A Real-World Pharmacovigilance Study of Fruquintinib Based on the FDA Adverse Event Reporting System (FAERS) Database.

backgroundFruquintinib is a highly selective small-molecule inhibitor that targets vascular endothelial growth factor receptors and is approved for the treatment of metastatic colorectal cancer. Given its increasing clinical adoption, a comprehensive pharmacovigilance evaluation of the adverse events (AEs) is warranted.

methodsWe conducted an analysis of fruquintinib-related AEs by mining the FDA Adverse Event Reporting System (FAERS) database, covering the period from the fourth quarter of 2023 to the first quarter of 2025. The regulatory characterization of the AEs was based on the system organ class (SOC) and preferred term (PT) of the Medical Dictionary for Regulatory Activities (MedDRA). We employed four disproportionality analysis methods, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). Furthermore, Weibull distribution modeling was employed to characterize the temporal risk patterns of adverse reactions.

resultsAmong 1632 reports in which fruquintinib was flagged as the primary suspect drug, 78 PTs met the criteria of all four algorithms. In addition to known AEs listed on the drug label, the analysis also identified previously unrecognized AEs, encompassing large intestinal obstruction, dehydration, peripheral neuropathy, renal-limited thrombotic microangiopathy, and posterior reversible encephalopathy syndrome. The median onset time of fruquintinib-associated AEs was 18 days, with 66.16% of cases occurring within the first month of treatment.

conclusionThis pharmacovigilance study aligned with established clinical observations. Additionally, novel AEs associated with fruquintinib therapy were detected, offering valuable evidence to enhance clinical surveillance strategies and risk assessment protocols.