A systematic safety assessment of zuranolone: real-world adverse event analysis from the FAERS database.

OBJECTIVE

This 2023study aims to evaluate the adverse reaction profile of Zuranolone through large-scale analysis of real-world data and to explore its underlying mechanisms, thereby providing complementary evidence for the safe clinical use of Zuranolone.

METHODS

Reports associated with Zuranolone were extracted from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering the period from the third quarter (Q3) of 2023 to the first quarter (Q1) of 2025. Signal detection was performed using four distinct methods: the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian Confidence Propagation Neural Network (BCPNN), and the Empirical Bayesian Geometric Mean (EBGM).

RESULTS

A total of 464 reports of adverse events (AEs) related to Zuranolone were included in this study. Signal detection analysis revealed that Zuranolone was most significantly associated with AEs in the System Organ Classes (SOCs) of nervous system disorders and psychiatric disorders. Among the frequently reported AEs, those related to central nervous system (CNS) depression were particularly prominent, including somnolence (135 cases), dizziness (101 cases), sedation (35 cases), and tremor (32 cases). The study also identified common psychiatric AEs, including known events such as anxiety, suicidal ideation, depression, insomnia, depressed mood, and perinatal depression, as well as new potential AEs including panic attack, anger, bradyphrenia, intrusive thoughts, tachyphrenia, and decreased interest.

CONCLUSION

Enhanced monitoring for AEs related to nervous system disorders and psychiatric disorders is required during the clinical use of Zuranolone.