MHRA Alert – Finasteride and Dutasteride: Updated Psychiatric and Sexual Dysfunction Warnings

Updated Safety Warnings for Finasteride and Dutasteride

The MHRA has completed a review of finasteride and dutasteride, two commonly prescribed medications for benign prostatic hyperplasia and male-pattern hair loss, and has identified important new safety information regarding psychiatric side effects and sexual dysfunction.

Key Points

• The MHRA has reviewed evidence linking finasteride and dutasteride to suicidal thoughts and behaviours
• Updated safety warnings and risk-minimisation measures have been recommended
• Healthcare providers and patients should be aware of psychiatric symptoms as potential adverse effects
• Sexual dysfunction remains a documented risk with these medications

Affected Medications

• Finasteride (including branded products such as Propecia and Proscar)
• Dutasteride (including branded products such as Avodart)

Recommended Actions

All clinicians prescribing or managing patients on finasteride or dutasteride should:

• Review the full MHRA safety update for detailed guidance on psychiatric monitoring and patient counselling
• Ensure informed consent conversations include discussion of psychiatric risks and sexual dysfunction
• Advise patients to report any mood changes, suicidal ideation, or other concerning symptoms immediately
• Consider baseline mental health assessment where appropriate, particularly in patients with a history of psychiatric illness

Further Information

For the complete MHRA safety update, including detailed clinical guidance and pharmacovigilance data, visit the MHRA Drug Safety Update.