Azelastine is a histamine-1 receptor antagonist sold in the U.S. under 6 brand and generic names, for perennial allergic rhinitis, vasomotor rhinitis and allergic conjunctivitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Azelastine Hydrochloride (application ANDA210092). Other azelastine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dose is one drop instilled into each affected eye twice a day.
In controlled multiple-dose studies where patients were treated for up to 56 days, the most frequently reported adverse reactions were transient eye burning/stinging (approximately 30%), headaches (approximately 15%) and bitter taste (approximately 10%). The occurrence of these events was generally mild. The following events were reported in 1% to 10% of patients: asthma, conjunctivitis, dyspnea, eye pain, fatigue, influenza-like symptoms, pharyngitis, pruritus, rhinitis and temporary blurring. Some of these events were similar to the underlying disease being studied. To report SUSPECTED ADVERSE REACTIONS, contact Fosun Pharma USA Inc. at 1-866-611-3762 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Spray/Inhaler | Generic | $1 | View → | |
| 2 | 70/100 | Prescription | Drops | Generic |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
| $1 |
| View → |
| 3 | 68/100 | Prescription | Spray/Inhaler | Generic | $1 | View → |
| 4 | Not yet rated | Over-the-counter | Spray/Inhaler | Generic | $1 | View → |
| 5 | Not yet rated | Prescription | Drops | Generic | $1 | View → |
| 6 | Not yet rated | Over-the-counter | Spray/Inhaler | Generic | $1 | View → |