Skip to the answer

Ketotifen

Ketotifen is an antihistamine used in the eye to relieve or prevent itching caused by allergies, found in over-the-counter eye drops and in a drug-eluting contact lens.

Brand names Wal-Zyr Itchy EyeZaditorAlawayClaritin EyeEye Itch Relief +7 more
Drug classes Histamine H1 Receptor Antagonists
Rx/OTC Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 38 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 →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 3, 2026
Other forms & routes:
Ophthalmic
Ketotifen at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ketotifen is an antihistamine that also steadies mast cells (immune cells that release allergy chemicals), so it both relieves and helps prevent itchy eyes from pollen, grass and pet dander. It has been on the market since about 2006 and is available generically, and the drops are a common first pick at the pharmacy. A daily contact lens (ACUVUE Theravision) also delivers it while correcting vision. Most people tolerate it well, and the usual complaint is mild eye irritation. Stop the drops and see a doctor if you get eye pain, vision changes, redness, or itching that worsens or lasts more than 72 hours.

Clinical pearls

  • Take contacts out before using the drops and wait at least 10 minutes to put them back in.
  • The drops treat allergy itch, not lens-related irritation, so do not use them for sore eyes from contacts.
  • Stick to twice a day, every 8 to 12 hours, and have a doctor check children under 3 first.
  • With the Theravision lens, avoid eye drops containing benzalkonium chloride, a common preservative, and never rinse the lens in tap water.
How we write & review this content — our editorial policy →
How you get itPrescription and over the counter
Comes asEye drops
Earliest FDA record1999
Companies listing it with the FDA39
FDA label last updatedMar 25, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Ketotifen, written from its FDA label.

What Ketotifen is used for

▾

Ketotifen is used for allergic eye itch, but the uses differ by product.

  • Ketotifen eye drops (such as Alaway, Eye Itch Relief, Equate Eye Itch Relief, Allergy Eye Drops, Eye Itch and Zaditor) temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander.
  • ACUVUE Theravision with Ketotifen, a daily disposable contact lens, prevents ocular itch due to allergic conjunctivitis.
  • ACUVUE Theravision with Ketotifen also corrects myopia (nearsightedness) and hyperopia (farsightedness) in people without red eyes who are suitable for contact lens wear and have no more than 1 D of astigmatism.

How Ketotifen works

▾

Ketotifen blocks H1 histamine receptors, the spots that histamine acts on to cause itching. It also stabilizes mast cells so they release fewer allergy chemicals. It prevents eosinophils from building up as well.

This stops allergic eye itch from starting. With the lens, it allows continued wear during allergen exposure. Itch prevention has been shown to last through 12 hours in clinical trials.

Ketotifen dosage

▾

Dosing depends on the product.

  • Eye drops: adults and children 3 years and older use 1 drop in each affected eye twice daily, every 8 to 12 hours, and no more than twice a day. Children under 3 should see a doctor.
  • If you use other eye products, wait at least 5 minutes between them.
  • ACUVUE Theravision with Ketotifen lens: one lens per eye per day, thrown away after one day. Remove it before sleeping.
  • Your eye care professional decides your maximum daily wearing time.

Dosing details from the FDA-approved label

From the Ketotifen prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • ACUVUE Theravision with Ketotifen drug-eluting contact lens (general dosing)
    • Insert one lens per eye per day
    • Discard lens after a single day's use
    • Lenses should be removed prior to sleeping
    • The maximum daily wearing time should be determined by the Eye Care Professional based upon the patient's individual response to contact lenses.
  • Ketotifen ophthalmic solution: adults and children 3 years and older
    • Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
    • Maximum: no more than twice per day
    • If using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • Ketotifen ophthalmic solution: children under 3 years of age
    • Consult a doctor
Read the label’s full dosing text

Directions • adults and children 3 years and older: • put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • children under 3 years of age: consult a doctor Other information store at 4-25 °C (39-77 °F)

