What Schedule Is Ketotifen?
Ketotifen scheduling and classification across Australia, United States, and international jurisdictions. Also known as ZADITEN ketotifen 250microgram/mL eye drops bottle, ZADITEN ketotifen 250microgram/mL eye drops, solution ampoule, AMCAL ALLERGY RELIEF EYE DROPS ketotifen (as fumarate) 250 microgram/mL bottle.
Ketotifen (ZADITEN ketotifen 250microgram/mL eye drops bottle) is classified as S3 (Pharmacist Only Medicine - available without a prescription but requires pharmacist involvement and may require consultation) under the Therapeutic Goods Administration (TGA) in Australia. It is FDA approved in the United States.
Key Takeaways
- Australia (TGA): S3 - Pharmacist Only Medicine - available without a prescription but requires pharmacist involvement and may require consultation
- United States (FDA): Approved (Rx only)
- Risk level: Low (1 points)
Scheduling by Jurisdiction
| Jurisdiction | Regulatory Body | Classification | Status |
|---|---|---|---|
| Australia | TGA (Therapeutic Goods Administration) | S3 | Not PBS listed |
| United States | FDA / DEA | Rx only (not DEA scheduled) | FDA approved |
What S3 Means for Ketotifen
Ketotifen is classified as S3 under the TGA Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). Pharmacist Only Medicine - available without a prescription but requires pharmacist involvement and may require consultation.
Claims and Workers Compensation Implications
When Ketotifen (S3) appears on a claimant's medication list, the scheduling classification affects how claims professionals should assess and manage the claim.
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Related Resources
Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.