FDA-filed SPL labeling · retrieved through openFDA

Ketotifen

Ketotifen is an antihistamine eye treatment used to temporarily relieve itchy eyes caused by allergies — available as eye drops and, in the case of ACUVUE Theravision with Ketotifen, as a daily contact lens that also corrects vision.

Brand names Wal-Zyr Itchy EyeZaditorAlawayClaritin EyeEye Itch Relief +7 more
Drug classes ⓘ Histamine H1 Receptor Antagonists
Rx/OTC Form 1 Routes Ophthalmic · Intraocular
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 →

At a glance
Linked label effectiveMar 25, 2026
Clinical labels in scope ⓘ38
AvailabilityRx/OTC
Earliest approval/marketing year ⓘ1999
FDA-listed product records ⓘ71
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 23, 2026
Other forms & routes:
Ophthalmic
⭐ Ketotifen at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Ketotifen is a well-established antihistamine used in the eye to relieve or prevent allergic eye itch caused by common triggers like pollen and pet dander. Eye drops are used twice daily and are appropriate for adults and children 3 and up, while ACUVUE Theravision with Ketotifen is a specialized daily contact lens that combines allergy itch prevention with vision correction. Follow your prescriber's or eye care professional's guidance and stop use if you notice increasing eye pain, vision changes, or redness.
How we write & review this content — our editorial policy →

📖 Ketotifen: Patient Information Guide

A plain-language walkthrough of Ketotifen — 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▾

Ketotifen is an antihistamine used in the eye to fight allergy-related itch. It's available in several forms across multiple products.

  • Alaway, Allergy Eye Drops, Equate Eye Itch Relief, Eye Itch, and other ketotifen ophthalmic drops temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander.
  • ACUVUE Theravision with Ketotifen — a daily wear, daily disposable drug-eluting contact lens — is specifically indicated to prevent eye itch due to allergic conjunctivitis and to correct refractive ametropia (nearsightedness and farsightedness) in suitable contact lens wearers who do not have red eyes and have no more than 1 diopter of astigmatism.
⚙️How it works▾

Ketotifen blocks H1 histamine receptors in the eye — the targets that trigger allergic itch when you're exposed to allergens like pollen or pet dander. It also stabilizes mast cells (immune cells that release itch-causing chemicals) and helps prevent eosinophils (another type of immune cell) from accumulating in the eye. By acting on both of these pathways, it stops the allergic itch response before it takes hold.

In the ACUVUE Theravision with Ketotifen contact lens, the drug is built into the lens itself and releases gradually while worn on the eye. This allergy-preventing effect has been shown to last through 12 hours in clinical trials.

💊How it's taken▾

How you use ketotifen depends on which product you have.

  • Eye drops (Alaway, Allergy Eye Drops, Equate Eye Itch Relief, Eye Itch, and others): Adults and children 3 and older apply 1 drop in the affected eye(s) twice daily, every 8 to 12 hours — no more than twice per day. Children under 3 should see a doctor first. If you use other eye products, wait at least 5 minutes between them.
  • ACUVUE Theravision with Ketotifen contact lens: Insert one lens per eye each day. Remove before sleeping and throw it away — it's single-use only. Your eye care professional will set your maximum wearing time. Do not use eye drops or medications containing benzalkonium chloride while wearing these lenses; if you need to apply eye drops, wait at least 10 minutes before inserting the lens.
🤒Side effects — in detail▾

Most people tolerate ketotifen eye products well. The most commonly reported side effects in clinical studies of ACUVUE Theravision with Ketotifen were:

  • Eye irritation
  • Eye pain
  • Irritation at the lens insertion site

Stop using the product and contact your doctor or eye care professional right away if you develop eye pain, changes in vision, increasing redness, or itching that doesn't improve or lasts beyond 72 hours — these may signal a more serious problem.

⚠️Warnings & precautions▾
  • Corneal ulcers and eye infections: Do not insert ACUVUE Theravision lenses if you have a corneal ulcer, corneal infection (bacterial, fungal, protozoal, or viral), dry eye disease, or any injury or abnormality of the eye or eyelids. Contact lens wear can worsen these conditions and threaten your sight.
  • Red or irritated eyes: ACUVUE Theravision with Ketotifen should not be inserted into red or irritated eyes. Remove the lens immediately if your eye becomes red or irritated.
  • Swimming and water exposure: Do not wear ACUVUE Theravision lenses while swimming or in hot tubs. Never rinse them with tap water. These actions raise the risk of serious eye infections.
  • Chemical splashes: If any chemical gets in your eyes, flush immediately with water and get emergency care right away — do not delay.
  • Smokers: Contact lens wearers who smoke have a higher rate of corneal ulcers than non-smokers.
  • Eye drops: Do not use ketotifen eye drops to treat contact lens-related irritation. Always remove lenses before applying drops and wait at least 10 minutes before reinserting them.
🔀What it interacts with▾

There are limited drug interactions with ketotifen eye products, but one important one to know about:

  • Benzalkonium chloride-containing eye drops or medications: These should not be used at the same time as ACUVUE Theravision with Ketotifen lenses. If you need to use such a product, apply the drops first and wait at least 10 minutes before inserting the lens — benzalkonium chloride can damage the lens.

