Safety analysis of vinorelbine in the real world: a pharmacovigilance study based on the FAERS database

Vinorelbine is widely used for non-small cell lung cancer, breast cancer, and other solid tumors, yet real-world safety data remain limited. We analyzed adverse events associated with vinorelbine using the FDA Adverse Event Reporting System from Q1 2004 to Q1 2025. Reports mentioning vinorelbine were retrieved and deduplicated, and disproportionality analyses (ROR, PRR, BCPNN, EBGM) were performed, with subgroup analyses by age, sex, and severity. A total of 2,321 reports involving 8,956 events were identified. The most frequent events were neutropenia, pyrexia, nausea, vomiting, dyspnea, febrile neutropenia, and diarrhea. Elderly patients had higher risks of interstitial lung disease and respiratory failure, while females showed more neutropenia. The median onset time was 20 days, with most events occurring in the first treatment month. These findings highlight important safety signals of vinorelbine and underscore the need for close monitoring, particularly early in treatment and among older adults.