MHRA strengthens safety warnings for finasteride and dutasteride

Updated safety advice has been issued to strengthen warnings about potential psychiatric and sexual dysfunction linked to finasteride and to provide precautionary advice on dutasteride.

Following an additional detailed review of the evidence, including the outcome of a European regulatory review, the MHRA has published a new Drug Safety Update and is updating product information for medicines containing finasteride and dutasteride to provide clearer guidance for healthcare professionals and patients. 

Finasteride is used to treat male pattern hair loss at a dose of 1mg, and benign prostatic hyperplasia at a dose of 5mg. Dutasteride (0.5mg) is used to treat benign prostatic hyperplasia. 

The updates include: 

• strengthened warnings in the product information for finasteride 1mg for androgenetic alopecia to clarify that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has also been reported with and without mood alterations.
• a precautionary warning added to the product information for dutasteride to note that mood alterations have been reported with a medicine in the same class, finasteride.

Existing UK patient alert cards for finasteride, introduced in 2024, remain in place. These cards highlight the risks of sexual dysfunction, depression and suicidal thoughts and advise patients on what action to take if side effects occur. 

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Source: MHRA, 11 May 2026