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 ketotifen eye drops if you are allergic to any ingredient in the product, or if the solution has changed color or turned cloudy.
  • Do not use the eye drops to treat irritation caused by contact lenses.
  • ACUVUE Theravision with Ketotifen is contraindicated in patients with red or irritated eyes (ocular hyperemia), decreased corneal sensation (corneal hypoesthesia), or any active corneal infection.
  • The safety and effectiveness of ACUVUE Theravision with Ketotifen have not been established in children under 11 years of age.
  • Children under 3 years of age should not use ketotifen eye drops without consulting a doctor.
  • There is limited data on use of ACUVUE Theravision with Ketotifen in adults 65 and older.
  • If you are pregnant: ACUVUE Theravision with Ketotifen is not expected to be absorbed into the body in meaningful amounts through the eye, so fetal exposure is unlikely — but no adequate human studies exist. Talk to your doctor.
  • If you are breastfeeding: It is not known whether ketotifen from eye use passes into breast milk in detectable amounts. Discuss the benefits and risks with your doctor.
📡Pharmacodynamics — effects in the body▾

Ketotifen blocks H1 histamine receptors in the eye and stabilizes mast cells, preventing the release of histamine and other allergy-triggering chemicals. It also inhibits the buildup of eosinophils — immune cells involved in allergic reactions — in eye tissue. In clinical studies of the ACUVUE Theravision contact lens, this itch-preventing effect was demonstrated to last through 12 hours of lens wear.

📦How to store it▾

Store at 20° to 25°C (68° TO 77°F) .

📄 Written from Ketotifen’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 Ketotifen — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does ketotifen do for my eyes? ▾
Ketotifen blocks the histamine receptors in your eye that cause itching when you're exposed to allergens like pollen, pet dander, or grass. It also calms down the immune cells that release those itch-causing chemicals in the first place. The result is that your eyes stop itching — or are less likely to start itching if you use it preventatively, as with the ACUVUE Theravision contact lens.
How often do I use the eye drops, and can I use them with contacts in? ▾
You use ketotifen eye drops twice a day, about every 8 to 12 hours — no more than two times daily. Always remove your contact lenses before putting in the drops, and wait at least 10 minutes before putting your lenses back in. If you're using other eye drops too, wait at least 5 minutes between products.
What's different about the ACUVUE Theravision contact lens compared to the eye drops? ▾
ACUVUE Theravision with Ketotifen is a daily disposable contact lens that has the medication built right into it, so it releases ketotifen throughout the day while you're wearing it — no separate eye drops needed for allergy relief. It also corrects your vision at the same time. It's designed for people who are good candidates for contact lenses, don't have red eyes, and have minimal astigmatism. You insert one lens per eye each morning and throw it away at the end of the day — never sleep in it.
When should I stop using ketotifen and call a doctor? ▾
Stop using the drops and call your doctor if your itching gets worse or lasts more than 72 hours, if you notice eye pain, if your vision changes, or if your eyes become red. If you're using the ACUVUE Theravision lens, remove it immediately if your eye becomes red, painful, or uncomfortable, and contact your eye care professional right away. Any chemical splash to the eye is a 911-level emergency — flush with water and go to the ER without delay.
Can I use ketotifen eye drops if I'm pregnant or breastfeeding? ▾
The ACUVUE Theravision with Ketotifen lens is not expected to be absorbed into your body in significant amounts through the eye, so the risk to a developing baby is considered very low. That said, there are no solid human studies to confirm safety, and it's not clear whether any ketotifen gets into breast milk from eye use. It's always worth mentioning to your doctor so you can decide together what's best for you and your baby.
Can children use ketotifen eye drops? ▾
Yes — ketotifen eye drops are approved for children 3 years and older, using the same dose as adults: one drop in the affected eye(s) twice a day. For children under 3, you'll need to check with a doctor first. The ACUVUE Theravision contact lens has not been studied in children under 11, so it's not recommended for that age group.
Is Ketotifen available over the counter? ▾
Both — Ketotifen is sold both over the counter and by prescription, according to its FDA labeling. Lower strengths or certain forms are often available without a prescription, while higher strengths or specialized forms still require one. Ask your pharmacist which version is right for you.
When was Ketotifen first available? ▾
Ketotifen has been available in the United States since at least 1999, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Ketotifen? ▾
Ketotifen is supplied by 39 manufacturers listed in the FDA NDC Directory, including CVS Pharmacy, Rite Aid Corporation, A-S Medication Solutions.

💬 Answers drafted from Ketotifen’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

🌿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

💊 How Ketotifen 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, Allergy Eye Drops, Equate Eye Itch Relief, and Eye Itch eye drops temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander
  • ACUVUE Theravision with Ketotifen is a drug-eluting daily contact lens used to prevent eye itch due to allergic conjunctivitis and to correct nearsightedness or farsightedness
Important instructions
  • Alaway, Allergy Eye Drops, Equate Eye Itch Relief, and Eye Itch drops: adults and children 3 years and older apply 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day; children under 3 should consult a doctor
  • If using other eye products with Alaway, Allergy Eye Drops, Equate Eye Itch Relief, or Eye Itch drops, wait at least 5 minutes between each product
  • ACUVUE Theravision with Ketotifen: insert one lens per eye per day; remove before sleeping and discard after a single day's use
  • ACUVUE Theravision with Ketotifen: do not use eye drops or medications containing benzalkonium chloride at the same time — wait at least 10 minutes after any eye drop application before inserting the lens
Available strengths 3 strengths
0.019 mg 0.25 mg/mL 0.35 mg/mL
62 FDA-listed product records ⓘ

📊 Ketotifen across the U.S. market

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.

1
Dose forms ⓘ
39
Manufacturers
12
Brand names
71
FDA-listed product records ⓘ
1999
First marketed ⓘ

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

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 1,596 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 1,596
#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 →

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.

🏷️ Sold under these brand names

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

🏭 Manufacturers & labelers

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.

🔬 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.

📄
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 we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 38 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.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Walgreen Company 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.