Is Danazol legal?
Written by Aaron CuhaReviewed Sep 2026
- US: FDA-approved, prescription only
- UK: Licensed, prescription only (MHRA)
- AU: TGA-registered, prescription only
- CA: Health Canada approved, prescription only
The US comes first because most people ask about it. Each country has its own page. It names the agency, the law or rule, and what the legal category means in real life.
All four countries, side by side
| What we list | United States · FDA | United Kingdom · MHRA | Australia · TGA | Canada · Health Canada |
|---|---|---|---|---|
| Status | Approved | Approved | Approved | Approved |
| Legal category | FDA-approved, prescription only | Licensed, prescription only (MHRA) | TGA-registered, prescription only | Health Canada approved, prescription only |
| Note | Approved with a boxed warning, the FDA's strongest kind. It covers use in pregnancy, blood clots, blood-filled pockets in the liver (peliosis hepatis) and raised pressure inside the skull that is not caused by a tumour. Use for telomeres or ageing is off label. | A licensed prescription medicine. Its use for telomeres is not licensed anywhere. | None recorded | None recorded |
| Agency | Check FDA directly | Check MHRA directly | Check TGA directly | Check Health Canada directly |
US FDA status: FDA approved for endometriosis, lumpy (fibrocystic) breast disease and hereditary angioedema, an inherited swelling disorder. It carries a boxed warning, the FDA's strongest kind. Not approved for telomere disease, ageing or any longevity use. Its use in inherited telomere diseases is off label, and it was studied under an investigational plan.. Reviewed Sep 2026.
Country by country
Is Danazol legal in the United States?
Yes. Danazol is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full United States answerIs Danazol legal in the United Kingdom?
Yes. Danazol is an approved medicine in the United Kingdom. Its legal category is "Licensed, prescription only (MHRA)". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full United Kingdom answerIs Danazol legal in Australia?
Yes. Danazol is an approved medicine in Australia. Its legal category is "TGA-registered, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full Australia answerIs Danazol legal in Canada?
Yes. Danazol is an approved medicine in Canada. Its legal category is "Health Canada approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 3 completed human trials are cited on its profile.
The full Canada answerDanazol in sport and the military
Whether Danazol is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status. Before you compete or get tested, look up Danazol by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
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General information, current as of Sep 2026. Not legal advice. Legal status changes. For your own situation, check with the agency or a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.