Version July 2025
Dosage guidance:
Dosage form information: In the US market, a dosage form may not be readily available to meet dosing needs in younger patients (ie, <6 years of age).
Allergic rhinitis, perennial:
Infants 6 to ≤11 months: Oral: 1 mg once daily.
Children ≤5 years: Oral: 1.25 mg once daily.
Children 6 to ≤11 years: Oral: 2.5 mg once daily.
Children ≥12 years and Adolescents: Oral: 5 mg once daily.
Allergic rhinitis, seasonal:
Children 2 to ≤5 years: Oral: 1.25 mg once daily.
Children 6 to ≤11 years: Oral: 2.5 mg once daily.
Children ≥12 years and Adolescents: Oral: 5 mg once daily.
Urticaria, chronic idiopathic:
Infants 6 to ≤11 months: Oral: 1 mg once daily.
Children ≤5 years: Oral: 1.25 mg once daily.
Children 6 to ≤11 years: Oral: 2.5 mg once daily.
Children ≥12 years and Adolescents: Oral: 5 mg once daily.
There are no dosage adjustments provided in manufacturer's labeling for pediatric patients (has not been studied); based on adult information, dosage adjustment may be necessary.
There are no dosage adjustments provided in manufacturer's labeling for pediatric patients (has not been studied); based on adult information, dosage adjustment may be necessary.
(For additional information see "Desloratadine: Drug information")
Allergic rhinitis, perennial or seasonal: Oral: 5 mg once daily.
Angioedema, acute allergic or recurrent idiopathic (off-label use):
Note: Not indicated for angioedema associated with anaphylaxis; use epinephrine if anaphylaxis symptoms are present (ie, risk of airway or cardiovascular compromise) (Ref).
Oral: 5 mg once or twice daily; may increase up to 10 mg twice daily (Ref).
Urticaria, new onset (off-label use) and chronic spontaneous (labeled use):
New onset: Oral: Initial: 5 mg once daily. If symptom control is inadequate, may immediately increase to 5 mg twice daily (Ref).
Chronic spontaneous: Oral: Initial: 5 mg once daily. If symptom control is inadequate, may increase in 5 mg/day increments every 1 to 4 weeks up to 10 mg twice daily; periodically reevaluate necessity for continued treatment (Ref).
Urticaria, NSAID associated, prophylaxis (off-label use): Oral: 5 mg 30 minutes before intake of a strong COX-1 inhibitor (Ref).
Moderate to severe impairment: No dosage adjustment necessary; use with caution in severe impairment. Although the US manufacturer’s labeling recommends a dose reduction to 5 mg every other day in patients with mild to severe renal impairment, the increased exposure (Cmax and AUC) observed in single- and multiple-dose pharmacokinetic studies is not considered clinically relevant (Ref).
Hemodialysis: Poorly dialyzable: No dosage adjustment necessary; use with caution. Although the US manufacturer’s labeling recommends a dose reduction to 5 mg every other day in patients on dialysis, the increased exposure (Cmax and AUC) observed in single- and multiple-dose pharmacokinetic studies is not considered clinically relevant (Ref).
No dosage adjustment necessary; use with caution in severe impairment. Although the US manufacturer’s labeling recommends a dose reduction to 5 mg every other day in patients with mild to severe hepatic impairment, the increased exposure (Cmax and AUC) observed in single- and multiple-dose pharmacokinetic studies is not considered clinically relevant (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in children, adolescents, and adults unless otherwise indicated.
>10%:
Gastrointestinal: Diarrhea (infants and children: 15% to 20%)
Nervous system: Headache (14%), irritability (infants: 12%)
Respiratory: Cough (infants and children: 11%), upper respiratory tract infection (infants and children: 11% to 21%)
Miscellaneous: Fever (infants and children: 5% to 17%)
1% to 10%:
Dermatologic: Erythema of skin (infants: 3%), maculopapular rash (children: 3%)
Gastrointestinal: Anorexia (infants: 5%), dyspepsia (3%), increased appetite (children: 3%), nausea (infants, children, adolescents, and adults: 3% to 5%), vomiting (infants: 6%), xerostomia (3%)
Genitourinary: Urinary tract infection (children: 4%)
Infection: Parasitic infection (children: 3%), varicella zoster infection (children: 4%)
Nervous system: Dizziness (4%), drowsiness (infants: 9%), emotional lability (children: 3%), fatigue (2% to 5%), insomnia (infants: 5%)
Neuromuscular & skeletal: Myalgia (3%)
Respiratory: Bronchitis (infants: 6%), epistaxis (children: 3%), pharyngitis (infants, children, adolescents, and adults: 3% to 5%)
Postmarketing (any population):
Cardiovascular: Palpitations, tachycardia
Dermatologic: Pruritus, skin rash
Hepatic: Hepatitis, increased liver enzymes (including increased serum bilirubin)
Hypersensitivity: Hypersensitivity reaction (including anaphylaxis)
Nervous system: Movement disorder (including dystonia, extrapyramidal reaction, tic disorder), psychomotor agitation, seizure
Respiratory: Dyspnea
Hypersensitivity to desloratadine, loratadine, or any component of the formulation
Concerns related to adverse effects:
• Hypersensitivity: Hypersensitivity reactions (including anaphylaxis) have been reported with use; discontinue therapy immediately with signs/symptoms of hypersensitivity.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with severe hepatic impairment.
• Renal impairment: Use with caution in patients with severe renal impairment.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Slow metabolizers: Use with caution in patients known to be slow metabolizers of desloratadine (incidence of side effects may be increased).
