Ketotifen
Active ingredient · 2 therapeutic classes
Sold as ZADITEN · ZADITOR
- Drug class
- Other Antihistamines For Systemic Use
- Availability
- Over-the-counter
- Routes
- Ophthalmic, Oral
- Markets covered
- 3
- Products on record
- 14
Overview
Ketotifen is an active pharmaceutical ingredient in the Other Antihistamines For Systemic Use group (R06AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 7 | May 22, 2026 |
| CA Canada | Health Canada | 5 | May 23, 2025 |
| US United States | FDA | 2 | November 24, 2025 |
GBUnited Kingdom· MHRA
7 products
Uses
Symptomatic treatment of seasonal allergic conjunctivitis.
How to take
CACanada· Health Canada
5 products
Uses
Zaditen (ketotifen hydrogen fumarate) is indicated as an add-on medication for the chronic treatment of mild atopic asthma in children 5 years and older. Zaditen is not indicated for the relief of acute bronchospasm (see General). 1 Pediatrics Pediatrics (< 5 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for Zaditen tablets for pediatric use in children < 5 years of age.
Pediatrics (5 to < 18 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of Zaditen in pediatric patients 5 to < 18 years of age has been established. Therefore, Health Canada has authorized an indication for pediatric use.
2 Geriatrics Geriatrics: No data are available to Health Canada; therefore, Hea lth Canada has not authorized an indication for geriatric use.
USUnited States· FDA
2 products
Uses
Uses For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.
How to take
Drug interactions
Known interactions involving Ketotifen. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL409340001 · revised March 20, 2026
- [2]Health Canada (DPD) · 00577308 · revised March 22, 2025
- [3]FDA DailyMed · 1234de19-257c-42… · revised May 11, 2023 [PDF]
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.