Legal status by country
Is Methotrexate legal?
Written by Aaron CuhaReviewed Sep 2026
How Methotrexate is classified in the United States, United Kingdom, Australia and Canada, side by side. Each country has its own page with a direct answer, the regulator's approval status and what the classification means in practice.
All four countries, side by side
| Attribute | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Approved | Approved | Approved |
| Classification | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Approved for rheumatoid arthritis, psoriasis and oncology indications. Requires monitoring of liver function and blood counts. No ageing indication. | None recorded | None recorded | None recorded |
US FDA status: FDA-approved for rheumatoid arthritis, psoriasis, and several cancers. Not approved for cardiovascular prevention or any ageing indication.. Reviewed Sep 2026.
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General information current as of Sep 2026, not legal advice. Classifications change; confirm with the regulator or a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships.