Abstract
BACKGROUND: Oral finasteride 1 mg/day is indicated for androgenetic alopecia (AGA), while 5 mg/day is for benign prostatic hyperplasia (BPH). Oral finasteride has been linked with depression and suicide; however, a causal association is uncertain. The so-called post-finasteride syndrome (PFS) refers to a "cluster" of side effects experienced by some men (i.e., cis men) after taking oral finasteride. AIMS: The objective of the current study was to evaluate the association of depression and suicide with oral finasteride in males, using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). As a secondary objective, we conducted disproportionality analyses of FAERS data to assess whether oral dutasteride use was linked to psychological symptoms related to depression and suicidality. METHODS: We conducted disproportionality analyses for 5 AEs using MedDRA terms. Associations were metricized with the reporting odds ratio (ROR) across 3 time periods, namely, 2006-2011, 2013-2018, and 2019-2023. RESULTS: No significant AEs/signals were detected with oral finasteride from 2006 to 2011 for any of the 5 AEs (completed suicide, depression suicidal, suicidal behavior, suicidal ideation, attempted suicide). Signals were detected for some AEs during 2013-2018 and 2019-2023. For example, there was a greater likelihood of reporting suicidal ideations in individuals taking oral finasteride during 2013-2018 (ROR = 2.8, p < 0.05) and 2019-2023 (ROR = 5.0, p < 0.05). In contrast, no signals were detected with oral dutasteride during 2006-2011, 2013-2018, and 2019-2023. CONCLUSION: The study found no significant correlation between oral finasteride and depression/suicide reports from 2006 to 2011 but noted a significant number of such reports in 2013-2018 and 2019-2023. This increase may be linked to heightened awareness of AEs following the recognition of so-called PFS in 2012.