Data mining and safety analysis of FGFR tyrosine kinase inhibitors based on the FAERS database.

ABSTRACT: Fibroblast growth factor receptor tyrosine kinase inhibitors (FGFR-TKIs), including erdafitinib, pemigatinib, and futibatinib, are a promising class of therapies for FGFR-driven cancers. While their efficacy is established in clinical trials, real-world safety data remain limited. This study leveraged post-marketing data from the FDA Adverse Event Reporting System (FAERS) between the second quarter of 2019 and the third quarter of 2024 to evaluate the safety profiles of FGFR-TKIs through disproportionality analysis. A total of 1,629 reports were included (erdafitinib: 982, pemigatinib: 558, futibatinib: 89). The most frequently reported adverse events (AEs) belonged to general disorders, gastrointestinal disorders, and skin and subcutaneous tissue disorders. Notably, several novel AEs not

SUBMITTER: Li P 

PROVIDER: S-EPMC12274456 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature