Real-world safety profile of trazodone: Evidence from FAERS pharmacovigilance data (2004-2024).

Abstract

ObjectiveTrazodone has shown good efficacy in patients with major depressive disorder accompanied by insomnia and anxiety symptoms. However, real-world data on its long-term adverse effects remain limited. This study analyzes a large dataset to assess the relationship between trazodone and specific adverse events (AEs).MethodsData from the FAERS database covering the period from the first quarter of 2004 to the third quarter of 2024 were collected, standardized, and analyzed. Signal detection was performed using the ROR, PRR, BCPNN, and MGPS algorithms.ResultA total of 5172 reports were collected, covering 27 system organ classes and 1616 preferred terms (PTs). Contrary to the official drug label, reproductive system and breast disorders exhibited the highest correlation, with involved PTs including priapism, clitoral engorgement, and penile vein thrombosis. Surprisingly, trazodone showed the highest signal strength in association with penile amputation. The detection of wandering pacemaker and electrocardiogram PR prolongation emphasized the cardiovascular event risk. Notably, completed suicide and serotonin syndrome exhibited relatively high occurrence rates. Other uncommon but significant AEs, such as wound infection fungal, hypervigilance, and hangover, were also detected. Additionally, new and clinically significant rare AEs, such as hyper IgE syndrome and acute myopia, were identified.ConclusionsThis study provides valuable data on the AEs of trazodone, particularly its potential reproductive system adverse effects, cardiovascular risks, and other rare events. Our findings lay the foundation for further safety assessments of trazodone.