Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) represent a class of targeted drugs that have changed the cancer therapy landscape. However, the anti-angiogenic effect of VEGFR-TKIs significantly increase the incidence of cardiovascular adverse events (AEs). In this study, we conducted a comprehensive analysis of VEGFR-TKI-related thromboembolic events (TEEs), using data from the FAERS database between the drug launch and the third quarter of 2023. Disproportionality analysis, including reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were used to explore the correlation between VEGFR-TKIs and TEEs. The total number of reported TEEs was 2688, representing 2.98% of all AEs associated with VEGFR-TKIs. A total of 17 and 12 preferred terms of arterial and venous thromboembolic events were observed in 8 VEGFR-TKIs. Lenvatinib, a VEGFR-TKI with low selectivity and high potency, exhibited the strongest TEE signal. A tendency of an increased signal of disproportionate reporting of TEEs was observed in sorafenib, regorafenib, and sunitinib. Indication, gender, age, drug class, concomitant medication and AEs may influence the occurrence of VEGFR-TKI-related TEEs. This study illustrates that TEEs are highly associated with VEGFR-TKIs, emphasizing the importance of screening for the TEE risks during VEGFR-TKI therapy.
Keywords: FAERS; Pharmacovigilance; Thromboembolic event; Vascular endothelial growth factor receptor tyrosine kinase inhibitor.
© 2025. The Author(s).