Epinastine Ophthalmic
Epinastine ophthalmic is an antihistamine eye drop used to prevent 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 1 clinical label set 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 →
📖 Epinastine Ophthalmic: Patient Information Guide
A plain-language walkthrough of Epinastine 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▾
Epinastine ophthalmic solution is an antihistamine eye drop approved for the following use:
- Prevention of eye itching caused by allergic conjunctivitis — the seasonal or year-round eye irritation triggered by allergens such as pollen, dust, or pet dander
⚙️How it works▾
Epinastine is a topical antihistamine that targets the root cause of allergic eye itching in two ways. First, it directly blocks histamine H1 receptors in the eye — these are the switches that allergens flip to cause itching. Second, it helps stop mast cells (small immune cells packed with histamine) from releasing that histamine in the first place. It also has some affinity for H2, alpha-1, alpha-2, and 5-HT2 receptors, though its primary benefit in the eye comes from H1 blockade. The result: the allergic itch-and-irritation cycle is interrupted before it starts.
💊How it's taken▾
Epinastine HCl ophthalmic solution is applied directly to the eyes — one drop in each eye, twice a day. It does not involve food timing, since it goes into the eye rather than the stomach.
- Use it every day throughout your allergy season or for as long as you're exposed to the allergen, even when your eyes feel comfortable
- If you wear soft contact lenses, remove them before applying the drops and wait at least 10 minutes before putting them back in
- Always follow your prescriber's instructions for your specific situation
🤒Side effects — in detail▾
Most side effects with epinastine HCl eye drops are mild and occur in the eye itself. Common reactions include:
- Burning sensation in the eye
- Eye itching (pruritus)
- Eye redness (hyperemia)
- Folliculosis (small bumps on the inner surface of the eyelid)
- Cold symptoms or upper respiratory infections
- Headache
- Runny nose (rhinitis), sinus congestion, increased cough, or sore throat
- Increased tearing (reported in real-world use after the drug was approved)
If you notice signs of an eye infection — significant pain, worsening redness, or discharge — or if you have any sudden changes in vision, contact your doctor right away.
⚠️Warnings & precautions▾
- Keep the dropper tip sterile. Never let the tip touch your eye, eyelid, fingers, or any other surface. Contaminated drops can cause serious eye infections that may permanently affect vision. Keep the bottle capped when not in use.
- Contact lens caution: The preservative benzalkonium chloride can be absorbed by soft contact lenses. Always remove lenses before using the drops and wait at least 10 minutes before reinserting them. Do not use this product to treat contact lens-related irritation, and do not use it when your eye is red from lenses.
- For eyes only: Epinastine HCl ophthalmic solution is for topical eye use only — it is not for injection or oral use.
🔀What it interacts with▾
The FDA label for epinastine HCl ophthalmic solution does not identify specific drug, food, or supplement interactions to flag.
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▾
- Pregnancy: There are no adequate studies in pregnant women. Animal studies at very high doses (far above the eye-drop amount) showed some effects. Use only if your doctor decides the benefit outweighs the potential risk.
- Breastfeeding: It is unknown whether epinastine passes into human breast milk. Talk to your doctor before using it while nursing.
- Children under 2: Safety and effectiveness have not been established in this age group.
- Older adults: No meaningful differences in safety or effectiveness have been seen compared to younger adults.
- Contact lens wearers: Remove soft lenses before use and wait 10 minutes before reinserting. Do not use for lens-related eye redness.
🔬Pharmacokinetics — how your body processes it▾
Because epinastine is given as an eye drop, very little enters the bloodstream. In a study of people with allergic conjunctivitis using one drop in each eye twice daily for seven days, peak blood levels were extremely low — only about 0.04 ng/mL, reached roughly two hours after a dose. Systemic (whole-body) absorption does not increase with continued use over time.
Once in the body, about 64% of epinastine binds to plasma proteins. Its half-life — the time it takes the body to clear half the drug — is approximately 12 hours. Less than 10% is broken down (metabolized); most is cleared unchanged, primarily through the kidneys via active tubular secretion, with about 30% leaving through the feces.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
📄 Written from Epinastine 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 Epinastine Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does this eye drop do? ▾
Do I need to use it every day, or just when my eyes are itchy? ▾
I wear contact lenses. Is there anything I need to know? ▾
What side effects should I expect, and when should I be concerned? ▾
Is it safe to use during pregnancy or while breastfeeding? ▾
How do I use the drops without contaminating them? ▾
Is Epinastine Ophthalmic available over the counter? ▾
When was Epinastine Ophthalmic first available? ▾
Who makes Epinastine Ophthalmic? ▾
💬 Answers drafted from Epinastine 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 Epinastine Ophthalmic comes
Epinastine 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
- EPINASTINE HYDROCHLORIDE ophthalmic solution is used to prevent itching associated with allergic conjunctivitis
- EPINASTINE HYDROCHLORIDE: instill one drop in each eye twice a day
- EPINASTINE HYDROCHLORIDE: continue use throughout your allergy season or exposure period, even when symptoms are absent
- EPINASTINE HYDROCHLORIDE: remove contact lenses before instilling the drops; wait at least 10 minutes before reinserting
- EPINASTINE HYDROCHLORIDE: do not let the dropper tip touch your eye, skin, or any surface — keep bottle tightly closed when not in use
📊 Epinastine Ophthalmic across the U.S. market
How Epinastine 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 Epinastine Ophthalmic is used
A general measure of how commonly Epinastine 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 Epinastine 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 Epinastine Ophthalmic prescribed? Of the 1,596 medications we measure, Epinastine Ophthalmic ranks #1,077 by Medicaid prescriptions — more than 33% of them.
Utilization by Epinastine 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.
epinastine hydrochloride 0.5 MG/ML Ophthalmic Solution
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 860654
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 Epinastine 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 1 of 6 listed Epinastine Ophthalmic NDCs with Medicaid activity.
🔍 Compare Epinastine Ophthalmic products
A representative set of FDA-listed product records for Epinastine 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 | Breckenridge Pharmaceutical, Inc. × 2 listings | ANDA | View NDC → |
| 0.5 mg/mL | Ophthalmic | Somerset Therapeutics, LLC × 3 listings | ANDA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Epinastine 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 Epinastine 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 Epinastine 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 Epinastine 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 39684 1 dose form · 1 strength
-
Dose form (SCDF) Ophthalmic Solution RxCUI 402322In current FDA listingsClinical drug / strength (SCD) hydrochloride 0.5 MG/MLRxCUI 860654
Look up RxCUI 39684 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 Epinastine 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
Epinastine Ophthalmic belongs to the Histamine-1 Receptor Inhibitor 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 1 FDA-filed SPL label set 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. Somerset Therapeutics, LLC 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.