Adverse event profile of crizotinib in real-world from the FAERS database: a 12-year pharmacovigilance study

作者：Huan Zhang, Yunrui Song, Fantong Xia, Yunchang Liu, Lu Zhang, Jieying Yang, Honglei Tu, Bin Long, Jiang-Dong Sui, Ying Wang · 发表于：BMC Pharmacology and Toxicology · 年份：2025 · DOI：10.1186/s40360-025-00859-6 · 被引用次数：14 · 研究领域：Lung Cancer Treatments and Mutations、Pharmacovigilance and Adverse Drug Reactions、Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis

AIM: Crizotinib, an anaplastic lymphoma kinase tyrosine kinase inhibitor (ALK-TKI). It gained approval from the U.S. Food and Drug Administration (FDA) specifically for treating ALK-positive non-small cell lung cancer (NSCLC). The objective of the present investigation was to evaluate adverse events (AEs) associated with crizotinib in real-world by employing data mining on the U.S. FDA Adverse Event Reporting System (FAERS). METHODS: Data encompassing AEs linked to crizotinib from 2011 to 2023 were gathered. Disproportionality analyses, which involved the utilization of reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS), were employed for analytical purposes. RESULTS: A total of 10,226 reports documenting crizotinib-associated AEs were extracted from the FAERS database. Out of these, 147 preferred terms (PTs) displaying significant disproportionality were identified concurrently across all four algorithms. The most frequently observed AEs included increased transaminases, bradycardia, prolonged QT, nausea, vomiting, diarrhea, constipation, visual impairment, and interstitial lung disease, which were consistent with previous reports from clinical trials. Additionally, unexpected significant AEs such as deep vein thrombosis, pneumocystis jirovecii pneumonia, gastrointestinal amyloidosis, and hepatic coma were also observed. CONCLUSION: Crizotinib offers therapeutic ...