Analysis of Esophageal Ulcers Using the Japanese Adverse Drug Event Report Database.

Goals: Identifying oral and parenteral drugs associated with esophageal ulcers is important. A comprehensive analysis of a spontaneous adverse event reporting database can support early detection and prevention of drug-induced esophageal ulcers.

Background: Drug-induced esophageal ulcers are primarily associated with orally administered drugs. However, recent studies have suggested potential association with parenterally administered drugs. These parenteral cases have not been comprehensively analyzed in previous research.

Study: We conducted disproportionality analysis using data from the Japanese Adverse Drug Event Report (JADER) database between April 2004 and December 2023. Signals for esophageal ulcers were detected using the reporting odds ratio with a 95% confidence interval. Weibull distribution analysis was performed to determine the time to adverse event onset for drugs showing signals of esophageal ulcers. Orally and parenterally administered drugs were analyzed separately.

Results: Signals were detected for 15 orally administered drugs and 7 parenterally administered anticancer drugs. Weibull distribution analysis revealed that doxycycline and dabigatran etexilate induced the early onset of pill-induced esophagitis, with median onset times of 8 and 12.5 days. Meanwhile, bevacizumab and paclitaxel showed consistent occurrence patterns of esophageal ulcers throughout the treatment period.

Conclusions: Our comprehensive analysis of the JADER database identified signals for esophageal ulcers associated with both oral and parenteral drugs, along with their characteristic onset patterns. These findings highlight the clinical importance of considering the potential for esophageal ulcers with specific oral and parenteral drugs and suggest that early intervention may be crucial in mitigating their occurrence.