Hydroxyzine: Drug information

For additional information see "Hydroxyzine: Patient drug information" and "Hydroxyzine: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Vistaril

Brand Names: Canada

Atarax;
NOVO-Hydroxyzin;
PMS-HydrOXYzine HCl [DSC]

Pharmacologic Category

Antiemetic;
Histamine H₁ Antagonist;
Histamine H₁ Antagonist, First Generation;
Piperazine Derivative

Dosing: Adult

Anxiety, monotherapy or adjunctive therapy

Anxiety, monotherapy or adjunctive therapy (alternative agent):

Note: May be useful for insomnia associated with anxiety or for short-term immediate control of symptoms until maintenance therapy is effective (Ref).

Oral: Usual dosage range: 25 to 50 mg up to 4 times daily, as needed; may increase based on response and tolerability up to 400 mg/day; maximum single dose: 100 mg. For insomnia associated with anxiety, administer at bedtime (Ref).

Peripartum management, adjunct to opioids

Peripartum management, adjunct to opioids:

Note: May be used to potentiate opioid analgesia and decrease side effects (eg, nausea and vomiting).

IM: 25 to 50 mg as a single dose; may repeat after 4 hours if needed (Ref).

Pruritus

Pruritus:

Note: Reduced doses should be considered in kidney impairment. For patients with uremic pruritus, see “Dosing: Altered Kidney Function: Adult.”

Manufacturer’s dosing: Oral: 25 mg 3 to 4 times daily as needed.

Nightly dosing: Oral: Due to its sedating properties, some experts recommend 25 to 50 mg once daily as needed at bedtime (Ref).

Urticaria, new onset and chronic spontaneous

Urticaria, new onset and chronic spontaneous (alternative agent):

Note: Second-generation H₁-antihistamines are preferred due to less sedating and anticholinergic effects (Ref). May consider use in combination with a second-generation H₁-antihistamine in patients in whom bedtime sedating effects may be beneficial, or as initial parenteral therapy in patients with new-onset urticaria in whom more rapid onset of action is desired; avoid use in patients with high-risk occupations (eg, pilots, bus drivers) or who may be more prone to anticholinergic effects (eg, older adults) (Ref).

Oral: Initial: 10 to 25 mg at bedtime. May increase in 10 to 25 mg increments at weekly intervals if needed based on response and tolerability; daily dose may be administered at bedtime or in 3 to 4 divided doses (Ref). Some experts administer daily doses >100 mg in divided doses; do not exceed 200 mg/day (Ref).

IM (for new onset urticaria only): 25 to 50 mg 3 to 4 times per day as needed (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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.

Note: There are no data on hydroxyzine pharmacokinetics in kidney impairment; however, the active metabolite, cetirizine, is cleared by the kidney and may accumulate in patients with kidney impairment (Ref). Additionally, hydroxyzine was associated with QTc prolongation in a cohort of patients with chronic kidney insufficiency (Ref).

Altered kidney function:

Oral, IM:

CrCl ≥50 mL/minute: No dosage adjustment necessary (Ref).

CrCl 10 to <50 mL/minute: Administer ~50% of usual dose (Ref).

CrCl <10 mL/minute: Administer ~25% to 50% of usual dose (Ref).

Hemodialysis, intermittent (thrice weekly): Hydroxyzine is unlikely to be significantly dialyzed (large V_d (Ref)) and its metabolite (cetirizine) is <10% dialyzable (Ref):

Oral, IM: Administer 25% to 50% of usual dose (Ref).

Uremic pruritus: Oral: 10 to 25 mg once or twice daily as needed (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (large V_d) (Ref):

Oral, IM: Administer 25 to 50% of usual dose (Ref).

Uremic pruritus: Oral: 10 to 25 mg once or twice daily as needed (Ref).

CRRT: Oral, IM: Administer 50% of usual dose (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Oral, IM: Administer 50% of usual dose (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. In patients with primary biliary cirrhosis, change dosing interval to every 24 hours (Ref).

