Desloratadine

Desloratadine is a long-acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H 1 -receptor.

• Desloratadine Tablets are a histamine-1 (H1) receptor antagonist indicated for: • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) • Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older.ICD-10: J30.9

• Desloratadine Tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [ see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ].contraindicated

Desloratadine Tablets may be taken without regard to meals. Dosage (by age): Adults and Adolescents 12 Years of Age and Over: • Desloratadine Tablets - one 5 mg tablet once daily ( 2 ) 2.1 Adults and Adolescents 12 Years of Age and Over The recommended dose of Desloratadine Tablets is one 5-mg tablet once daily. 2.5 Adults with Hepatic or Renal Impairment In adult patients with liver or renal impairment, a starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. Dosing recommendation for children with liver or renal impairment cannot be made due to lack of data [ see Clinical Pharmacology (12.3) ].

• Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported. In such cases, stop Desloratadine Tablets at once and consider alternative treatments. ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported after administration of desloratadine. If such a reaction occurs, therapy with Desloratadine Tablets should be stopped and alternative treatment should be considered. [ See Adverse Reactions (6.2) .]

The following adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity reactions. [ See Warnings and Precautions (5.1) .] • The most common adverse reactions (reported in ≥2% of adult and adolescent patients with allergic rhinitis and greater than placebo) were pharyngitis, dry mouth, myalgia, fatigue, somnolence, dysmenorrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adults and Adolescents Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received Desloratadine Tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between Desloratadine and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Desloratadine group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving desloratadine.

• Renal impairment: dosage adjustment is recommended ( 2.5 , 8.6 , 12.3 ) • Hepatic impairment: dosage adjustment is recommended ( 2.5 , 8.7 , 12.3 ) 8.1 Pregnancy Risk Summary The limited available data with Desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are no adequate and well-controlled studies in pregnant women. Desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (AUC)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (RHD) of 5 mg/day. Desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the AUC-based exposures of desloratadine approximately 230 times that at the RHD. Desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of F 1 pups at the summed AUC-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the RHD [ see Data ]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S.

Metabolism

Absorption Following oral administration of a desloratadine 5 mg tablet once daily for 10 days to normal healthy volunteers, the mean time to maximum plasma concentrations (T max ) occurred at approximately 3 hours post dose and mean steady state peak plasma concentrations (C max ) and AUC of 4 ng/mL and 56.9 ng∙hr/mL were observed, respectively. Neither food nor grapefruit juice had an effect on the bioavailability (C max and AUC) of desloratadine.

In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Desloratadine and 3-hydroxydesloratadine are not eliminated by hemodialysis. Information regarding acute overdosage is limited to experience from post-marketing adverse event reports and from clinical trials conducted during the development of the Desloratadine product. In a dose-ranging trial, at doses of 10 mg and 20 mg/day somnolence was reported. In another study, no clinically relevant adverse events were reported in normal male and female volunteers who were given single daily doses of Desloratadine 45 mg for 10 days [ see Clinical Pharmacology (12.2) ].

• Dec 21, 2001NDANDA021165Organon
• Feb 1, 2006NDANDA021313Organon Llc
• Feb 19, 2010ANDAANDA078357Orbion Pharms
• Jul 12, 2010ANDAANDA078367Reddys
• Oct 25, 2010ANDAANDA078352Lupin Pharms
• Feb 10, 2012ANDAANDA078351Natco Pharma Usa
• Apr 19, 2012ANDAANDA078355Ajenat Pharms
• May 26, 2016ANDAANDA202936Taro

1. 1Drug Ineffective6125.9%
2. 2Fatigue6115.9%
3. 3Nausea5935.7%
4. 4Dyspnoea5375.1%
5. 5Headache4744.5%
6. 6Diarrhoea4574.4%
7. 7Dizziness4484.3%
8. 8Pruritus4294.1%
9. 9Vomiting4093.9%
10. 10Rash3793.6%
11. 11Off Label Use3253.1%
12. 12Pain3233.1%
13. 13Arthralgia3213.1%
14. 14Asthenia3203.1%
15. 15Pyrexia3153.0%

The 10 most recently updated of 88 ClinicalTrials.gov registrations naming Desloratadine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Desloratadine as Adjunct Therapy for Rheumatoid Arthritis
  Recruiting · Phase 2 · Interventional · 60 enrolled · Horus University
  NCT07632872updated 2026-06-08
• Desloratadine to Prevent Taxane-induced Peripheral Neuropathy in Patients With Breast Cancer
  Recruiting · Phase 2 · Interventional · 116 enrolled · Montefiore Medical Center
  NCT07109817updated 2026-05-29
• Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
  Recruiting · Phase 2 · Interventional · 90 enrolled · Horus University
  NCT07566351updated 2026-05-12
• Autologous Whole Blood Therapy in Chronic Idiopathic Urticaria Patients.
  Not yet recruiting · Phase 3 · Interventional · 40 enrolled · Cairo University
  NCT07486583updated 2026-03-20
• Desloratadine in Patients With Ulcerative Colitis
  Recruiting · Phase 2 · Interventional · 44 enrolled · Tanta University
  NCT07333716updated 2026-01-29
• A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis
  Completed · Phase 3 · Interventional · 236 enrolled · Hoffmann-La Roche
  NCT05232825updated 2025-08-06
• Contribution of Nasal IgE Production to the Boost of Systemic Allergen-specific IgE Upon Nasal Allergen Contact
  Recruiting · Interventional · 30 enrolled · Medical University of Vienna
  NCT05042830updated 2025-05-07
• Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children
  Completed · Phase 3 · Interventional · 262 enrolled · Eurofarma Laboratorios S.A.
  NCT05214911updated 2025-04-17
• Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine
  Recruiting · Phase 3 · Interventional · 70 enrolled · Laboratorios Silanes S.A. de C.V.
  NCT06916884updated 2025-04-08
• The Effect of Omalizumab on Allergic Rhinitis Symptoms: a Comparative Study
  Completed · Phase 4 · Interventional · 50 enrolled · Yuzuncu Yil University
  NCT06806826updated 2025-02-04

Frequently asked questions

How does Desloratadine work?

Desloratadine is a long-acting tricyclic histamine antagonist with selective H 1 -receptor histamine antagonist activity. Receptor binding data indicates that at a concentration of 2-3 ng/mL (7 nanomolar), desloratadine shows significant interaction with the human histamine H 1 -receptor.

What is Desloratadine used for?

According to FDA labeling, Desloratadine carries indications including: Desloratadine Tablets are a histamine-1 (H1) receptor antagonist indicated for: • Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) • Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Desloratadine?

Desloratadine is classified as Other antihistamines for systemic use, Histamine-1 Receptor Antagonist, Histamine H1 Receptor Antagonists, Decreased Histamine Activity.

What are the brand names for Desloratadine?

Desloratadine is marketed under brand names including Clarinex, Clarinex-D.

What are the contraindications for Desloratadine?

Desloratadine labeling lists contraindications including: Desloratadine Tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [ see Warnings and Precautions (5.1) and Adverse Reactions (6.2) ].. Always consult the full prescribing information and a clinician.