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Dutasteride: Effects, Evidence and Risks

Also known as Avodart, Duodart (with tamsulosin), Zagallo (Japan), generics.

StatusApproved (EU)
EvidenceLarge RCTs
Drug class5-alpha-reductase inhibitor (types 1 and 2) · soft capsule
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We only show doses for approved medicines according to the prescribing information – in the calculator.

What is Dutasteride?

Dutasteride inhibits both forms of 5-alpha-reductase and lowers DHT even more strongly than finasteride. In the EU it is used for benign prostatic hyperplasia; for hair loss it is prescribed only off-label here.

How well studied is Dutasteride?

Large pivotal trials exist for prostate enlargement. For male hair loss, a global phase II/III trial with 917 participants showed higher hair counts than placebo and non-inferiority to finasteride; this is the basis for approval in this indication in Japan (2015) and South Korea.

What side effects and risks does Dutasteride have?

Similar to finasteride: libido and erectile problems, breast enlargement, reduced sperm count, lower PSA. Its very long half-life (weeks) means side effects can persist after stopping, and blood should not be donated for a period after treatment ends. Pregnant women must not touch leaking capsules (risk of malformation).

Is Dutasteride approved in Germany?

In short: yes. Approved and prescription-only in Germany – only for benign prostatic hyperplasia; hair-loss treatment is off-label (approved in Japan/South Korea). The 2025 EMA review found no direct link to suicidal thoughts, but warnings were still added. To current knowledge not on the WADA Prohibited List; counterfeit risk with prescription-free online offers.

Sources

Note: We deliberately do not list any doses here. For approved medicines, your doctor sets the dose; for unapproved substances there is no reliable information.