Real-world pharmacovigilance of risperidone: Analysis based on FAERS reports from physicians and pharmacists.

ABSTRACT:

Objective

Risperidone, a second-generation antipsychotic widely used in clinical practice, has not been systematically evaluated for its long-term real-world adverse events. This study analyzed risperidone-related AEs reported in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) over nearly two decades, providing a reference for clinical medication.

Methods

Data on risperidone was collected from FAERS covering the period from the first quarter of 2004 to the third quarter of 2024. Signal detection was performed using the reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker algorithms.

Results

Among the 18,089 reports collected, a total of 27 system organ cla

SUBMITTER: Hao G 

PROVIDER: S-EPMC12533923 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature