A real-world drug safety surveillance study of lenvatinib from the FAERS database.

Background: There is a need to determine lenvatinib-associated real-world adverse events (AEs) as its adverse effects may result in its discontinuation.

Research design and methods: Lenvatinib-associated AEs were analyzed and quantified and risk signals from the first quarter of 2015 to the fourth quarter of 2023 were detected through data mining. Potential targets for lenvatinib-associated cholecystitis, cholangitis, and hepatic encephalopathy were identified by data mining.

Result: 68 Preferred Terms (PTs) with an important imbalance were kept. Unexpected AEs, such as immune-mediated hepatitis, portal vein thrombosis and adrenal insufficiency were associated with the use of lenvatinib use. Lenvatinib alone was more strongly associated with adrenal insufficiency than lenvatinib and pembrolizumab combination. Hepatic encephalopathy was more strongly correlated with drug use when Lenvatinib was administered to male patients with hepatocellular carcinoma. Most AEs occurred during the first month after treatment, with a median onset time of 41 days. FGFR4, PDGFRA, and KIT (Lenvatinib targets) are potentially linked to cholecystitis, cholangitis, and hepatic encephalopathy.

Conclusions: We identified Lenvatinib-associated AEs and discovered new AEs that will be useful for clinical monitoring and risk assessment.