. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Trifluoperazine: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Trifluoperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor
Trimeprazine: QUEtiapine may increase CNS depressant effects of Trimeprazine. Trimeprazine may increase serum concentration of QUEtiapine. Risk C: Monitor
Trimethobenzamide: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trimethobenzamide. Risk C: Monitor
Trospium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trospium. Risk C: Monitor
Umeclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor
Vemurafenib: QT-prolonging Agents (Highest Risk) may increase QTc-prolonging effects of Vemurafenib. Management: Consider alternatives to this combination. Patients with other risk factors (eg, older age, female sex, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations) are likely at greater risk for these toxicities. Risk D: Consider Therapy Modification
Warfarin: QUEtiapine may increase anticoagulant effects of Warfarin. Risk C: Monitor
Zolpidem: CNS Depressants may increase CNS depressant effects of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider Therapy Modification
Zuclopenthixol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Zuclopenthixol. Risk C: Monitor
Zuclopenthixol: Agents With Seizure Threshold Lowering Potential may increase adverse/toxic effects of Zuclopenthixol. Specifically, the risk of seizures may be increased. Risk C: Monitor
Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification
In healthy volunteers, administration of quetiapine (immediate release) with food resulted in an increase in the peak serum concentration and AUC by 25% and 15%, respectively, compared to the fasting state. Administration of the extended-release formulation with a high-fat meal (~800-1000 calories) resulted in an increase in peak serum concentration by 44% to 52% and AUC by 20% to 22% for the 50 mg and 300 mg tablets; administration with a light meal (≤300 calories) had no significant effect on the Cmax or AUC. Management: Administer without food or with a light meal (≤300 calories).
Administer extended-release tablet without food or with a light meal (≤300 calories).
Evaluate pregnancy status and provide preconception counseling prior to initiating treatment in patients who could become pregnant (APA [Keepers 2020]; BAP [McAllister-Williams 2017]; CANMAT [Yatham 2018]). Patients effectively treated may continue their current antipsychotic medication when planning a pregnancy unless contraindications exist (ACOG 2023; BAP [McAllister-Williams 2017]); the lowest effective dose and avoidance of polytherapy is recommended (BAP [Barnes 2020]; BAP [McAllister-Williams 2017]; CANMAT [Yatham 2018]). Management of mental health conditions in patients who could become pregnant should be based on a shared decision-making process that considers the possibility of pregnancy during treatment and the risks of discontinuing antipsychotic therapy (ACOG 2023; BAP [McAllister-Williams 2017]; CANMAT [Yatham 2018]).
Antipsychotic agents may be associated with sexual dysfunction. Some second generation (atypical) antipsychotics (SGAs) may cause hyperprolactinemia, resulting in menstrual disorders or impaired spermatogenesis. Consider changing to a medication that is prolactin-sparing, such as quetiapine, in patients with clinical symptoms. Contraception should be provided if pregnancy is not desired as unintended pregnancies may occur when changing to a prolactin-sparing medication (APA [Keepers 2020]; BAP [McAllister-Williams 2017]).
Quetiapine crosses the placenta and is detected in cord blood (Newport 2007; Schoretsanitis 2020).
Outcome data following exposure to second generation (atypical) antipsychotics (SGAs) as a class do not show a significant increased risk of major congenital malformations (BAP [Barnes 2020]); however, specific outcomes vary due to differences in study design (BAP [McAllister-Williams 2017]; Cohen 2018; Cohen 2023; Ellfolk 2021; Ennis 2015; Huybrechts 2023; Terrana 2015; Wang 2021). Although quetiapine is one of the SGAs with the most first trimester exposure data (BAP [McAllister-Williams 2017]), additional studies are needed for individual agents and specific outcomes (BAP [Barnes 2020]). Data related to the long-term effects of in utero antipsychotic exposure on infant neurodevelopment and behavior are limited (BAP [McAllister-Williams 2017]; Straub 2022; Swetlik 2024).
