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

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
• the 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 and dutasteride (3)

• since 1994 to 31 May 2025 includes 170 reports of suicidal ideation and related terms for finasteride (1mg and 5mg) and 5 reports for dutasteride 0.5mg
  • there were 19 fatal reports of suicide for finasteride and no fatal reports of suicide for dutasteride

Advice for healthcare professionals (2):

• 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

Following a review of the available data, the European Pharmacovigilance Risk Assessment Committee (PRAC) has confirmed suicidal ideation as a side effect of finasteride tablets, with an unknown frequency (4)

• most cases were reported in association with the 1mg tablets, used to treat androgenetic alopecia
• frequency of the side effect is unknown, meaning that it is not possible to estimate it from available data
• the product information for finasteride 1 mg tablets will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes
• a patient card will be included in the packages of 1 mg finasteride tablets to remind patients of these risks and to advise them about the appropriate course of action.

References:

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. MRHA Drug Safety Update volume 17, issue 9: April 2024: 1.
3. MHRA Drug Safety Update volume 19, issue 10: May 2026: 1.
4. European Medicines Agency (EMA) (May 8th 2025). Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines.