Analysis of infection-related adverse events induced by proton pump inhibitors based on the FAERS and JADER databases

This study aims to analyze infection-related adverse events related to different proton pump inhibitors (PPIs) and explore the characteristics of Infection-related adverse events and the intensity of drug association based on the U.S. Food and Drug Administration adverse event reporting system (FAERS) database and Japan Adverse Drug Event Report Database (JADER), so as to promote the rational application of PPIs.

The adverse event reports of omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, dexlansoprazole and vonoprazan in 78 quarters from the first quarter of 2004 to the fourth quarter of 2023 were searched and extracted by FAERS and JADER, and the adverse events were systematically classified by the Medical Dictionary for Regulatory Activities term set. Then, data processing and analysis of the 7 drug-related reports were carried out by reporting odds ratio method.

Inclusion of infection-related adverse event report statistics: in the FAERS database, 2 806 reports of omeprazole, 1 652 reports of lansoprazole, 2 922 reports of pantoprazole, 265 reports of rabeprazole, 6 004 reports of esomeprazole, and 297 reports of dexlansoprazole; and in the JADER database, 79 reports of omeprazole, 137 reports of esomeprazole, 414 reports of lansoprazole, 117 reports of rabeprazole, and 204 reports of vonoprazan; 3 185 adverse drug reactions (ADRs) signals were obtained in the FAERS database with signals involving 27 system organ class, whereas 478 ADRs signals were obtained in the JADER database with ADRs signals involving 25 system organ class, and infectious pneumonias were the most common in both databases.

In the use of PPIs, we should pay attention to the occurrence of related adverse reactions, especially the damage to the infection-related adverse effects, monitor the relevant indicators, and take timely intervention measures to ensure the safety of medication.