Gastrointestinal adverse events associated with axitinib: pharmacovigilance analysis of the Japanese adverse drug event report database.

backgroundAxitinib is widely used to treat metastatic renal cell carcinoma; however, the characteristics of its gastrointestinal adverse events (AEs) remain poorly understood. This study evaluated gastrointestinal AEs associated with axitinib using the Japanese Adverse Drug Event Report database.

methodsReports submitted between April 2004 and December 2024 were analyzed. Gastrointestinal AE reports were extracted, and disproportionality was evaluated by calculating reporting odds ratios (RORs).

resultsAmong 3,221,393 reports analyzed, 5,609 involved axitinib, including 800 gastrointestinal AEs. Signals were detected for 20 gastrointestinal AEs. Fatal outcomes were reported for four events, with gastrointestinal perforation and intestinal perforation showing the highest proportions of reported fatal outcomes. Median time to onset ranged from 44 to 148 days. Weibull distribution analysis was performed for AEs with sufficient reports. Diarrhoea showed an early failure pattern, whereas nausea exhibited a wear-out failure pattern with an increasing reporting hazard over time. Decreased appetite, gastrointestinal perforation, pneumatosis intestinalis, and rectal haemorrhage demonstrated a random failure pattern, occurring throughout the treatment period.

conclusionsThis post-marketing analysis identified gastrointestinal AEs associated with axitinib, including several serious events with fatal outcomes. These AEs may occur both early and later during treatment, underscoring the need for continuous monitoring to facilitate prompt detection and management of severe gastrointestinal complications.