Dosing: Older Adult

Avoid use (Ref).

Dosing: Pediatric

(For additional information see "Hydroxyzine: Pediatric drug information")

Antiemetic

Antiemetic: Note: Expert recommendations for postoperative nausea and vomiting (PONV) management do not suggest hydroxyzine as a therapeutic option; use has typically been replaced by newer agents with an improved safety profile (Ref).

Infants, Children, and Adolescents: IM: 1.1 mg/kg/dose; maximum dose: 100 mg/dose.

Anxiety

Anxiety: Note: Although FDA approved for use in anxiety, data in pediatric patients are sparse; expert recommendations for pediatric patients do not consider hydroxyzine a therapeutic option for the management of anxiety disorders (eg, generalized anxiety disorder, separation anxiety, specific phobias, panic disorder, post-traumatic stress disorder); use has generally been replaced by newer, more effective agents (Ref). In adults, a lower daily dosing regimen of 37.5 to 75 mg/day in divided doses is recommended by experts (Ref).

Children <6 years: Oral: 12.5 mg 4 times daily (Ref); although FDA approved, expert guidelines do not recommend pharmacotherapy in patients <6 years of age (Ref).

Children ≥6 years and Adolescents: Oral: 12.5 to 25 mg 4 times daily (Ref).

Pruritus; associated with allergic conditions or chronic urticaria

Pruritus; associated with allergic conditions or chronic urticaria:

Age-directed dosing:

Children <6 years: Oral: 12.5 mg 3 to 4 times daily (Ref).

Children ≥6 years and Adolescents: Oral: 12.5 to 25 mg 3 to 4 times daily (Ref). Note: Based on pharmacokinetic studies, dosing once daily (at bedtime) or twice daily may be adequate due to the long half-life (Ref).

Weight-directed dosing:

Children and Adolescents:

Patient weight ≤40 kg: Oral: 2 mg/kg/day divided every 6 to 8 hours as needed; maximum dose: 25 mg/dose. Note: Based on pharmacokinetic studies, dosing once daily (at bedtime) or twice daily may be adequate due to the long half-life (Ref).

Patient weight >40 kg: Oral: 25 to 50 mg once daily at bedtime or twice daily (Ref).

Pruritus; associated with opioid use

Pruritus; associated with opioid use: Limited data available: Children and Adolescents: IM, Oral: 0.5 mg/kg/dose every 6 hours as needed; usual maximum dose: 50 mg/dose (Ref).

Sedation; pre-/postoperative, adjunctive therapy

Sedation; pre-/postoperative, adjunctive therapy: Note: Although FDA approved, pre-/postoperative hydroxyzine use has largely been replaced by other agents.

Oral: Children and Adolescents: Oral: 0.6 mg/kg/dose; maximum dose: 100 mg/dose.

IM: Infants, Children, and Adolescents: IM: 1.1 mg/kg/dose; maximum dose: 100 mg/dose.

Sedation; procedural, adjunctive therapy

Sedation; procedural, adjunctive therapy (eg, dental, echocardiography): Limited data available:

Children 2 to 12 years: Oral: 1 mg/kg/dose as a single dose 30 to 45 minutes prior to procedure in combination with other sedatives (eg, midazolam, chloral hydrate) has been used in children prior to dental procedures or echocardiograms; maximum dose: 100 mg/dose (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Altered kidney function:

Note: There are no data on hydroxyzine pharmacokinetics in kidney impairment; however, based on adult data, the active metabolite, cetirizine, is cleared by the kidney and may accumulate in patients with kidney impairment (Ref). Additionally, hydroxyzine was associated with QTc prolongation in a cohort of adult patients with chronic kidney insufficiency (Ref).

Children and Adolescents: Oral, IM:

Mild impairment: No dosage adjustment necessary (Ref).

Moderate to severe impairment: Administer ~50% of usual dose (Ref).

Hemodialysis, intermittent: Hydroxyzine is unlikely to be significantly dialyzed (due to large V_d (Ref)) and its metabolite (cetirizine) is <10% dialyzable (Ref).