Dosage form specific issues:
• Phenylalanine: Some products may contain phenylalanine.
Desloratadine may increase susceptibility to seizures in pediatric patients, particularly in patients with a history of seizure disorders; 1 case series described 4 patients (ages: 5 to 16 years) who experienced seizures after initiation of desloratadine. Three of the 4 patients had known seizure disorders that were controlled prior to treatment with desloratadine. The final patient, who developed absence seizures after initiation of desloratadine, had a family history of febrile seizures but no personal history of seizure disorder (Cerminara 2013).
Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age are limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported. Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
Clarinex: 5 mg [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake]
Clarinex: 5 mg [DSC] [contains fd&c blue #2 (indigo carm) aluminum lake]
Generic: 5 mg
Tablet Disintegrating, Oral:
Generic: 2.5 mg, 5 mg
Yes
Tablet, orally-disintegrating (Desloratadine Oral)
2.5 mg (per each): $5.83
5 mg (per each): $5.83
Tablets (Clarinex Oral)
5 mg (per each): $10.58
Tablets (Desloratadine Oral)
5 mg (per each): $5.02 - $8.69
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:
Generic: 5 mg
Oral: May administer without regard to food.
Orally dissolving tablet: Place orally dissolving tablet directly on the tongue; tablet will disintegrate immediately; may be taken with or without water. Take immediately after removing from blister package.
May be taken with or without food.
Orally disintegrating tablets should be placed on the tongue; tablet will disintegrate immediately. Take immediately after removing from blister package. Allow tablet to dissolve completely before swallowing. May be taken with or without water.
Tablet, orally disintegrating: Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 85°F). Protect from moisture and excessive heat. Use orally disintegrating tablet immediately after opening blister package.
Symptomatic relief of nasal and non-nasal symptoms of perennial allergic rhinitis (FDA approved in ages ≥6 months and adults); symptomatic relief of nasal and non-nasal symptoms of seasonal allergic rhinitis (FDA approved in ages ≥2 years and adults); symptomatic relief and reduction in number and size of hives in chronic idiopathic urticaria (FDA approved in ages ≥6 months and adults).
Clarinex may be confused with Celebrex
Substrate of CYP2C8 (Major with inhibitors), CYP2C8 (Minor with inducers), P-glycoprotein (Minor); 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
Amezinium: Antihistamines may increase stimulatory effects of Amezinium. Risk C: Monitor
Benzylpenicilloyl Polylysine: Coadministration of Antihistamines and Benzylpenicilloyl Polylysine may alter diagnostic results. 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 decrease therapeutic effects of Betahistine. Betahistine may decrease therapeutic effects of Antihistamines. Risk C: Monitor
Certoparin: Antihistamines may increase therapeutic effects of Certoparin. Risk C: Monitor
CYP2C8 Inhibitors (Moderate): May increase serum concentration of Desloratadine. Risk C: Monitor
CYP2C8 Inhibitors (Strong): May increase serum concentration of Desloratadine. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Hyaluronidase: Antihistamines may decrease therapeutic effects of Hyaluronidase. Risk C: Monitor
Lumacaftor and Ivacaftor: May decrease serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase serum concentration of CYP2C8 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor
Pitolisant: Antihistamines may decrease therapeutic effects of Pitolisant. Risk X: Avoid
QT-prolonging Agents (Highest Risk): 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
Food does not affect bioavailability.
Some products may contain phenylalanine.
Outcome data following maternal use of desloratadine during pregnancy are available (Andersson 2020, Layton 2009). Based on the limitations of available data, second-generation antihistamines are considered acceptable for use during pregnancy, with preference given to agents with more study (EAACI [Zuberbier 2022]).
Algorithms are available for the treatment of acute rhinitis and urticaria. When treatment with a second-generation oral antihistamine is recommended, agents other than desloratadine may be preferred for use during pregnancy (AAAAI/ACAAI [Dykewicz 2020], EAACI [Zuberbier 2022]).
CNS symptoms including sedation.
Desloratadine, a major active metabolite of loratadine, is a long-acting tricyclic antihistamine with selective peripheral histamine H1-receptor antagonistic activity.
Onset of action: Within 1 hour.
Duration: 24 hours.
Distribution: Vd: ~49 L/kg (Devillier 2008).
Protein binding: Desloratadine: 82% to 87%; 3-hydroxydesloratadine (active metabolite): 85% to 89%.
Metabolism: Hepatic to active metabolite, 3-hydroxydesloratadine (specific enzymes not identified); subsequently undergoes glucuronidation. Decreased in slow metabolizers of desloratadine.
Half-life elimination:
Children 2 to 5 years: Mean: 16.4 hours (Gupta 2007).
Children 6 to 11 years: Mean: 19.4 hours (Gupta 2007).
Adults: ~27 hours.
Time to peak:
Children 2 to 5 years: Mean: 3.17 hours (range: 1.5 to 8 hours) (Gupta 2007).
Children 6 to 11 years: Mean: 3.57 hours (range: 4 to 12 hours) (Gupta 2007).
Adults: ~3 hours.
Excretion: Urine (41% of radioactive dose); feces (47% of radioactive dose) (Devillier 2008).
Altered kidney function: AUC and Cmax are increased.
Hepatic function impairment: AUC and half-life are increased.
Pediatric: Systemic exposure in children (based on AUC and Cmax) is similar to adults (Gupta 2007).
Older adult: Cmax and AUC are 20% higher. The half-life is 33.7 hours.
