Pharmacovigilance assessment of vinorelbine-associated adverse events using FAERS and VigiBase

Vinorelbine is a widely used vinca alkaloid chemotherapeutic agent. Although its hematologic and gastrointestinal toxicities are well characterized, its cardiopulmonary safety profile remains insufficiently defined, and evidence in pediatric populations is limited. This study aimed to systematically evaluate vinorelbine-associated adverse events (AEs) using the FDA Adverse Event Reporting System (FAERS) and WHO VigiBase databases, with particular focus on cardiopulmonary events and pediatric safety. AEs from FAERS (2004 Q1–2024 Q4) and VigiBase (up to 2024 Q4) were analyzed using disproportionality methods, including reporting odds ratio (ROR) and Bayesian confidence propagation neural network to identify potential safety signals. Among 1712 FAERS and 16,175 VigiBase reports listing vinorelbine as the primary suspected drug, 210 significant signals were detected across multiple system organ classes. Strong associations were found not only with hematologic toxicities but also with respiratory, thoracic, and cardiac disorders (notable cardiopulmonary signals), with most AEs occurring within 30 days of administration. In pediatric patients, vinorelbine showed a significant association with endocrine disorders. These findings highlight the importance of enhanced monitoring of cardiopulmonary effects during vinorelbine treatment, particularly during combination therapy, and heightened vigilance for endocrine-related AEs in pediatric patients. As a retrospective observational study based on spontaneous reporting databases, underreporting and unmeasured confounders may affect the interpretation of results.