A disproportionality analysis of dual bronchodilators based on the FAERS

Abstract Objective To detect adverse event (AE) signals for dual bronchodilators using the Food and Drug Administration(FDA) Adverse Event Reporting System (FAERS), assess their potential safety risks, and inform pharmacovigilance. Methods AE reports pertaining to dual bronchodilators were retrieved from the FAERS for the period covering the fourth quarter of 2013 through the fourth quarter of 2025. Signal detection was subsequently conducted using both the Reporting Odds Ratio (ROR) and the Multi‑Item Gamma Poisson Shrinker (MGPS) method. Results From the FAERS database, the numbers of AE reports with umeclidinium/vilanterol, indacaterol/glycopyrronium, tiotropium/olodaterol, glycopyrronium/formoterol, and aclidinium/formoterol as primary suspected drugs were 1,674, 674, 572, 102, and 52, respectively; the corresponding numbers of detected AE signals were 140, 111, 64, 30, and 10; and the numbers of involved system organ classes (SOCs) were 19, 16, 15, 12, and 7, respectively. Conclusion The AEs of dual bronchodilators were predominantly observed in the SOCs of respiratory, thoracic and mediastinal disorders, cardiac disorders, and infections and infestations, etc. The distribution of AE signals and serious adverse events(SAEs) varied across the five drugs. Accordingly, individualized drug selection is advised in clinical practice, with special attention to early risk monitoring in elderly patients and those with compromised baseline cardiopulmonary function.