Azelastine: uses, dosing, side effects & brands
Azelastine is a histamine-1 receptor antagonist sold in the U.S. under 6 brand and generic names, for allergic conjunctivitis, perennial allergic rhinitis and vasomotor rhinitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Histamine-1 Receptor Antagonist
- Treats (across its forms)
- Allergic Conjunctivitis, Perennial Allergic Rhinitis and Vasomotor Rhinitis
- Available as
- Spray/Inhaler, metered · Drops
- Sold as
- 6 products — Astelin, Optivar and Astepro, and others
- Prescription?
- Both Rx and OTC forms
- Generic available?
- Yes
- What the pharmacy pays
- about $0.58 per ml — not your price
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How azelastine is dosed
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.
Azelastine side effects
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.
Who shouldn’t take azelastine
Azelastine hydrochloride ophthalmic solution is contraindicated in persons with known or suspected hypersensitivity to any of its components.
Every azelastine product we track (6)
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? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Spray/Inhaler | Generic | $1 | View → | |
| 2 | 72/100 | Prescription | Drops | Generic | $1 | View → | |
| 3 | 70/100 | 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 → |
Combination products containing azelastine
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.
Azelastine recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long azelastine keeps
No azelastine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does azelastine expire? The in-use limits and storage rules from its labelsAzelastine and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for azelastine: levels in milk, effects in breastfed infants, and the drugs it would consider insteadSmall occasional doses of azelastine nasal spray would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use of the nasal spray may cause drowsiness and other effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Infant rejection of the breast might occur because of the bitter taste of the drug. The oral, nonsedating antihistamines are preferred alternatives.
National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about azelastine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7,463 reports naming azelastine, and the FDA flagged 31% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- treatment failure782 reports
- fatigue540 reports
- dyspnoea473 reports
- headache472 reports
- cough443 reports
- product delivery mechanism issue392 reports
- nausea382 reports
- sinusitis361 reports
Read these as a signal, not a rate. A report does not mean azelastine caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is azelastine?
Azelastine hydrochloride ophthalmic solution, 0.05% is a sterile ophthalmic solution containing azelastine hydrochloride, a relatively selective H 1 -receptor antagonist for topical administration to the eyes.
What kind of drug is azelastine?
The FDA classifies azelastine as a histamine-1 receptor antagonist. H1 antihistamines work by blocking histamine, the chemical released during an allergic reaction, from attaching to H1 receptors. This prevents the sneezing, itching, runny nose, watery eyes, and hives that histamine would otherwise trigger. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take azelastine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run azelastine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is azelastine sold under?
We track 6 azelastine-containing products in the U.S.: Astelin, Optivar, Astepro, Astepro Allergy, Azelastine Hydrochloride and Children's Astepro Allergy. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does azelastine come in?
Across the brands we track, azelastine is currently marketed as spray/inhaler, metered and drops, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic azelastine?
Yes. Our catalog lists 1 generic azelastine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has azelastine been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions azelastine. The most recent: Azelastine HCl Ophthalmic Solution (May 28, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Azelastine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/azelastine
- MLA
- “Azelastine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/azelastine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for azelastine on DailyMed (NIH) ↗.