Antipsychotic use during the third trimester of pregnancy increases the risk for extrapyramidal symptoms and/or withdrawal symptoms in newborns following delivery (Viguera 2023). Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor. These effects may require prolonged hospitalization or resolve within hour or days without specific treatment. Tapering the dose late in pregnancy to reduce the risk of symptoms is not recommended (APA [Keepers 2020]).
Atypical antipsychotics are associated with metabolic changes and the risk varies by specific agent. Available studies that evaluated the risk of developing gestational diabetes mellitus (GDM) during antipsychotic therapy have conflicting results, possibly due to differences in study design (ACOG 2023; Uguz 2019). Pregnant patients with diabetes mellitus or GDM may continue antipsychotic treatment (ACOG 2023). Consider the metabolic risks of the specific antipsychotic if treatment is initiated for the first time during pregnancy. High-risk metabolic SGAs include quetiapine, which is associated with higher risk for GDM and infants born LGA than those that are nonexposed (Heinonen 2022; Park 2018). Screening for GDM should continue as part of standard prenatal care; early screening is not needed due to psychiatric medication exposure (ACOG 2023; BAP [McAllister-Williams 2017]).
Due to pregnancy-induced physiologic changes some pharmacokinetic properties of quetiapine may be altered. Quetiapine serum concentrations may decrease as pregnancy progresses due to changes in CYP3A4 metabolism and dosage adjustments may be required in some patients (Badhan 2020; Pinheiro 2018; Westin 2018; Zheng 2021).
Untreated and undertreated mental health conditions are associated with adverse pregnancy outcomes (ACOG 2023). Adverse obstetric and neonatal outcomes are associated with schizophrenia; however, comparisons between treated and untreated pregnancies are limited (BAP [McAllister-Williams 2017]). Untreated bipolar disorder is associated with fetal growth restriction, preterm birth, and adverse neurodevelopment, and may increase the risk of postpartum psychosis, worsening mood, and postpartum hospitalization. Untreated or undertreated depression is associated with preterm birth, LBW, preeclampsia, postpartum depression, and impaired infant attachment (associated with long-term developmental effects). Discontinuing effective medications during pregnancy increases the risk of symptom relapse (ACOG 2023).
Patients effectively treated for schizophrenia or bipolar disorder pre-pregnancy may use the same medication during pregnancy unless contraindications exist (ACOG 2023; APA [Keeper 2020]). SGAs are better tolerated than first-generation (typical) antipsychotics (ACOG 2023). Quetiapine has a relatively low placental transfer and may be the preferred SGA in pregnant patients requiring medication for bipolar disorder who are treatment naive or who do not have a history of effective treatment in the past (ACOG 2023). SGAs are not considered a first-line medication for depression in pregnant patients who are treatment naive or who do not have a history of effective treatment in the past (ACOG 2023; BAP [McAllister-Williams 2017]). Long acting/depot preparations should not be initiated during pregnancy, but may be continued when the risk of recurrence is high (BAP [Barnes 2020]).
Management of mental health conditions should be made as part of a shared decision-making process (ACOG 2023; BAP [McAllister-Williams 2017]). Treatment should not be withheld or discontinued based only on pregnancy status. When medications are used, the lowest effective dose of a single agent is recommended. Optimize dosing prior to changing a medication or adding additional agents whenever possible. Close monitoring for symptom improvement with a validated screening tool during pregnancy is recommended. Manage side effects as needed (ACOG 2023).
Data collection to monitor pregnancy and infant outcomes following exposure to psychiatric medications is ongoing. Encourage pregnant patients 45 years of age and younger with a history of psychiatric illness to enroll in the National Pregnancy Registry for Psychiatric Mediations (1-866-961-2388 or https://womensmentalhealth.org/research/pregnancyregistry/).
Vital signs, including for children and adolescents, BP at baseline and periodically; CBC with differential; fasting lipid profile and fasting blood glucose/HbA1c (prior to treatment, at 3 months, then annually); weight, growth, BMI, and waist circumference (especially in children), personal/family history of diabetes, BP, mental status, abnormal involuntary movement scale (AIMS), extrapyramidal symptoms (EPS). In adults, weight should be assessed prior to treatment, at 4 weeks, 8 weeks, 12 weeks, and then at quarterly intervals; consider titrating to a different antipsychotic agent for a weight gain ≥5% of the initial weight. Monitor patient periodically for symptom resolution; monitor for worsening depression, suicidality, and associated behaviors (especially at the beginning of therapy or when doses are increased or decreased). Patients should have eyes checked for cataracts every 6 months while on this medication.
