Following serious spontaneous cases reported over time at [the] national level with finasteride 1 mg…ANSM has long been very concerned by the safety profile of finasteride 1 mg, especially regarding psychiatric disorders and sexual dysfunction which can persists after discontinuation of treatment. Despite [our pharmacovigilance] measures, cases of psychiatric disorders (including suicidal ideation) and sexual dysfunction (including long lasting sexual dysfunction that could lead to mood disorders) are still reported. Even though a causal association between finasteride and suicidal ideation has not been established, it was considered at least a reasonable possibility, given that known ADRs such as sexual disorders, including erectile dysfunction/impotence, depression, decreased libido, may lead to suicidal ideation.
—Notification to the European Medicines Agency: September 13, 2024