Azelastine Ophthalmic
Azelastine ophthalmic is an antihistamine eye drop used to relieve eye itching caused by allergic conjunctivitis.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Azelastine Ophthalmic: Patient Information Guide
A plain-language walkthrough of Azelastine Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Azelastine ophthalmic is an antihistamine eye drop approved for the following use:
- Azelastine Hydrochloride Ophthalmic Solution 0.05% treats itching of the eye caused by allergic conjunctivitis (an allergic reaction affecting the eyes)
⚙️How it works▾
Azelastine is an antihistamine that works by blocking histamine H1 receptors in the eye. When you're exposed to an allergen, your body releases histamine — a chemical that binds to these receptors and triggers itching and irritation. By blocking those receptors, azelastine stops histamine from causing that reaction. Its main active breakdown product in the body, desmethylazelastine, also blocks H1 receptors, adding to the overall effect.
💊How it's taken▾
Azelastine Hydrochloride Ophthalmic Solution 0.05% is applied directly to the eye. The recommended dose is one drop instilled into each affected eye twice a day. Always follow your prescriber's specific instructions — if you miss a dose, apply it as soon as you remember, but skip it if it's nearly time for your next dose. Never double up.
🤒Side effects — in detail▾
Most side effects with azelastine eye drops are mild and happen right after you put in the drops. Common ones include:
- Burning or stinging in the eye (affects about 1 in 3 people)
- Headache (affects about 1 in 7 people)
- Bitter taste (affects about 1 in 10 people)
- Temporary blurred vision
- Eye pain
- Fatigue
- Runny nose or nasal symptoms
- Difficulty breathing or asthma symptoms
Call your doctor if you develop worsening eye pain, trouble breathing, or any signs of a reaction to the drops themselves.
⚠️Warnings & precautions▾
- For the eye only: Azelastine Hydrochloride Ophthalmic Solution 0.05% must never be injected or swallowed — it is strictly an eye drop.
- Allergy to ingredients: Do not use this product if you have a known or suspected allergy to azelastine or any other ingredient in the solution.
🔀What it interacts with▾
The FDA label for azelastine ophthalmic solution does not list specific drug, food, or supplement interactions for this eye drop formulation.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use if you are allergic to azelastine or any component of the solution
- Tell your doctor or pharmacist about all other eye drops or medications you are currently using
- This solution is for ocular (eye) use only — never take by mouth or inject
📡Pharmacodynamics — effects in the body▾
Azelastine blocks histamine H1 receptors, which are responsible for allergic itch and irritation. Studies with oral and nasal forms of azelastine have shown it does not meaningfully affect the heart's electrical rhythm (QTc interval) at recommended doses, suggesting a favorable cardiac safety profile at therapeutic levels.
🔬Pharmacokinetics — how your body processes it▾
Pharmacokinetic data in the label is primarily from intranasal and oral forms of azelastine. After intranasal use, about 40% of the dose reaches the bloodstream, with peak levels in 2 to 3 hours. The drug is broken down in the liver via the cytochrome P450 enzyme system into its active metabolite, desmethylazelastine. Azelastine has an elimination half-life of about 22 hours, meaning it takes roughly a day for half the drug to leave the body, and about 75% of an oral dose is eliminated through the feces.
📦How to store it▾
Azelastine hydrochloride ophthalmic solution, USP 0. Store UPRIGHT between 2° and 25°C (36° and 77°F).
📄 Written from Azelastine Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Azelastine Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What is this eye drop actually for? ▾
How do I use the drops correctly? ▾
My eyes burned after I put in the drops — is that normal? ▾
Are there any side effects I should actually worry about? ▾
Can I use these drops if I'm allergic to one of the ingredients? ▾
Can I use these drops with other eye medications? ▾
Is Azelastine Ophthalmic available over the counter? ▾
When was Azelastine Ophthalmic first available? ▾
Who makes Azelastine Ophthalmic? ▾
💬 Answers drafted from Azelastine Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Azelastine Ophthalmic comes
Azelastine Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Azelastine Hydrochloride Ophthalmic Solution 0.05% is used to treat itching of the eye associated with allergic conjunctivitis
- Azelastine Hydrochloride Ophthalmic Solution 0.05%: instill one drop into each affected eye twice a day
- Azelastine Hydrochloride Ophthalmic Solution 0.05% is for use in the eye only — do not inject or swallow
- Follow your prescriber's directions and the label on your bottle for exact guidance
📊 Azelastine Ophthalmic across the U.S. market
How Azelastine Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Azelastine Ophthalmic is used
A general measure of how commonly Azelastine Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Azelastine Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Azelastine Ophthalmic prescribed? Of the 1,596 medications we measure, Azelastine Ophthalmic ranks #304 by Medicaid prescriptions — more than 81% of them.
Utilization by Azelastine Ophthalmic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
azelastine hydrochloride 0.5 MG/ML Ophthalmic Solution
Summed across the 6 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860805
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azelastine Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 9 listed Azelastine Ophthalmic NDCs with Medicaid activity.
🔍 Compare Azelastine Ophthalmic products
A representative set of FDA-listed product records for Azelastine Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 0.5 mg/mL | Ophthalmic | Alembic Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Somerset Therapeutics, LLC × 3 listings | ANDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Azelastine Ophthalmic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Azelastine Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Azelastine Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Azelastine Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 18603 2 dose forms · 3 strengths
-
Dose form (SCDF) Metered Dose Nasal Spray RxCUI 1797866No current FDA listingClinical drug / strength (SCD) hydrochloride 0.137 MG/ACTUATRxCUI 1797867hydrochloride 0.206 MG/ACTUATRxCUI 1797883 -
Dose form (SCDF) Ophthalmic Solution RxCUI 636216In current FDA listingsClinical drug / strength (SCD) hydrochloride 0.5 MG/MLRxCUI 860805
Look up RxCUI 18603 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Azelastine Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Azelastine Ophthalmic belongs to the Histamine-1 Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 3 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Alembic Pharmaceuticals Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.