Pharmacovigilance analysis of the FGFR inhibitor futibatinib using the FDA adverse event reporting system (FAERS) database

Background Futibatinib, a novel FGFR inhibitor, is a promising therapy for cancers with FGFR alterations. However, its safety profile remains under investigation. This study evaluates futibatinib-associated adverse events using the FDA Adverse Event Reporting System (FAERS). Methods A retrospective pharmacovigilance analysis was conducted using FAERS data from January 1, 2013, to March 9, 2025. Disproportionality analysis was performed via OpenVigil 2.1, with signals defined by a reporting odds ratio (ROR) > 2.00 and a 95% confidence interval lower bound >1.00. Events with at least two reports were included after deduplication and standardization. Results Strong safety signals were identified. Hyperphosphatasemia showed the highest association (ROR 1612.73; 6 events), followed by elevated blood phosphorus (ROR 603.85; 3 events). Dermatologic toxicities, including onycholysis (ROR 520.15) and onychoclasis (ROR 126.20), were also notable. Conclusion These findings highlight the range of adverse events associated with this agent. These events may reflect direct drug effects and individual variability. Further studies are needed to clarify mechanisms and inform clinical management.