Comprehensive analysis of cefuroxime-associated adverse events: Insights from JADER database (2004-2024) and comparison with FAERS database

Abstract

Cefuroxime, as a second-generation cephalosporin, is widely used in clinical practice. In recent years, research using the Food and Drug Administration Adverse Event Reporting System (FAERS) database has led to new discoveries about the adverse event profile of cefuroxime. However, there is currently a lack of systematic research on the safety of cefuroxime based on the Japan Adverse Drug Event Report (JADER) database. This study analyzed the clinical characteristics and adverse event signals associated with cefuroxime using the JADER database and further compared the findings with those from the FAERS database. A descriptive analysis was conducted on the clinical characteristics of adverse event reports associated with cefuroxime, including report year, report season, onset time, reporter type, sex, age, weight, dose, frequency, and indication. Four disproportionality algorithms were employed to identify adverse event signals. Subsequently, the clinical characteristics and disproportionality signals of cefuroxime in the JADER database were contrasted with those in the FAERS database. A total of 60 adverse event reports and 132 adverse events related to cefuroxime were identified from the JADER database. "Oculomucocutaneous syndrome" emerged as a newly identified disproportionality signal in the JADER database, which was neither reported in the FAERS database nor previously documented in cefuroxime's labeling. "Anaphylactic shock," "drug-induced liver injury," "jaundice," and "Stevens-Johnson syndrome" were identified as disproportionality signals in both the JADER and FAERS databases. "Anaphylactic shock" had a stronger signal in the FAERS database, and "drug-induced liver injury" and "jaundice" exhibited stronger signals in the JADER database. This study provides a descriptive analysis and signal detection using the JADER database, contributing to previous research based solely on the FAERS database and offering an additional perspective on the clinical safety profile of cefuroxime. This finding suggests a potential need for enhanced monitoring for "skin and subcutaneous tissue disorders," "immune system disorders," and "hepatobiliary disorders." It should be noted that the results from the JADER and FAERS databases may be influenced by reporting biases. Therefore, further studies are warranted to corroborate the findings.

Keywords: FAERS; JADER; cefuroxime; hepatobiliary disorders; immune system disorders; skin and subcutaneous tissue disorders.