EMA-PRAC measures to minimize risk of suicidal thoughts with finasteride and dutasteride

8 May 2025

Following a European Union-wide review of available data on finasteride and dutasteride medicines, the European Medicines Agency’s (EMA) safety committee (PRAC) has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1mg and 5mg tablets but concluded that the benefits of finasteride and dutasteride medicines continue to outweigh their risks for all approved uses.

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