Italian Medicines Agency Agenzia Italiana del Farmaco

Direct Healthcare Professional Communication (DHPC) - Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation - Direct Healthcare Professional Communication (DHPC) - Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation

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Direct Healthcare Professional Communication (DHPC) - Finasteride, dutasteride – New measures to minimise the risk of suicidal ideation

The use of finasteride, especially in 1 mg oral formulations for androgenetic alopecia, may be associated with suicidal ideation and depression, sometimes also related to sexual dysfunction. Patients should stop the treatment immediately and consult a doctor if they experience any of these symptoms. 

A patient card will be included in the 1 mg finasteride package to help patients recognize these symptoms and know how to act.

For dutasteride, although the available evidence is not sufficient to establish a direct association with suicidal ideation, based on the common mechanism of action of medicines belonging to the class of 5-alpha reductase inhibitors, it is recommended to pay attention and contact a doctor if mood changes occur. 


Published on: 16 September 2025

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