20.06.2025 - CMDh position

EMA recommends measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines.

The Agency confirms suicidal thoughts as side effect of finasteride tablets but found no direct link for dutasteride.

On 19 June 2025, the CMDh endorsed measures recommended by EMA’s safety committee, PRAC, to minimise the risk of suicidal ideation (suicidal thoughts) with finasteride and dutasteride medicines. Suicidal ideation was confirmed as a side effect of finasteride 1 and 5 mg tablets by the PRAC, following an EU-wide review of available data on these medicines. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.

08.05.2025 - PRAC recommendation

Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines

Suicidal thoughts confirmed as side effect of finasteride tablets; no direct link found for dutasteride

Following an EU-wide review of available data on finasteride and dutasteride medicines, EMA’s safety committee, PRAC, has confirmed suicidal ideation (suicidal thoughts) as a side effect of finasteride 1 and 5 mg tablets. The frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data.

04.10.2024 - procedure started

EMA started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviours.

For details regarding the procedure please click on the following link to the European Medicines Agency (EMA):