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Molecule

Azelastine

Also known as azelastine hydrochloride
Available on requestOphthalmology
Presentations
4
Brands
0
Manufacturers
0
Available from stock
0

Azelastine is a histamine-1 receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults, among other approved uses. MedsAcross supplies Azelastine 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
R01AC03 Azelastine · Topical decongestant, subgroup R01ACR06AX19 Azelastine · Histamine antagonist, subgroup R06AXS01GX07 Azelastine · Eye medicines, subgroup S01G, subgroup S01GX
US FDA first approval
1 November 1996
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Nasal, Intraocular, Ophthalmic
Dosage forms
Nasal spray, Injection, Eye drops
Identifiers
UNII ZQI909440XRxCUI 18603CAS 58581-89-8DrugBank DB00972Q419820

Clinical information

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

Uses

Azelastine hydrochloride nasal spray is indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older, and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older. Azelastine hydrochloride nasal spray is an H1-receptor antagonist indicated for the treatment of the symptoms of seasonal allergic rhinitis in adults and pediatric patients 5 years and older and for the treatment of the symptoms of vasomotor rhinitis in adults and adolescent patients 12 years and older.

Source: US FDA prescribing information

How it works

Azelastine hydrochloride, a phthalazinone derivative, exhibits histamine H1-receptor antagonist activity in isolated tissues, animal models, and humans. Azelastine hydrochloride nasal spray is administered as a racemic mixture with no difference in pharmacologic activity noted between the enantiomers in in vitro studies. The major metabolite, desmethylazelastine, also possesses H1-receptor antagonist activity.

Source: US FDA prescribing information

Dosing overview

For intranasal use only. Seasonal allergic rhinitis: Pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily. Adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily. Vasomotor rhinitis: 2 sprays per nostril twice daily in adults and adolescents 12 years of age and older. Prime azelastine hydrochloride nasal spray before initial use and when it has not been used for 3 or more days

Source: US FDA prescribing information

Warnings and precautions

Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking azelastine hydrochloride nasal spray. Alcohol and other central nervous system (CNS) depressants: Avoid concurrent use with azelastine hydrochloride nasal spray because further decreased alertness and impairment of CNS performance may occur.

Source: US FDA prescribing information

Side effects

Use of azelastine hydrochloride nasal spray has been associated with somnolence. The most common adverse reactions (≥2% incidence) are: bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase.

Source: US FDA prescribing information

Interactions

Central Nervous System Depressants Concurrent use of azelastine hydrochloride nasal spray with alcohol or other central nervous system depressants should be avoided because reductions in alertness and impairment of central nervous system performance may occur.

Source: US FDA prescribing information

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

All presentations

4 presentations of Azelastine, sorted by availability.

MedicineManufacturerRegisterAvailability
Azelastine 137 mcg nasal sprayNasalGeneric name—US FDAAvailable on request
Azelastine 3 mg/6 mL injectionIntraocularGeneric name—US FDAAvailable on request
Azelastine 0.5 mg/mL eye dropsOphthalmicGeneric name—US FDAAvailable on request
Azelastine 1 mg/mL nasal sprayNasalGeneric name—US FDAAvailable on request

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 1 November 1996Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

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

Giant papillary conjunctivitis Seasonal allergic rhinitis Sinusitis Vasomotor rhinitis Vernal conjunctivitis

Questions and answers

Is Azelastine available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Azelastine and sources them for licensed hospitals, importers and physicians against valid import documents.

Is Azelastine approved by the US FDA?

Yes. The US FDA first approved Azelastine on 1 November 1996, according to Drugs@FDA.

Does Azelastine need cold chain shipping?

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

Which ATC class is Azelastine in?

Azelastine is classified under ATC code R01AC03 (Azelastine).

References

  1. Azelastine Hydrochloride prescribing information (Apotex). U.S. National Library of Medicine, DailyMed. Retrieved 8 September 2026

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