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations; based on experience in adults with primary biliary cirrhosis, increasing length of dosing interval is recommended (Ref).

Adverse Reactions (Significant): Considerations

Acute generalized exanthematous pustulosis

Acute generalized exanthematous pustulosis (AGEP) has rarely been reported (Ref). Resolution generally occurs 2 weeks after drug discontinuation (Ref); although, with hydroxyzine, may occur within 3 days (Ref).

Mechanism: Non–dose-related; immunologic. AGEP is considered a T-cell mediated reaction (Ref).

Onset: Delayed: usually within 24 hours after drug initiation (Ref).

Risk factors:

• Cross-sensitivity: Not established; conflicting evidence regarding cross-reactivity between hydroxyzine, cetirizine, and levocetirizine (Ref)

CNS depression

Drowsiness and dizziness may occur, especially after initial doses. These effects may persist the next morning after bedtime dosing causing daytime drowsiness (Ref). Drowsiness is usually transient and subsides after a few consecutive days of therapy or after dose reduction (Ref). Cognitive dysfunction has been reported after morning and evening dosing, which may impair the ability to drive or operate machinery (Ref). At recommended doses, clinically significant respiratory depression has not been observed.

Mechanism : Dose related; related to the pharmacologic action (ie, competitive binding to histamine-₁ receptors in the CNS) (Ref).

Onset: Rapid; occurs within the first few days of therapy initiation (Ref)

Risk factors:

• Dose (especially initiation) (Ref)

• Concurrent use of other CNS depressant medications

• Concurrent use of alcohol (Ref)

• Age >65 years (Ref)

QT prolongation

Hydroxyzine is associated with a conditional risk of prolonged QT interval on ECG, defined as a QTc >500 msec (Ref). Hydroxyzine-related QT prolongation and torsades de pointes (TdP) have been described in case reports (Ref). QTc values return to normal within days to weeks after drug discontinuation (Ref).

Mechanism: Human ether-à-go-go (hERG) channel inhibition leading to prolongation of the cardiac action potential (Ref).

Onset: Rapid; typically occurs within 5 days after initial dose (Ref).

Risk factors:

Drug-induced QTc prolongation/TdP (in general):

• Females (Ref)

• Age >65 years (Ref)

• Structural heart disease (eg, history of myocardial infarction or heart failure with reduced ejection fraction) (Ref)

• Genetic defects of cardiac ion channels (Ref)

• History of drug-induced TdP (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, hypocalcemia, hypokalemia, hypomagnesemia) (Ref)

• Bradycardia (Ref)

• Hepatic impairment (Ref)

• Kidney impairment (Ref)

• Diuretic use (Ref)

• Sepsis (Ref)

• Concurrent administration of multiple medications (≥2) that prolong the QT interval or medications with drug interactions that increase serum concentrations of QT-prolonging medications (Ref)

Drug-specific:

• hERG gene mutation (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined:

Gastrointestinal: Xerostomia

Nervous system: Drowsiness (transient)

Respiratory: Respiratory depression (high doses)

Postmarketing:

Cardiovascular: Prolonged QT interval on ECG (rare: <1%) (Ref), torsades de pointes (rare: <1%) (Ref)

Dermatologic: Acute generalized exanthematous pustulosis (rare: <1%) (Ref), pruritus, skin rash, urticaria

Hypersensitivity: Fixed drug eruption (Ref)

Nervous system: Cognitive dysfunction (Ref), hallucination, headache, involuntary body movements, seizure (high doses)

Neuromuscular & skeletal: Tremor (high doses)

Contraindications

Hypersensitivity to hydroxyzine or any component of the formulation; early pregnancy; prolonged QT interval.

Additional contraindications:

Oral: Hypersensitivity to cetirizine or levocetirizine.

Injection: SUBQ, intra-arterial, or IV administration.