Measure both thyroid stimulating hormone (TSH) and free T4, along with clinical assessment, at baseline and follow-up to determine thyroid status; measurement of TSH alone may not be accurate; the exact mechanism of the effect of quetiapine on the thyroid axis is unknown.
ICU-associated delirium: ECG (baseline, 48 hours of therapy, and periodically as needed).
Quetiapine is a dibenzothiazepine atypical antipsychotic. It has been proposed that this drug's antipsychotic activity is mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5-HT2) antagonism. It is an antagonist at multiple neurotransmitter receptors in the brain: Serotonin 5-HT1A and 5-HT2, dopamine D1 and D2, histamine H1, and adrenergic alpha1- and alpha2-receptors; but appears to have no appreciable affinity at cholinergic muscarinic and benzodiazepine receptors. Norquetiapine, an active metabolite, differs from its parent molecule by exhibiting high affinity for muscarinic M1 receptors.
Antagonism at receptors other than dopamine and 5-HT2 with similar receptor affinities may explain some of the other effects of quetiapine. The drug's antagonism of histamine H1-receptors may explain the somnolence observed. The drug's antagonism of adrenergic alpha1-receptors may explain the orthostatic hypotension observed.
Onset of action:
Bipolar disorder, acute mania: Initial effects may be observed within days of treatment with continued improvements over 1 to 2 weeks (Goikolea 2013; Tohen 2000; Welten 2016).
Bipolar disorder, depressive episode: Initial effects may be observed within 1 week of treatment with continued improvements through 6 weeks (Cruz 2010).
Generalized anxiety disorder: Extended release: Initial effects may be observed within 4 to 7 days with continued improvements over 8 weeks (Bandelow 2010; Khan 2011; Merideth 2012).
Major depressive disorder, unipolar: Initial effects may be observed within 1 week with continued improvements over 6 to 12 weeks (Wen 2014).
Schizophrenia: Oral: Initial effects may be observed within 1 to 2 weeks of treatment with continued improvements through 4 to 6 weeks (Agid 2003; Levine 2010).
Absorption: Rapidly absorbed following oral administration; high-fat meals (800 to 1,000 calories) increased exposure to quetiapine XR; light meals (~300 calories) have no effect. Parent compound AUC and Cmax were 41% and 39% lower, respectively, in pediatric patients (10 to 17 years) compared to adults when adjusted for weight, but pharmacokinetics of active metabolite were similar to adult values after adjusting for weight.
Distribution: Vd: 10 ± 4 L/kg
Protein binding, plasma: 83%
Metabolism: Primarily hepatic; via CYP3A4; forms the metabolite norquetiapine (ie, N-desalkyl quetiapine) (active) and two inactive metabolites [sulfoxide metabolite (major metabolite) and parent acid metabolite]
Bioavailability: 100% (relative to oral solution)
Half-life elimination:
Children and adolescents 12 to 17 years: Quetiapine: 5.3 hours (McConville 2000).
Adults:
IR or ER quetiapine: Mean terminal t1/2: ~6 to 7 hours.
Norquetiapine (ie, N-desalkyl quetiapine) (active metabolite): 12 hours.
Time to peak, plasma:
Children and Adolescents 12 to 17 years: Immediate release: 0.5 to 3 hours (McConville 2000)
Adults: Immediate release: 1.5 hours; Extended release: 6 hours
Excretion: Urine (73% as metabolites, <1% of total dose as unchanged drug); feces (20%)
Altered kidney function: CrCl 10 to 30 mL/minute had 25% lower clearance; plasma concentrations were within the range of concentrations seen in normal subjects.
Hepatic function impairment: 30% lower clearance; AUC and Cmax is 3-fold higher.
Older adult: Clearance reduced 40%.
