What Is Azelastine Used For? FDA-Approved Uses

The FDA label says: “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.”

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Azelastine Hydrochloride, spray, metered

Indications and Usage, quoted from the label by Apotex Corp. (ANDA077954). Cross-references to other label sections are left out.

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.

Source: DailyMed label, set id 4f58c203-f649-a18e-aaf3-70b0797652f4, version 14, effective September 8, 2026. NDC 60505-0833, one of 12 listings for this product.

Azelastine Hydrochloride, solution/ drops

Indications and Usage, quoted from the label by Apotex Corp. (ANDA078621). Cross-references to other label sections are left out.

Azelastine hydrochloride ophthalmic solution is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.

Source: DailyMed label, set id 77a33738-ffcf-221c-1562-780418882e5d, version 11, effective September 8, 2026. NDC 60505-0578, one of 8 listings for this product.

Questions

What is azelastine used for?

The FDA label says: “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.”

What drug class is azelastine?

FDA lists azelastine in the Histamine-1 Receptor Antagonist established pharmacologic class.

Does this page cover off-label uses or dosing?

No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.