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Ketotifen: uses, dosing, side effects & brands

Ketotifen is a histamine-1 receptor inhibitor sold in the U.S. under 4 brand and generic names, for allergic conjunctivitis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Histamine-1 Receptor Inhibitor
Treats (across its forms)
Allergic Conjunctivitis
Available as
Drug-eluting contact lens · Drops · Solution
Sold as
4 products — Acuvue Theravision with Ketotifen, Alaway and Children's Alaway, and others
Prescription?
Both Rx and OTC forms
Generic available?
Not in our catalog
What the pharmacy pays
about $1 per ml — not your price

How Alaway is dosed

From the FDA label for Alaway (application NDA021996). Other ketotifen products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

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. Children under 3 years of age: consult a doctor

Every ketotifen product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Ketotifen products
#DrugRatingPharmacy pays
1Not yet rated$1View →
2Not yet rated$1View →
3Not yet rated$1View →
4Not yet rated$1View →

Ketotifen and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Because absorption from the eye is limited, ketotifen would not be expected to cause any adverse effects in breastfed infants after maternal use of ketotifen eye drops. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Full LactMed record for ketotifen: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised February 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about ketotifen

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,327 reports naming ketotifen, and the FDA flagged 49% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • treatment failure154 reports
  • pruritus128 reports
  • urticaria113 reports
  • nausea97 reports
  • fatigue93 reports
  • diarrhoea90 reports
  • headache90 reports
  • dyspnoea89 reports

Read these as a signal, not a rate. A report does not mean ketotifen caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

Related calculators

Frequently asked questions

What is Alaway?

Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

What kind of drug is ketotifen?

The FDA classifies ketotifen as a histamine-1 receptor inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take ketotifen with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ketotifen against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is ketotifen sold under?

We track 4 ketotifen-containing products in the U.S.: Acuvue Theravision with Ketotifen, Alaway, Children's Alaway and Zaditor. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does ketotifen come in?

Across the brands we track, ketotifen is currently marketed as drug-eluting contact lens, drops and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic ketotifen?

We do not currently list a generic-labelled ketotifen product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Ketotifen: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ketotifen
MLA
“Ketotifen: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ketotifen.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for ketotifen on DailyMed (NIH) ↗.