Multidimensional Assessment of Adverse Events of Finasteride: A Real-World Pharmacovigilance Analysis Based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024

This study analyzed 11,557 adverse event reports related to finasteride from the FDA Adverse Event Reporting System (FAERS) between 2004 and 2024. The majority of affected patients were male (86.04%), primarily young adults aged 18-45 years (27.22%). The study identified 73 adverse events (AEs) across 7 system organ categories, including common issues like erectile dysfunction and sexual dysfunction, as well as less common ones like Peyronie’s disease and post 5α reductase inhibitor syndrome. Depression and anxiety were notable AEs for both genders. The median onset time for AEs was 61 days, with many occurring within the first month of treatment and some persisting beyond a year. The findings highlight both known and novel AEs, with variations based on gender and age, providing valuable insights for the safe use of finasteride in clinical practice.