Read the full Dosage and Administration section on DailyMed →

Ketotifen side effects

▾

Common side effects

  • Eye irritation (reported with the ACUVUE Theravision with Ketotifen lens)
  • Eye pain (reported with the ACUVUE Theravision with Ketotifen lens)
  • Pain or irritation when the lens is put in (reported with the ACUVUE Theravision with Ketotifen lens)

When to get medical help

  • Stop the eye drops and ask a doctor if you have eye pain.
  • Stop the eye drops and ask a doctor if your vision changes.
  • Stop the eye drops and ask a doctor if your eyes become red.
  • Stop the eye drops and ask a doctor if itching gets worse or lasts more than 72 hours.
  • If you wear the ACUVUE Theravision lens and have eye discomfort, excessive tearing, vision changes or redness, remove the lens right away and contact your eye care professional.
  • If chemicals splash into your eyes, flush them with water right away and contact your eye care professional or go to the emergency room.
  • If the eye drops are swallowed, get medical help or contact Poison Control right away.

The lens studies reported these most often:

  • Eye irritation
  • Eye pain
  • Pain or irritation when the lens is inserted

Stop use and get help for eye pain, vision changes, redness, or itching that worsens or lasts more than 72 hours.

Ketotifen warnings and precautions

▾
  • The eye drops are for external use only. Do not touch the bottle tip to any surface.
  • Do not use the drops if the solution changes color or turns cloudy.
  • Do not use the drops to treat contact lens-related irritation.
  • ACUVUE Theravision with Ketotifen should not be used to treat or prevent lens-related irritation, discomfort or redness.
  • Overnight lens wear raises the risk of corneal ulcers, and smokers have a higher risk.
  • Do not wear the lens while swimming or in hot tubs, and do not rinse it in tap water.
  • If chemicals splash in your eyes, flush with water right away and get medical help.
  • Keep a working pair of glasses available, and tell your employer if you wear contacts when eye protection may be needed.

Ketotifen interactions

▾

The main cautions involve other eye products.

  • Other eye products used with the drops: wait at least 5 minutes between each one.
  • Eye drops or medicines containing benzalkonium chloride: do not use at the same time as the ACUVUE Theravision lens.
  • Eye drops with the lens: wait at least 10 minutes after applying drops before inserting lenses.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Ketotifen against a supplement or herb →

Before taking Ketotifen

▾
  • Do not use the drops if you are sensitive to any ingredient.
  • Remove contact lenses before using the drops, and wait at least 10 minutes before reinserting them.
  • ACUVUE Theravision with Ketotifen is not for people with red or irritated eyes, reduced corneal sensation, or a corneal infection.
  • It should also not be inserted with corneal ulcers, dry eye disease, or eyelid or front-of-eye injury or abnormality.
  • Pregnancy: there are no adequate studies of the lens in pregnant women. The lens is not absorbed systemically, so fetal exposure is not expected.
  • Breastfeeding: it is not known if enough drug reaches breast milk from eye use. Discuss with your doctor.
  • Children: the lens has not been shown safe and effective under 11 years. Children under 3 should see a doctor before using the drops.
  • Older adults: studies did not include enough people 65 and over to say whether they respond differently.

Ketotifen overdose

▾

If the eye drops are swallowed, get medical help or contact a Poison Control Center right away.

How to store Ketotifen

▾

Store at 20° to 25°C (68° TO 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Ketotifen: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ketotifen — the kind of thing our pharmacy team would talk through with you at the counter.

What is ketotifen used for?

▾
It relieves or prevents itchy eyes from allergies. The drops give temporary relief from itching due to pollen, ragweed, grass, and animal hair and dander. The ACUVUE Theravision lens is a separate product that prevents allergic eye itch and also corrects your vision.

How often can I use the eye drops?

▾
If you are an adult or a child 3 or older, use 1 drop in each affected eye twice a day, 8 to 12 hours apart. Don't use them more than twice daily. If your child is under 3, check with a doctor first.

Can I wear my contacts with the drops?

▾
Take your contact lenses out before using the drops. Then wait at least 10 minutes before putting them back in. If you use other eye products too, leave at least 5 minutes between them.

When should I stop and call someone?

