Comparative Real‐World Safety Profiles of Fibroblast Growth Factor Receptor Inhibitors: A Pharmacovigilance Study
Seda Jeral Evinç, Çağla Eyüpler Akmercan, Zeliha Birsin, Selin Cebeci, Emir Çerme, Vali Aliyev, Hamza Abbasov, Ebru Çiçek, Süheyla Atak, Nebi Serkan Demirci, Çiğdem Papila, Özkan AlanABSTRACT
Objectives
This study aimed to compare the real‐world safety profiles of approved fibroblast growth factor receptor (FGFR) inhibitors and to identify drug‐specific adverse event patterns using data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods
A retrospective pharmacovigilance analysis was conducted using FAERS reports submitted between January 1, 2014, and October 31, 2025. Adverse event reports involving erdafitinib, pemigatinib, futibatinib, and infigratinib were included when an FGFR inhibitor was listed as the primary suspect drug. Adverse events were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) version 28.0 and categorized by System Organ Class. Disproportionality analyses were performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs).
Results
A total of 2081 FGFR inhibitor‐related adverse event reports were identified. Erdafitinib accounted for the largest proportion of reports (53.8%), followed by pemigatinib (34.8%), futibatinib (8.2%), and infigratinib (3.2%). Overall, 69.8% of reported events were classified as serious. Infigratinib showed a markedly increased reporting likelihood for blurred vision (ROR 8.92; 95% CI: 3.73–21.36) and oral mucosal toxicity (ROR 3.38; 95% CI: 1.80–6.34). Hyperphosphatemia was most strongly associated with futibatinib (ROR 3.11; 95% CI: 1.93–5.01), whereas erdafitinib demonstrated a reduced reporting likelihood for this event (ROR 0.43; 95% CI: 0.29–0.63). Ocular adverse events, including dry eye, exhibited variable reporting patterns across agents.
Conclusion
FGFR inhibitors demonstrated differences in adverse event reporting patterns rather than a uniform class effect, although pharmacovigilance data do not allow estimation of true incidence, risk, or causal relationships.