BMC pharmacology & toxicology
Multinational pharmacovigilance assessment of drug-associated esophageal ulceration and perforation: evidence from FAERS, JADER, and Canada Vigilance
By Zhang L, Luan X, Liu C and 4 others.
Abstract
Background
Drug-associated esophageal ulceration and perforation are uncommon but clinically serious adverse events. This study characterized post-marketing reporting patterns for these events across three spontaneous reporting systems.
Methods
Reports from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report database (JADER), and Canada Vigilance from 2004 to 2025 were analyzed using predefined Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. Disproportionality was assessed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). In FAERS, least absolute shrinkage and selection operator (LASSO) regression followed by multivariable logistic regression was used for exploratory signal prioritization. Reported time-to-onset was summarized for drug-report records with valid therapy start and event onset dates.
