ORIGINAL RESEARCH article
Front. Oncol.
Sec. Cancer Molecular Targets and Therapeutics
This article is part of the Research TopicMolecular Mechanisms and Innovative Therapies for Advancing Cancer TreatmentView all articles
Characterization of Ocular Adverse Events Associated with Crizotinib: Real-World Insights from the Two Global Pharmacovigilance Databases of FAERS and VigiBase
Provisionally accepted
- 1Dalian No.3 People's Hospital, Dalian, China
- 2Dalian City Third People's Hospital, Dalian, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
To evaluate the risk of ocular adverse events (AEs) associated with crizotinib using real-world data from FAERS and VigiBase, and to characterize signal patterns through disproportionality and time-to-onset (TTO) analyses. Reports from FAERS and VigiBase (2011–2025) were analyzed. Disproportionality was assessed using reporting odds ratio (ROR) at both system organ class (SOC) and preferred term (PT) levels. TTO analysis was estimated based on FAERS data. Crizotinib was consistently associated with ocular AEs across both databases (FAERS ROR = 3.46, 95% confidence interval [CI]: 3.30–3.63; VigiBase ROR = 3.34, 95% CI: 3.17–3.51). Frequent PTs included visual impairment, blurred vision, and photopsia. High RORs were also observed for common events such as photopsia (FAERS: ROR = 42.5; VigiBase: ROR = 49.42) and visual brightness (FAERS: ROR = 31.67; VigiBase: ROR = 214.25). The median TTO was 14 days, suggesting early onset during treatment. Crizotinib is associated with a distinct profile of ocular AEs, typically mild and early in onset. The detection of rare but strongly associated PTs underscores the need for routine ophthalmologic monitoring. These findings are biologically plausible, as crizotinib inhibits the MET and ROS1 signaling pathways, both of which are expressed in retinal tissue, thereby supporting the need for enhanced clinical vigilance in patients receiving crizotinib.
Keywords: crizotinib, Ocular adverse events, FAERS, VigiBase, Disproportionality analysis
Received: 29 Oct 2025; Accepted: 25 Nov 2025.
Copyright: © 2025 Dong, Jiang, Gao, Zhang and Liu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Shuai Dong
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.