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Finasteride – risk of psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)

Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

A pharmacovigilance case-noncase study of 3282 users of finasteride used VigiBase, the World Health Organization’s global database of individual case safety reports, and found a disproportional signal of suicidality, depression, and anxiety associated with finasteride use for alopecia in patients younger than 45 years (1)

  • no such signal was associated with drugs that had different mechanisms of action but similar indications or with drugs that had similar mechanisms and adverse effect profiles
  • study authors concluded that findings suggest that the risk of suicidality, depression, and anxiety should be considered when prescribing finasteride to younger patients with alopecia who may be more vulnerable to the drug’s adverse effects

UK reports of persistent sexual dysfunction after discontinuation of finasteride (2)

  • since the first report was received in November 1992, the MHRA has received 426 Yellow Card reports up until 5 April 2024 of finasteride (both 1mg and 5mg formulations) and sexual dysfunction, including reports of erectile dysfunction (inability to get and maintain an erection) and decreased sex drive
  • in almost half of these reports, the outcome was recorded as ‘not recovered’ or ‘not resolved’.

UK reports of psychiatric dysfunction with finasteride (2)

  • since the first report was received in February 1993, the MHRA has received 281 reports of finasteride and depressed mood disorders and suicidal and self-injurious behaviours, up until 5 April 2024

Advice for healthcare professionals (2):

  • finasteride has been associated with depression, suicidal thoughts and sexual dysfunction
  • patients have reported that sexual dysfunction (including decreased libido and erectile dysfunction) has persisted even after treatment was stopped
  • before prescribing finasteride, ask patients if they have a history of depression or suicidal ideation
  • advise patients to stop finasteride 1mg (Propecia) for male pattern hair loss immediately if they develop depression or suicidal thoughts and to contact their doctor as soon as possible
  • advise patients prescribed finasteride 5mg (Proscar) for benign prostatic hyperplasia to consult their doctor for further medical advice as soon as possible if they develop depression or suicidal thoughts
  • monitor patients for psychiatric and sexual side effects
  • a patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers
  • report suspected adverse drug reactions associated with finasteride via the Yellow Card scheme

Reference:

  1. Nguyen DD, Marchese M, Cone EB, Paciotti M, Basaria S, Bhojani N, Trinh QD. Investigation of Suicidality and Psychological Adverse Events in Patients Treated With Finasteride. JAMA Dermatol. 2021 Jan 1;157(1):35-42
  2. Drug Safety Update volume 17, issue 9: April 2024: 1

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