Canadian labeling: Additional contraindications (not in US labeling): Oral: Hypersensitivity to other piperazine derivatives, aminophylline or ethylenediamine; history of torsade de pointes, including congenital long QT syndromes; history of cardiac arrhythmias; significant electrolyte imbalance (eg, hypokalemia, hypomagnesemia); significant bradycardia; family history of sudden cardiac death; concomitant use with other QT/QTc-prolonging drugs or with CYP3A4/5 inhibitors; asthmatics who have previously experienced a serious anti-histamine induced adverse bronchopulmonary effect; porphyria; patients of childbearing potential.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• QT prolongation/torsades de pointes: Oral hydroxyzine is contraindicated in patients with a prolonged QT interval.

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade. Screening is recommended.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

• Respiratory disease: Use with caution in patients with asthma or chronic obstructive pulmonary disease (COPD).

Special populations:

Older adult: May cause over sedation in older adults; avoid use.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

Other warnings/precautions:

• Appropriate administration: Parenteral: For IM use only. Severe injection-site reactions have been reported with IM administration (eg, extensive tissue damage, necrosis, gangrene) requiring surgical intervention (including debridement, skin grafting, and amputation). SUBQ, IV, and intra-arterial routes of administration are contraindicated. Intravascular hemolysis, thrombosis, and digital gangrene have been reported with IV or intra-arterial administration (Baumgartner 1979); SUBQ administration may result in significant tissue damage. If inadvertent IV administration results in extravasation, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity.

• Long-term use: The effectiveness of hydroxyzine for long-term use (>4 months) has not been assessed; periodically reassess use.

Warnings: Additional Pediatric Considerations

Neonatal withdrawal symptoms, including seizures, have been reported following long-term maternal use or the use of large doses near term (Serreau 2005).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as pamoate:

Vistaril: 25 mg, 50 mg [DSC]

Generic: 25 mg, 50 mg, 100 mg

Solution, Intramuscular, as hydrochloride:

Generic: 25 mg/mL (1 mL); 50 mg/mL (1 mL, 2 mL)

Syrup, Oral, as hydrochloride:

Generic: 10 mg/5 mL (25 mL [DSC], 118 mL, 473 mL)

Tablet, Oral, as hydrochloride:

Generic: 10 mg, 25 mg, 50 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (hydrOXYzine Pamoate Oral)

25 mg (per each): $0.21 - $0.57

50 mg (per each): $0.22 - $0.61

100 mg (per each): $1.19

Capsules (Vistaril Oral)

25 mg (per each): $0.22

Solution (hydrOXYzine HCl Intramuscular)

25 mg/mL (per mL): $32.15

50 mg/mL (per mL): $35.45

Syrup (hydrOXYzine HCl Oral)

10 mg/5 mL (per mL): $0.16 - $1.27

Tablets (hydrOXYzine HCl Oral)

10 mg (per each): $0.11 - $5.34

25 mg (per each): $0.12 - $5.64

50 mg (per each): $0.17 - $5.94

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Generic: 10 mg, 25 mg, 50 mg

Solution, Intramuscular, as hydrochloride:

Generic: 50 mg/mL (1 mL)

Syrup, Oral, as hydrochloride:

Atarax: 10 mg/5 mL (473 mL) [contains alcohol, usp, menthol, sodium benzoate]

Generic: 10 mg/5 mL ([DSC])

Administration: Adult

IM: For IM use only. Aspirate before injection to avoid inadvertent injection into a blood vessel. Do NOT administer IV, SUBQ, or intra-arterially (contraindicated). Administer IM deep in large muscle. The preferred site is the upper outer quadrant of the buttock or midlateral thigh. The upper outer quadrant of the gluteal region should be used only when necessary to minimize potential damage to the sciatic nerve. The deltoid region should be only used with caution to avoid radial nerve injury. Injections should not be made in the lower or mid-third of the upper arm.

Oral: Administer without regard to food.

Administration: Pediatric

Oral: May be administered without regard to food.

