Over-the-counter medication · Antihistamine / Mast Cell Stabilizer (Ophthalmic)

ketotifen ophthalmic

Also sold as Zaditor, Alaway. These eye drops treat itchy eyes caused by allergies.

Data updated 2026-05-15

$0.86
Brand price (NADAC)

ketotifen ophthalmic (Zaditor) is an over-the-counter Antihistamine / Mast Cell Stabilizer (Ophthalmic). These eye drops treat itchy eyes caused by allergies.

Ketotifen eye drops help relieve itchy eyes. They work by blocking histamine and stabilizing mast cells in your eyes.

Drug Pricing (NADAC)

Brand Price

$0.86/unit

Generic Price

$1.24/unit

Generic Available

Yes (3 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

These eye drops treat itchy eyes caused by allergies.

Common side effects

No common side effects listed.

Key warnings

No specific warnings noted. Always follow your prescriber's instructions.

The sections below are summarized in plain English from ketotifen ophthalmic's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Ketotifen is an antihistamine and mast cell stabilizer. It blocks histamine, a substance that causes allergic symptoms. It also prevents mast cells from releasing substances that cause itching.

Common Questions

What is ketotifen?
Ketotifen is an antihistamine eye drop that relieves itchy eyes.
How often can I use these eye drops?
Use 1 drop in each affected eye twice daily, every 8-12 hours.
Can children use these eye drops?
Yes, children 3 years and older can use them. Ask a doctor for children under 3.
What if I wear contact lenses?
The drug label does not contain information about contact lenses. Ask your doctor.
Can I use these eye drops for other eye problems?
No, these eye drops are only for itchy eyes due to allergies.
What should I do if the itching gets worse?
Talk to your doctor if your symptoms worsen or do not improve.
How long does it take for the drops to work?
The drug label does not contain information about how long the drops take to work. Ask your doctor.
Can I use these with other eye drops?
The drug label does not contain information about using with other eye drops. Ask your doctor.
What if I accidentally swallow some of the eye drops?
Contact a doctor or poison control center right away.
How should I throw away the bottle when I'm done?
Ask your pharmacist how to properly dispose of the bottle.
What drug class is ketotifen ophthalmic?
ketotifen ophthalmic belongs to the Antihistamine / Mast Cell Stabilizer (Ophthalmic) drug class. It is available over the counter (OTC). These eye drops treat itchy eyes caused by allergies.
What pregnancy or breastfeeding source fields are listed for ketotifen ophthalmic?
The FDA label for ketotifen ophthalmic contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

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Medication Guides

What the FDA Data Shows for ketotifen ophthalmic

The FDA label for ketotifen ophthalmic (sold under brand names such as Zaditor, Alaway) classifies it as an over-the-counter product in the Antihistamine / Mast Cell Stabilizer (Ophthalmic) class. These eye drops treat itchy eyes caused by allergies. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $1.24 versus $0.86 for the brand.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: December 15, 2023

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page