Adverse events related to buspirone: a real-world pharmacovigilance study using the FAERS database

Clinical Snapshot

Key Findings

• P Value: Not reported in abstract

• Effect Size: Most common AEs: dizziness (n=141), anxiety (n=133), drug interaction (n=86), serotonin syndrome (n=83), tremor (n=71)

• Primary Outcome: Adverse event signals associated with buspirone use

• Nnt Or Sensitivity: Median time to onset: 10 days (IQR: 16 days)

• Confidence Interval: Not reported in abstract

Clinical Application

Findings readily applicable to clinical practice for safety monitoring and patient counselling Buspirone is PBS-listed in Australia; findings relevant for TGA pharmacovigilance and RACGP prescribing guidelines for anxiety management Patients prescribed buspirone for anxiety disorders in routine clinical practice

Abstract

Buspirone, a widely used anxiolytic, has incompletely characterized adverse effects. This study aimed to comprehensively characterize buspirone's safety profile by a large-scale analysis of real-world data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database, covering Q1 2006 to Q1 2025. We collected 1744 buspirone-related adverse event reports and analyzed them utilizing various signal detection techniques, including proportional reporting ratio (PRR), reporting odds ratio (ROR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). The most common adverse events were categorized into nervous system disorders and psychiatric disorders, with "dizziness" (n = 141), "anxiety" (n = 133), "drug interaction" (n = 86), "serotonin syndrome" (n = 83), and "tremor" (n = 71) being the most frequently reported. Notably, several safety issues linked to suicide exhibited considerable signals. In addition to the adverse events already listed on the package insert, our research identified unanticipated adverse events associated with improper buspirone use, including "drug abuse" (n = 43), "intentional overdose" (n = 30), and "drug level increased" (n = 17). These findings indicated a potential risk of abuse with buspirone exposure during therapeutic use. Moreover, the study detected a relatively rare but noteworthy signal associated with abnormal body weight, such as "obesity" (n = 19), which merits further attention. The median time to onset for adverse events was 10 days (IQR:16). In conclusion, this pharmacovigilance research underscored the safety hazards related to prolonged buspirone usage, confirmed known risks and identified novel safety signals. These findings enriched the awareness of buspirone's safety profile and provided evidence-based guidance in clinical settings.

References

1. 1.Wen, Z., Liu, X., Guo, P., Wang, C., Xu, X., & Liu, P. (2026). Adverse events related to buspirone: a real-world pharmacovigilance study using the FAERS database. Journal of Affective Disorders, 121240. https://doi.org/10.1016/j.jad.2026.121240