Risk factors for drug-related impaired gastric emptying: a pharmacovigilance analysis of the FDA adverse event reporting system

Background: Pulmonary aspiration remains a major perioperative patient safety issue. Drug-related impaired gastric emptying (IGE) is a recognized yet underappreciated risk factor for aspiration. With the increasing use of medications such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), concerns have grown regarding their potential to delay gastric emptying and thereby elevate aspiration risk. However, real-world data on drug-related IGE remain limited. Objective: To identify risk factors for drug-related IGE using real-world pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS). Methods: A retrospective pharmacovigilance study was conducted using FAERS data from Q1 2004 through Q2 2025. Disproportionality analysis, logistic regression, LASSO regression and time-to-onset analysis were performed to investigate the association between drugs and IGE from different perspectives. Results: A total of 731 drugs related to IGE. Six of the top 10 most frequently reported drugs associated with IGE were antidiabetic agents, including five GLP-1RAs: semaglutide, dulaglutide, tirzepatide, exenatide, and liraglutide. Multi-factor analysis identified female sex, age <63 years, and exposure to any of nine specific drugs-including GLP-1RAs, insulin lispro, sodium oxybate, olmesartan, and esomeprazole-as independent risk factors for drug-related IGE. The model achieved an ROC-AUC of 0.739, indicating good discriminatory capability. Time-to-onset analysis revealed an early-failure pattern for all nine drugs. Conclusion: Our study shows that female sex, younger age, and use of specific medications are associated with an increased risk of drug-related IGE. These findings may provide valuable evidence to support the early recognition of drug-related IGE and for optimizing anaesthetic plans and perioperative personalized fasting strategies.