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Molecule

Desloratadine

Histamine-1 Receptor Antagonist
Available on request
Presentations
5
Brands
1
Manufacturers
1
Available from stock
0

Desloratadine is a histamine-1 receptor antagonist indicated for seasonal Allergic Rhinitis, among other approved uses. It is available as tablets, orally disintegrating tablets and oral solution. MedsAcross supplies Desloratadine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Histamine-1 Receptor Antagonist, Histamine H1 Receptor Antagonists
ATC classification
R06AX27 Desloratadine · Histamine antagonist, subgroup R06AX
US FDA first approval
21 December 2001
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet, Orally disintegrating tablet, Oral solution
Identifiers
UNII FVF865388RRxCUI 275635CAS 100643-71-8DrugBank DB00967Q418060

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

CLARINEX is a histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 2 years of age and older. Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 6 months of age and older. Chronic Idiopathic Urticaria: symptomatic relief of pruritus, reduction in the number of hives, and size of hives in patients 6 months of age and older.

Source: US FDA prescribing information

How it works

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 inhibited histamine release from human mast cells in vitro. Results of a radiolabeled tissue distribution study in rats and a radioligand H 1 -receptor binding study in guinea pigs showed that desloratadine did not readily cross the blood brain barrier. The clinical significance of this finding is unknown.

Source: US FDA prescribing information

Dosing overview

Although the oral solution and the orally disintegrating tablet formulation of desloratadine may be available in the marketplace, CLARINEX ® Oral Solution and CLARINEX ® RediTabs ® Tablets are no longer marketed. CLARINEX Tablets, Oral Solution, or RediTabs Tablets may be taken without regard to meals. Place CLARINEX (desloratadine) RediTabs Tablets on the tongue and allow to disintegrate before swallowing. Tablet disintegration occurs rapidly. Administer with or without water. Take tablet immediately after opening the blister. The age-appropriate dose of CLARINEX Oral Solution should be administered with a commercially available measuring dropper or syringe that is calibrated to deliver 2 mL and 2.5 mL (½ teaspoon).

Source: US FDA prescribing information

Contraindications

CLARINEX Tablets, RediTabs, and Oral Solution are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine. Hypersensitivity

Source: US FDA prescribing information

Warnings and precautions

Hypersensitivity reactions including rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis have been reported. In such cases, stop CLARINEX at once and consider alternative treatments.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity reactions. 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.

Source: US FDA prescribing information

Interactions

Inhibitors of Cytochrome P450 3A4 In controlled clinical studies co-administration of desloratadine with ketoconazole, erythromycin, or azithromycin resulted in increased plasma concentrations of desloratadine and 3 hydroxydesloratadine, but there were no clinically relevant changes in the safety profile of desloratadine.

Source: US FDA prescribing information

Storage

Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Avoid exposure at or above 30°C (86°F).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

5 presentations of Desloratadine, sorted by availability.

MedicineManufacturerRegisterAvailability
Desloratadine 5 mg tabletOralGeneric name—US FDAAvailable on request
Clarinex 5 mg tabletOralOrganonUS FDAAvailable on request
Desloratadine 2.5 mg orally disintegrating tabletOralGeneric name—US FDAAvailable on request
Desloratadine 5 mg orally disintegrating tabletOralGeneric name—US FDAAvailable on request
Desloratadine 0.5 mg/mL oral solutionOralGeneric name—US FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 21 December 2001Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Desloratadine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Desloratadine available for export from India?

Yes, on request. MedsAcross lists 5 presentations of Desloratadine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Desloratadine have?

The catalogue lists 1 brand names for Desloratadine, including Clarinex.

Is Desloratadine approved by the US FDA?

Yes. The US FDA first approved Desloratadine on 21 December 2001, according to Drugs@FDA.

Is Desloratadine authorised in the European Union?

Yes. Desloratadine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Desloratadine need cold chain shipping?

No listed presentation of Desloratadine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Desloratadine in?

Desloratadine is classified under ATC code R06AX27 (Desloratadine).

References

  1. Clarinex prescribing information (Organon). U.S. National Library of Medicine, DailyMed. Retrieved 17 May 2025
  2. Aerius: European public assessment report (EPAR). European Medicines Agency. Retrieved 19 March 2026
  3. Azomyr: European public assessment report (EPAR). European Medicines Agency. Retrieved 2 March 2026

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