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.

The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.

Merck & Co’s (NYSE: MRK) Propecia and Proscar were the first two finasteride-containing medicines authorized in several countries of the European Union (EU). Dutasteride is marketed by Italy’s Recordati (RECI: MI) as Avodart, under license from originator, the UK’s GSK (LSE: GSK). Generic versions of both drugs are also available.

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