Risk factors for drug-related gastrointestinal ulcer:a retrospective pharmacovigilance study

TL;DR

This study identifies medications most strongly linked to gastrointestinal ulcers using FDA data, highlighting drugs like Sevelamer and acetylsalicylic acid as significant risk factors.

Contribution

The study provides novel insights into drug-related gastrointestinal ulcer risk factors using a comprehensive pharmacovigilance analysis of FAERS data.

Findings

Nonsteroidal anti-inflammatory drugs, Sevelamer, and immunosuppressants are strongly associated with gastrointestinal ulcers.

Multivariate analysis identified Sevelamer and acetylsalicylic acid as having the highest incidence of ulcer cases.

The study highlights the need for prospective validation of drug-ulcer associations.

Abstract

Despite the fact that many medications have been linked to gastrointestinal ulcers, the extent to which most of these drugs contribute to such ulcers is not well understood. This study investigates the risk factors linked to gastrointestinal ulcers caused by drugs by analyzing large datasets obtained from the FDA Adverse Event Reporting System (FAERS).

The data from the first quarter of 2015 to the third quarter of 2025 were analyzed using the report odds ratio (ROR), combined with single-factor, LASSO, and multivariate regression analysis methods, to thoroughly investigate the risk factors associated with drug-related gastrointestinal ulcers.

A total of 983 medications linked to adverse events concerning gastrointestinal ulcers were identified in this study, which included 21,191 patients. The medications most frequently linked to gastrointestinal ulcers include nonsteroidal anti-inflammatory drugs, anticoagulants, antiplatelet agents, and immunosuppressants. In the multifactorial logistic regression analysis, Sevelamer and acetylsalicylic acid emerged as the two medications most strongly associated with the highest incidence of gastrointestinal ulcer cases.

Nonsteroidal anti-inflammatory drugs, Sevelamer, immunosuppressants, and other medications have shown a significant positive association with gastrointestinal ulcers. These findings provide hypothetical clues for pharmacovigilance; however, establishing a causal relationship requires further validation through prospective studies in populations.

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