Finasteride-associated suicidality: a pharmacovigilance analysis of FAERS database

Abstract

The adverse events of finasteride remained controversial since the introduction of the drug. However, after 2012, suicidality was reported to a greater extent. So, we investigated the association of suicidality and finasteride using FAERS database. We conducted a disproportionality analysis to identify signals of suicidality with finasteride using reporting odds ratio. Then, we obtained significant signals against whole database (ROR, 6.25; 95% CI, 5.85–6.67) and against drug of similar indication (minoxidil) (ROR, 55.1; 95% CI, 42.8–70.8). In sensitivity analyses, older patients showed significant signals for suicidal ideation (ROR, 16.5; 95% CI, 4.85-56.3) and for both before 2012 (ROR, 3.88; 95% CI, 1.04-14.41) and after 2012 (ROR, 4.04; 95% CI, 2.28-7.14). Hence, analyses confirmed that older patients have higher risk of suicidality compared to younger patients. Also, stimulated reporting did not cause suicidality to give signals for finasteride. However, there are certain limitations which needs further research attention.