Real-world adverse event patterns of ramucirumab in the FAERS database (2014-2024): a comprehensive pharmacovigilance study.

Ramucirumab, a VEGFR-2-targeting monoclonal antibody, has been widely adopted in the treatment of various solid tumors. However, its safety profile in routine clinical practice remains incompletely understood. To address this, we examined adverse event reports associated with ramucirumab collected in the FAERS database between 2014 and 2024. Following careful deduplication, 3,435 reports were analyzed, identifying 139 Preferred Terms with significant signals across four disproportionality methods. In addition to well-established toxicities such as gastrointestinal perforation, hemorrhage, hypertension, and proteinuria, several previously underrecognized events were detected, including heart failure, chylothorax, and pseudocirrhosis. Gastrointestinal perforation events were particularly frequent and often occurred within the first three months of therapy. Temporal analyses indicated that the early treatment period is critical for the onset of severe adverse events. While the FAERS data cannot confirm causality, these findings underscore the importance of vigilant monitoring, especially during the initial phase of treatment, and highlight areas for further clinical and mechanistic investigation into the safety risks of ramucirumab.