Parenteral: For IM use only. SUBQ, intra-arterial, and IV administration are contraindicated and not recommended under any circumstances; intravascular hemolysis, thrombosis, and digital gangrene can occur; extravasation can result in sterile abscess and marked tissue induration (Ref).

Administer IM deep in large muscle. For IM administration in children, injections should be made into the midlateral muscles of the thigh. In infants and children, the upper outer quadrant of the gluteal region should be used only when necessary (eg, burn patients) to minimize potential damage to the sciatic nerve. In adults, the upper outer quadrant of the buttock is considered the preferred injection site. In older children and adolescents, the deltoid region should only be used if well developed and with caution to avoid radial nerve injury. Injections should not be made in the lower or mid-third of the upper arm. Aspirate before injection to avoid inadvertent injection into a blood vessel.

Use: Labeled Indications

Oral:

Anxiety: Symptomatic relief of anxiety.

Pruritus: Management of pruritus due to allergic conditions (eg, atopic and contact dermatoses) and histamine-mediated pruritus.

Urticaria, new onset and chronic spontaneous: Management of urticaria.

IM:

Peripartum management, adjunct to opioids: As prepartum and postpartum adjunctive medication to permit reduction in opioid dosage, allay anxiety, and control emesis.

Urticaria, new onset: Management of urticaria.

Medication Safety Issues

Sound-alike/look-alike issues:

HydrOXYzine may be confused with hydrALAZINE, hydroCHLOROthiazide, HYDROmorphone, hydroxyurea

Atarax may be confused with Ativan

Vistaril may be confused with Restoril, Versed, Zestril

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in early pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

Older Adult: High-Risk Medication:

Beers Criteria: Hydroxyzine, a first-generation antihistamine, is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potent anticholinergic properties resulting in increased risk of confusion, dry mouth, constipation, and other anticholinergic effects or toxicity; use should also be avoided due to reduced clearance with advanced age and tolerance associated with use as a hypnotic. Exposure to concurrent anticholinergic drugs also increases risk of falls, delirium, and dementia; consider total anticholinergic burden when conducting medication reviews (Beers Criteria [AGS 2023]).

Hydroxyzine is 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 in patients with recurrent falls. Use is not recommended for the treatment of insomnia, as first-line treatment of allergy or pruritus, or in patients with delirium or dementia (O’Mahony 2023).

International issues:

Vistaril [US and Turkey] may be confused with Vastarel brand name for trimetazidine [multiple international markets]

Metabolism/Transport Effects

None known.

Drug Interactions

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.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination

Agents with Clinically Relevant Anticholinergic Effects: May enhance the adverse/toxic effect of other Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Amantadine: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy

Amezinium: Antihistamines may enhance the stimulatory effect of Amezinium. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Betahistine may diminish the therapeutic effect of Antihistamines. Risk C: Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect 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

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect 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

Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect 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

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CloZAPine: Agents with Clinically Relevant Anticholinergic Effects may enhance the constipating effect 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

CNS Depressants: HydrOXYzine may enhance the CNS depressant effect 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

Daridorexant: May enhance the CNS depressant effect 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

DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect 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

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

DroPERidol: May enhance the CNS depressant effect 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

Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect 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

Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Agents with Clinically Relevant Anticholinergic Effects may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination

Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Risk C: Monitor therapy

Ipratropium (Nasal): May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination

Itopride: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lemborexant: May enhance the CNS depressant effect 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

Levosulpiride: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Loxapine: CNS Depressants may enhance the CNS depressant effect of Loxapine. Risk D: Consider therapy modification

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect 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

Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirabegron: Agents with Clinically Relevant Anticholinergic Effects may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxatomide: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect 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

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant. Risk X: Avoid combination

Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects may enhance the ulcerogenic effect 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 combination

Potassium Citrate: Agents with Clinically Relevant Anticholinergic Effects may enhance the ulcerogenic effect 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 combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid combination

Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): HydrOXYzine may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Risk C: Monitor therapy

QuiNIDine: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor therapy

Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect 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 enhance the adverse/toxic effect 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

