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# Study Sees New Trazodone Adverse Events
- URL: https://www.fdaweb.com/study-sees-new-trazodone-adverse-events/
- Published: 2025-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:53:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158660

A pharmacovigilance study of the second-generation antidepressant trazodone based on reports in the FDA Adverse Event Reporting System (FAERS) between 2004 and 2024 identified several new adverse events. The [study](https://www.nature.com/articles/s41598-025-89632-7?ref=fdaweb.com), reported in the journal *Nature*, was conducted by researchers at a Chinese medical school and hospital.

The report says 179 significant adverse event signals were unearthed, with suicide, formulation toxicity, abnormal penile erection, insomnia, and cardiac and respiratory arrest reported with high frequency, “which was not entirely consistent with the specification record.”

“This study’s comprehensive pharmacovigilance analysis of the FAERS database adds evidence based on real-world data for the clinical safety management of trazodone,” the study concludes. “This study confirmed several known adverse events, such as insomnia, nightmares, and dry mouth, and identified several new potential adverse events, including suicide, drug abuse, priapism, and cardiac and respiratory arrest, etc. The multilevel analysis of this study provides a vigilant reference for clinicians to optimize drug selection and safety monitoring.”