Drug-induced gastric motility disorders: A disproportionality analysis from the FAERS and CVARD databases

by Zhiheng Qian, Ni Jiang Background Delayed gastric emptying and gastroesophageal reflux represent critical yet frequently underrecognized complications in hospitalized patients, particularly in the context of polypharmacy. While multiple medication classes have been implicated in disrupting gastrointestinal motility, the comprehensive risk spectrum of individual drugs remains poorly characterized.

This study aimed to conduct a comprehensive disproportionality analysis to identify drugs associated with delayed gastric emptying and reflux using large-scale pharmacovigilance data. Methods We analyzed adverse event reports from the FDA Adverse Event Reporting System (FAERS; 2004–2025; n > 58 million) and validated findings against the Canada Vigilance Adverse Reaction Online Database (CVARD).

Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN). Weibull time-to-onset analysis was conducted to characterize temporal patterns of adverse event onset.

Results Among the top 50 drugs screened, 20 demonstrated positive signals across all three algorithms.