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Secretin: Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect 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

Suvorexant: CNS Depressants may enhance the CNS depressant effect 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

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Agents with Clinically Relevant Anticholinergic Effects may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Agents with Clinically Relevant Anticholinergic Effects may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Tranylcypromine: May enhance the anticholinergic effect of Antihistamines, First Generation. Risk X: Avoid combination

Umeclidinium: May enhance the anticholinergic effect of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid combination

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect 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

Zuranolone: May enhance the CNS depressant effect 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

Pregnancy Considerations

Hydroxyzine crosses the placenta (Prenner 1977; Serreau 2005).

Based on data from animal reproduction studies, the use of hydroxyzine in early pregnancy is contraindicated. Outcome data following maternal use of hydroxyzine in humans during pregnancy are available (Etwel 2017; Hansen 2020; Heinonen 1977; Kocatürk 2022). Possible withdrawal symptoms have been observed in neonates following chronic maternal use of hydroxyzine during pregnancy (Prenner 1977; Serreau 2005).

Hydroxyzine is approved for pre- and postpartum adjunctive therapy to control emesis, reduce opioid dosage, and treat anxiety. However, agents other than hydroxyzine are recommended for the treatment of nausea and vomiting of pregnancy (ACOG 189 2018).

Algorithms are available for the treatment of urticaria. First-generation oral antihistamines are generally not recommended for use in pregnant patients due to side effects (EAACI [Zuberbier 2022]).

Breastfeeding Considerations

It is not known if hydroxyzine is present in breast milk.

Drowsiness and irritability have been reported in breastfed infants exposed to antihistamines (Ito 1993). Sedation has been reported in breastfed infants exposed to hydroxyzine (Soussan 2014). In general, if a breastfed infant is exposed to a first-generation antihistamine via breast milk, they should be monitored for irritability or drowsiness (Butler 2014).

Antihistamines may decrease maternal serum prolactin concentrations when administered prior to the establishment of lactation (Messinis 1985).

Use of a second-generation antihistamine is preferred when an oral antihistamine is needed in lactating patients (EAACI [Zuberbier 2022], Butler 2014).

Monitoring Parameters

Relief of symptoms, mental status and alertness, BP, rash (including worsening of pre-existing skin reactions), signs/symptoms of hypersensitivity reaction.

Mechanism of Action

Competes with histamine for H₁-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract (Simons 1994). Possesses skeletal muscle relaxing, bronchodilator, antihistamine, antiemetic, and analgesic properties. Activity at muscarinic, serotonergic (5HT2), and dopaminergic receptors in the hippocampus, cerebral cortices, and whole brain may produce anxiolytic effects (Guaiana 2010; Sawantdesai 2016).

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Oral: 15 to 30 minutes; IM: Rapid.

Duration: Decreased histamine-induced wheal and flare areas: 2 to ≥36 hours; Suppression of pruritus: 1 to 12 hours (Simons 1984a).

Absorption: Oral: Rapid.

Distribution: Children and Adolescents 1 to 14 years: 18.5 ± 8.6 L/kg (Simons 1984b); Adults: V_d: 16 ± 3 L/kg (Simons 1984a); Elderly: ~23 L/kg (Simons 1989b); Hepatic dysfunction: ~23 L/kg (Simons 1989a).

Metabolism: Hepatic to multiple metabolites, including cetirizine (active) (Simons 1989a).

Half-life elimination:

Children and Adolescents 1 to 14 years (mean age: 6.1 ± 4.6 years): 7.1 ± 2.3 hours; Note: Half-life increased with increasing age and was 4 hours in patients 1 year of age and 11 hours in a 14-year-old patient (Simons 1984b).

Adults: ~20 hours (Simons 1984a); Elderly: ~29 hours (Simons 1989b); Hepatic dysfunction: ~37 hours (Simons 1989a).

Time to peak: Oral administration: Serum: ~2 hours; Peak suppression of antihistamine-induced wheal and flare: 4 to 12 hours (Simons 1984a).

Excretion: Urine; active metabolite (cetirizine) is renally eliminated (Simons 1994).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Atarax;
(AR) Argentina: Ataraxone | Hidroxina | Hyderax | Panaler;
(AT) Austria: Atarax;
(AU) Australia: Atarax;
(BD) Bangladesh: Artica | Atarax | Roxyzin | Xyril;
(BE) Belgium: Atarax;
(BG) Bulgaria: Atarax | Neurolax;
(BR) Brazil: Cloridrato de hidroxizina | Dicloridrato de hidroxizina | Droxy | Hidroxine | Hixizine | Prurizin;
(CH) Switzerland: Atarax;
(CL) Chile: Dalun | Fasarax | Fedox | Nexit;
(CN) China: Hydroxyzine;
(CO) Colombia: Calmofilase | Cedar | Clemaskov | Dormirex | Drowsy | Droxia | Hiderax | Hiderax s | Hidrolan | Hidroxfar | Hidroxicina | Hidroxizina | Histaxina | Indolgin;
(CZ) Czech Republic: Atarax;
(DE) Germany: Ah3 | Atarax | Atarax pb pharma | Elroquil n | Hydroxyzin bluefish;
(DO) Dominican Republic: Atarax | Droxicin | Hidroxicina | Hyderax | Kalm | Pazz | Seda;
(EC) Ecuador: Atarax | Fasarax | Hidroxicina | Hidroxina;
(EE) Estonia: Atarax | Hydroxyzin bluefish | Hydroxyzinum vp;
(EG) Egypt: Atarax;
(ES) Spain: Atarax | Hidroxicina qualigen | Hidroxizina Bluefish;
(FI) Finland: Atarax | Hydroxyzine orifarm | Hydroxyzine sandoz;
(FR) France: Atarax | Hydroxyzine arrow | Hydroxyzine biogaran | Hydroxyzine Bluefish | Hydroxyzine Cristers | Hydroxyzine EG | Hydroxyzine mylan | Hydroxyzine renaudin | Hydroxyzine sandoz | Hydroxyzine Teva | Hydroxyzine zentiva;
(GB) United Kingdom: Atarax | Equipose | Hydroxyzine | Ucerax;
(GR) Greece: Antipsichos | Atarax | Iremofar;
(HK) Hong Kong: Allerax | Apo-hydroxyzine | Atarax | Hydroxyzine | Polizine | Qualidrozine | Rozine | Vatarax;
(HU) Hungary: Atarax;
(ID) Indonesia: Atarax | Bestalin | Iterax;
(IE) Ireland: Atarax | Ucerax;
(IL) Israel: Otarex;
(IN) India: A rex | Amwin's hysure | Anxidol | Atahist | Atarax | Atarax sr | Atazis | Atragence | Atzine | Averzine | Axaria | Braket | D rax | Galadaz | H rax | Hicope | Histozin | Hydil | Hydrax | Hydroze | Hymax | Hynosure | Hyrax | Hyzine | Ktrax | Oltrex | Pru | Prufree | Prugo | Prunil | Prutrax | Prutrax sr | Prutrip | Psytrax | Urtigo | Urtirid | Urtivel | Urtizen | Vistarax | Zoryz | Zylax;
(IS) Iceland: Atarax;
(IT) Italy: Atarax;
(JO) Jordan: Atarax | Newrax;
(JP) Japan: Alamon | Atarax | Atarax-p | Bobsule | Disron | Disron p | Hatanaziin merck hoei | Hatanazin | Primedoron | Vison | Warazix all | Warazix taiyo;
(KE) Kenya: Atarax;
(KR) Korea, Republic of: Adipam | Centilax | Dewbrium | Dudrizine | Hanopam | Hanwha hydroxyzine hydrochloride | Hydroxyzine | Leuzan | Phymorax | Sydraxin | Ucerax | Vistaril;
(KW) Kuwait: Atarax;
(LB) Lebanon: Atarax;
