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.
Verify with FDA → · CMS NADAC pricing →
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 →
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.
How to Take It
For adults and children 3 years and older, put 1 drop in the affected eye(s). Do this twice a day, every 8 to 12 hours. Do not use it more than 2 times per day. For children under 3, ask your doctor.
This is a plain-language summary of ketotifen ophthalmic's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if ketotifen eye drops are safe to use during pregnancy or while breastfeeding. Talk to your doctor if you are pregnant or breastfeeding.
This is a plain-language summary of ketotifen ophthalmic's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, use it as soon as you remember. Then, continue with your regular schedule.
This is a plain-language summary of ketotifen ophthalmic's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature.
Common Questions
What is ketotifen?
How often can I use these eye drops?
Can children use these eye drops?
What if I wear contact lenses?
Can I use these eye drops for other eye problems?
What should I do if the itching gets worse?
How long does it take for the drops to work?
Can I use these with other eye drops?
What if I accidentally swallow some of the eye drops?
How should I throw away the bottle when I'm done?
What drug class is ketotifen ophthalmic?
Is ketotifen ophthalmic safe during pregnancy?
Related Medications in Antihistamine / Mast Cell Stabilizer (Ophthalmic)
Other drugs grouped near ketotifen ophthalmic - same-class peers and common alternatives.
azelastine
Astelin, Astepro
Azelastine nasal spray is an antihistamine medicine.
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budesonide nasal
Rhinocort
Rhinocort is a nasal spray that helps relieve allergy symptoms.
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cetirizine
Zyrtec
Cetirizine (Zyrtec) is an antihistamine medicine.
Compare with ketotifen ophthalmic →
chlorpheniramine
Chlor-Trimeton
Chlorpheniramine is an antihistamine medicine.
Compare with ketotifen ophthalmic →
ciclesonide nasal
Omnaris, Zetonna
Omnaris Nasal Spray is a medicine that helps treat allergy symptoms in your nose.
Compare with ketotifen ophthalmic →
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: December 15, 2023
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages