MHRA Drug Safety Update: Finasteride and Dutasteride – updated safety warnings

The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.

The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk. The product information for finasteride and dutasteride containing medicines is being updated to provide more information on these side effects. The UK Finasteride patient cards, already introduced in 2024, highlight the risks of psychiatric and sexual side effects.

Advice for Healthcare Professionals

• finasteride is associated  with depression, suicidal ideation and sexual dysfunction which may persist after treatment is stopped
• inform patients of the risks at point of prescribing and advise patients to read the Finasteride patient cards  and the patient leaflet for finasteride which are both supplied in the 1 mg and 5 mg packs
• the product information for finasteride 1 mg will be updated with a warning that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has also been reported without mood alterations
• when prescribing finasteride, review their medical record, ask patients if they have a history of depression or suicidal ideation and review patients regularly for psychiatric and/or sexual side effects
• patients prescribed finasteride 1 mg should stop taking the medicine if they develop suicidal thoughts or depression and contact their healthcare professional  as soon as possible
• patients prescribed finasteride 5mg or dutasteride should consult their healthcare professional as soon as possible if they develop suicidal thoughts or depression
• dutasteride works in a similar way to finasteride – therefore, as a precaution, a warning will be added to the dutasteride product information that mood alterations have been reported with the same class of medicine (finasteride)
• patients prescribed finasteride or dutasteride should contact their healthcare professional if they experience sexual dysfunction
• report suspected adverse drug reactions associated with finasteride or dutasteride using the Yellow Card scheme

Advice for Healthcare Professionals to Provide to Patients

• finasteride is associated with low mood, depression, suicidal thoughts and sexual dysfunction (decreased sex drive, erectile dysfunction and ejaculation disorders)
• before taking finasteride, read and keep the Finasteride patient cards and patient information leaflet within your pack and inform your doctor if you have any personal history of depression or suicidal thoughts
• if you have seriously harmed yourself or feel you are at risk of serious harm, contact emergency services on 999 immediately
• stop finasteride 1mg immediately if you develop depression or suicidal thoughts and contact your doctor as soon as possible
• if you are prescribed finasteride 5mg or dutasteride and you develop depression or suicidal thoughts, contact your doctor as soon as possible
• if prescribed finasteride or dutasteride and you experience decreased sex drive, difficulty having an erection or ejaculation problems you should contact your doctor for medical advice

For further details, please view the full Drug Safety Update here.