(LT) Lithuania: Atarax | Hydroxizine | Hydroxyzinum | Neurolax;
(LU) Luxembourg: Atarax;
(LV) Latvia: Atarax | Neurolax;
(MA) Morocco: Atarax | Taraxet;
(MX) Mexico: Akiskam | Apodrox | Atarax | Execut | Hidroxizina | Torefega | Xylam;
(MY) Malaysia: Apo-hydroxyzine | Atarax;
(NL) Netherlands: Atarax | Hydroxyzine-2 Hcl;
(NO) Norway: Atarax | Hydroxyzine Bluefish | Hydroxyzine orifarm | Hydroxyzine orion;
(NZ) New Zealand: Atarax | Serecid;
(OM) Oman: Atarax;
(PE) Peru: Atarax;
(PH) Philippines: Droxiem | Iterax | Sedazine;
(PK) Pakistan: Atarax | Roxyzin;
(PL) Poland: Atarax | Droxiem | Hydroxyzine orion | Hydroxyzinum | Hydroxyzinum adamed | Hydroxyzinum alvogen | Hydroxyzinum Espefa | Hydroxyzinum hasco | Hydroxyzinum polfarmex | Hydroxyzinum PPH | Hydroxyzinum vp | Hydroxyzinum zentiva;
(PR) Puerto Rico: Atarax | Hydroxyzine | Hydroxyzine HCL | Hydroxyzine Pam | Hydroxyzine pamoate | Vistaril;
(PT) Portugal: Atarax | Fenartix | Hidroxizina | Hidroxizina Bluefish | Hidroxizina generis;
(PY) Paraguay: Hidroxina | Prurid;
(QA) Qatar: Atarax;
(RO) Romania: Atarax;
(RU) Russian Federation: Atarax | Hydroxyzine | Hydroxyzine canon | Hydroxyzine nativ | Hydroxyzine vertex;
(SA) Saudi Arabia: Apo-hydroxyzine | Atarax;
(SE) Sweden: Atarax | Atyxine | Hydroxizin alternova | Hydroxyzine | Hydroxyzine Bluefish | Hydroxyzine medical valley | Hydroxyzine orifarm | Hydroxyzine orion | Vistaril;
(SG) Singapore: Aa pharma hydroxyzine | Apo-hydroxyzine | Atarax | Hizin | Navicalm | Phymorax;
(SI) Slovenia: Atarax;
(SK) Slovakia: Atarax;
(TH) Thailand: Abacus | Abelax | Abelex | Actadon | Aldrarax | Alerax-fc | Allerax | Alzin | Ammipam Ms | Andrarax | Antipru | Antizine | Antorex | Ata | Atalog | Atamed | Atano | Atarax | Ataril | Ataril F | Atarine | Atryl | Bemax | Buxie | Calmarax | Cerax | Colluzine | Darax | Dicarax | Dormirax | Drazine | Droxim | Drozine | Dyzine | Goose Hyzine | Hadarax | Hadoxine | Histan | Hiszine | Hizin | Honsa | Hycin | Hydan | Hydrarax | Hydrox | Hydroxin | Hydroxyzine | Hyrax | Hyzine | Katrax | Malax | Masarax | Morax | P.D.Rax | Pipzine | Polizine | Postarax | Prurancit | R rax | Raxta | Raxzin | Sinny | Taraxin | Trandrozine | Unamine | Unirax | Vestarax | Xara | Xaxa | Xyzine | Zeniz;
(TN) Tunisia: Atarax | Iremofar;
(TR) Turkey: Atarax | Vistaril;
(TW) Taiwan: Arax | Atarax | Disron | Nirax | Vistaril;
(UA) Ukraine: Atarax | Hydroxyzine zn;
(UY) Uruguay: Ataraxone | Hidroxin | Hidroxina;
(VN) Viet Nam: Philhydarax;
(ZA) South Africa: Aterax | Micro-hydroxyzine | Pharma Q Hydroxyzine

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Hydroxyzine: Drug information