Objective  To provide references for clinical safe medication by mining and analyzing signals of ocular adverse events (ADE) related to anaplastic lymphoma kinase (ALK) inhibitors.

Methods  The data from the third quarter in 2011 to the first quarter in 2024 were downloaded from the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS), ocular ADEs associated with ALK inhibitors reports were extracted. The suspicious risk signals were mined and analyzed by reporting odds ratio (ROR) and information component (IC) method. The median occurrence time of ocular ADE was analyzed, and Weibull shape parameter test was used to analyze the relationship between ADE occurrence time and ALK inhibitor treatment time.

Results  A total of 1 575 reports of ALK inhibitor-related ocular ADEs were collected, including 1 107 reports for crizotinib, 50 reports for ceritinib, 158 reports for alectinib, 110 reports for brigatinib and 150 reports for lorlatinib. The proportion of female patients was higher (46.29%), and the main age distribution was between 18 and less than 65 years old (35.17%). No risk signal was detected for ceritinib. 13 ADE signals were obtained for crizotinib, alectinib, brigatinib and lorlatinib. Crizotinib ranked first in the number of ADE reports and positive signals, and the signal intensity of crizotinib-induced photopsia was the highest (ROR=43.46, 95%CI 36.38 to 51.91; IC=5.18, 95%CI 4.89 to 5.40). The median time to onset of most ocular ADEs was within one month of medication initiation, and the median time to onset of blindness caused by ALK inhibitors was the longest at 154.00 (114.50, 225.50) days. The visual impairment, vision blurred, photopsia, vitreous floatres and diplopia often occurred in the early stage of medication. The photophobia, visual field defect and blindness occurred randomly and did not change with treatment time.

Conclusion  The risk of ocular ADEs was different in different ALK inhibitors, most of which occurred in the early stage of the treatment. The ocular toxicity of ALK inhibitors should be recognized and treated in time for clinical application.

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