▾
Stop the drops and talk to a doctor if you have eye pain, changes in vision, redness, or itching that gets worse or lasts more than 72 hours. With the ACUVUE Theravision lens, take it out right away for discomfort, redness, excess tearing, or vision changes, and call your eye care professional.

Any tips for the ACUVUE Theravision lens?

▾
Use a fresh lens each day and take it out before sleeping. Don't wear it swimming or in hot tubs, and don't rinse it with tap water. Keep glasses handy in case you can't wear your lenses.

Is it safe in pregnancy?

▾
For the ACUVUE Theravision lens, there are no adequate studies in pregnant women. The drug is not absorbed into the body from the lens, so exposure to the baby is not expected. Check with your doctor to be sure, especially if you are pregnant or breastfeeding.

Is Ketotifen available over the counter?

▾
Both. Some Ketotifen products are sold over the counter and others need a prescription. According to their FDA listings, the eye drops form is sold both ways, at different strengths or package sizes. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Ketotifen first available?

▾
The earliest FDA record we hold for Ketotifen is from 1999: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ketotifen was first used.

Who makes Ketotifen?

▾
39 companies list Ketotifen products in the FDA's NDC Directory, including CVS Pharmacy, Rite Aid Corporation, A-S Medication Solutions. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ketotifen on HelloPharmacist

🌿Drug & Supplement CheckerKetotifen vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ketotifen NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ketotifen Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ketotifen forms and strengths (how it comes)

Ketotifen 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

In the eye
Brands ACUVUE Theravision with Ketotifen Alaway Alaway Preservative Free Allergy Eye Drops Equate Eye Itch Relief Eye Itch Eye Itch Releif Eye Itch Relief Itchy Eye Zaditor
How this form is used
What it may be used for
  • Alaway, Equate Eye Itch Relief, Allergy Eye Drops and Eye Itch temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander.
  • ACUVUE Theravision with Ketotifen is a daily disposable contact lens that prevents eye itch from allergic conjunctivitis and corrects nearsightedness and farsightedness.
Important instructions
  • Alaway, Equate Eye Itch Relief, Allergy Eye Drops and Eye Itch: adults and children 3 and older use 1 drop in each affected eye twice daily, every 8 to 12 hours.
  • Alaway: wait at least 5 minutes between other eye products.
  • ACUVUE Theravision with Ketotifen: use one lens per eye per day, discard after one day, and remove before sleeping.
  • ACUVUE Theravision with Ketotifen: do not use eye drops containing benzalkonium chloride with the lens.
Available strengths 3 strengths
0.019 mg 0.25 mg/mL 0.35 mg/mL
62 FDA-listed product records ⓘ

Ketotifen on the U.S. market: products, makers and brands

How Ketotifen 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.

39 companies list 71 Ketotifen product records with the FDA, mostly as eye drops; the earliest marketing or approval year on record is 1999. Brand names on the directory include Wal-Zyr Itchy Eye, Zaditor, Alaway and 9 more; the rest are generics.

1
Dose forms ⓘ
39
Labelers (makers, repackagers, distributors)
12
Brand names
71
FDA-listed product records ⓘ
1999
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (9) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

CVS Pharmacy11%
Rite Aid Corporation6%
A-S Medication Solutions6%
Rugby Laboratories6%
Cardinal Health4%
Kroger Company4%
Other makers63%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Ketotifen is used (Medicaid data)

A general measure of how commonly Ketotifen 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 Ketotifen 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.

714,559
Medicaid prescriptions filled (Q1–Q4 2025)
$12M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ketotifen prescribed? Of the 1,599 medications we measure, Ketotifen ranks #216 by Medicaid prescriptions — more than 86% of them.

Where Ketotifen ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #216 of 1,599
#211 Lacosamide 735,538 Rx #212 Acyclovir 733,721 Rx #213 Testosterone 731,644 Rx #214 Progesterone 725,527 Rx #215 Sucralfate 724,768 Rx #216 Ketotifen Ophthalmic 714,559 Rx #217 Ketotifen 714,559 Rx #218 Metoclopramide 712,920 Rx #219 Ofloxacin Otic 706,749 Rx #220 Guaifenesin 701,387 Rx #221 Hydroxychloroquine 696,525 Rx

Utilization by Ketotifen 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.

ketotifen 0.25 MG/ML Ophthalmic Solution

714,559 Medicaid prescriptions (Q1–Q4 2025) 100% of Ketotifen prescriptions shown $12M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 9 of 60 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 311237

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 Ketotifen, 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 9 of 60 listed Ketotifen NDCs with Medicaid activity.

