Pharmacovigilance Analysis of Vinorelbine: Cardiopulmonary and Pediatric Safety Profiles Based on FAERS and VigiBase Data

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 (BCPNN) to identify potential safety signals. Among 1,712 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 blood and lymphatic system disorders but also with respiratory, thoracic and mediastinal disorders, and cardiac disorders, indicating notable cardiopulmonary safety concerns. Most AEs occurred within 30 days after administration. In pediatric patients, vinorelbine showed a significant association with endocrine disorders. These findings underscore the need for enhanced monitoring of cardiopulmonary effects during vinorelbine treatment, particularly during combination therapy, and heightened vigilance for endocrine-related AEs in pediatric patients.