| [Puppose] Irinotecan, a topoisomerase I inhibitor, is widely used in the treatment of digestive cancers. However, comprehensive large-scale real-world safety data remain limited. This study aimed to analysis irinotecan-related adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) to identify potential safety signals. [Methods] A retrospective pharmacovigilance analysis was conducted using FAERS database from Q1 2004 to Q4 2024. After duplicate removal, four disproportionality analysis methods were applied: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM). [Results] A total of 8,456 irinotecan-related reports comprising 27,177 AEs were identified. The most frequently reported AEs included diarrhea, nausea, neutropenia, vomiting, and fatigue. Additionally, several unexpected and significant AE signals were detected, such as cell-mediated cytotoxicity, pyomyositis, neuropathic muscular atrophy, administration site recall reaction and ischemic neuropathy. The median time to AE onset was 31 days, with most occurring within the first month of treatment. [Conclusions] This study reveals both established and newly identified adverse event signals for irinotecan, underscoring the need for ongoing pharmacovigilance. While these findings enhance our understanding of irinotecan’s real-world safety profile in digestive cancers over the past two decades, further large-scale prospective research is necessary for confirmation. |
