Suicidality Risks Associated with Finasteride, a 5-Alpha Reductase Inhibitor: An Evaluation of Real-World Data from the FDA Adverse Event Reports

Abstract

Background: Finasteride, a 5α-reductase inhibitor, is used for androgenetic alopecia and benign prostatic hyperplasia. However, concerns have emerged about its psychiatric side effects, including suicidality. This study analyzed finasteride-related reports from the FDA Adverse Event Reporting System (FAERS) to identify potential safety signals. Methods: Adverse events reported from 2015 to 2024 were extracted using preferred terms, quantified using Bayesian analysis and disproportionality metrics, including empirical Bayesian geometric mean (EBGM), information component (IC), reporting odds ratio (ROR), and proportional reporting ratio (PRR). Results: Most were male (87%), with 43% aged 18-40 years, primarily using finasteride for hair loss. Disproportionality metrics for suicidality-related events fluctuated between 2019 and 2024. In 2019, the ROR was 27.51 (95% CI: 23.22-32.58), the PRR was 21.96 (95% CI: 18.54-26.01), the EBGM was 20.50, and the IC was 4.36. A slight decline was observed in 2020, a surge in 2021, and a peak in 2022 (ROR 34.64 (95% CI: 28.36-41.88), PRR 27.82 (95% CI: 22.30-34.61), EBGM 24.96, IC 4.64). Although a sharp rise in suicidality reports was noted in 2024, the rates of ROR and PRR dropped to 19.04 (95% CI: 17.02-21.30) and 16.53 (95% CI: 14.78-18.50), respectively. Serious outcomes such as disability (18.7%), life-threatening events (12.9%), and death (7.5%) were also noted. Conclusions: The upward trend in suicidality-related safety signals among young male users since 2019, which peaked in 2024, reflects emerging safety concerns among finasteride users, reinforcing the need for pharmacovigilance. Collaborative action among healthcare professionals, regulatory authorities, and pharmaceutical companies, along with clear warnings and mental health assessments before and throughout finasteride therapy, can mitigate potential psychiatric risks and enhance patient safety.

Keywords: finasteride; neurosteroids; pharmacovigilance; psychiatric adverse effects; suicidality.

Figure 1

The trend of finasteride-related suicidality adverse event reports with corresponding empirical Bayes geometric mean (total reports/year and EBGM/year).

Figure 2

Finasteride-related suicidality adverse event reports stratified by age (years).

Figure 3

Finasteride-related suicidality adverse event reports stratified by the reporter’s occupation.

Figure 4

Finasteride-related suicidality adverse event reports stratified by the country of the reporter.

Figure 5

Outcomes of the finasteride-related suicidality adverse event reports (ADEs).

Figure 6

Finasteride-related suicidality adverse event reports stratified by indication.