Compare Ketotifen products

A representative set of FDA-listed product records for Ketotifen — 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.)

Showing 71 of 71 products — FDA National Drug Code Directory. See every product, package size and price: browse all 71 Ketotifen NDCs →

Ketotifen 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.

The FDA’s enforcement reports list one Ketotifen recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Class II Jun 29, 2022 · Terminated · Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
  • Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011… Lots: Part# 0065401105 FDA record D-1317-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

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.

Ingredient (IN) Ketotifen RxCUI 6146 4 dose forms · 4 strengths
  1. Dose form (SCDF) Ophthalmic Solution RxCUI 372550 In current FDA listings
    Clinical drug / strength (SCD) 0.25 MG/ML RxCUI 311237
  2. Dose form (SCDF) Oral Capsule RxCUI 372548 No current FDA listing
    Clinical drug / strength (SCD) 1 MG RxCUI 250435
  3. Dose form (SCDF) Oral Solution RxCUI 372549 No current FDA listing
    Clinical drug / strength (SCD) 0.2 MG/ML RxCUI 246129
  4. Dose form (SCDF) Oral Tablet RxCUI 372552 No current FDA listing
    Clinical drug / strength (SCD) 1 MG RxCUI 246127

Look up RxCUI 6146 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.

Ketotifen brand names

Ketotifen is sold under 12 brand names in the FDA directory — Wal-Zyr Itchy Eye, Zaditor, Alaway, Claritin Eye and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Wal-Zyr Itchy Eye Zaditor Alaway Claritin Eye Eye Itch Relief Eye Itch Eye Itch Releif ACUVUE Theravision with Ketotifen Alaway Preservative Free Allergy Eye Drops Equate Eye Itch Relief Itchy Eye

Who makes Ketotifen: manufacturers and labelers

39 companies list Ketotifen products with the FDA. By number of product records, the largest are CVS Pharmacy, Rite Aid Corporation, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

CVS Pharmacy 8 Rite Aid Corporation 4 A-S Medication Solutions 4 Rugby Laboratories 4 Cardinal Health 3 Kroger Company 3 Target Corporation 3 Bausch & Lomb Incorporated 2 Safeway 2 Walgreen Company 2 Alcon Laboratories, Inc. 2 Direct Rx 2 H E B 2 Preferred Pharmaceuticals Inc. 2 Topco Associates Llc 2 Strategic Sourcing Services Llc 2 Meijer Distribution Inc 2 Sentiss Pharmaceuticals LLC 1 Unichem Pharmaceuticals (USA), Inc. 1 Spectrum Laboratory Products, Inc. 1 Perrigo Direct Inc. 1 Wal-Mart Stores, Inc. 1 Walgreens 1 Zhejiang Huahai Pharmaceutical Co., Ltd. 1

…and 15 more on the FDA NDC directory.

Ketotifen drug class (RxNorm)

Ketotifen belongs to the Histamine-1 Receptor Inhibitor class.

Pharmacologic class Histamine-1 Receptor Inhibitor
Drug family (ATC) Other antihistamines for systemic use, Other antiallergics
How it works Histamine H1 Receptor Antagonists

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.

Sources for this Ketotifen page

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 25, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ketotifen.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ketotifen after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
38
NDC products indexed
71
Distinct labelers/manufacturers represented
39
Linked representative label ⓘ
Walgreen Company
Linked label effective
Mar 25, 2026
Composite sections available
9
Linked SPL Set ID
9ce8f926-c202-40d1-9dba-0477f1f49e14
Linked SPL Document ID
4ddfb3f8-812d-c7c4-e063-6394a90a284d
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Walgreen Company is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →