Analysis of adverse reactions of ibrutinib with information component method

doi:10.19803/j.1672-8629.20210683

Abstract

Abstract: Objective To comprehensively and systematically explore the possible adverse drug reactions (ADR) of ibrutinib, and provide references for clinicians’ safe medication. Methods The ADR signals of ibrutinib were mined on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database using Information Component (IC) method. Results A total of 20 120 ADR reports of ibrutinib were included in FAERS database from the construction of the library to Jun 1, 2021, and 446 positive signals were detected, including two strong ADR signals with IC₀₂₅>5, which were Richter syndrome (IC₀₂₅ =5.67) and cerebral aspergillosis (IC₀₂₅ =5.05). The top 3 ADR were atrial fibrillation (n=982, IC₀₂₅=3.33, IC=3.44), fatigue (n=958, IC₀₂₅=0.36, IC=0.47), diarrhea (n=931, IC₀₂₅=0.64, IC=0.75), the reports of which also exceed 900. Conclusion Ibrutinib has more widespread ADR in multiple systems. Clinicians should pay full attention to its ADR, and take corresponding measures in time to ensure the safety of patients’ medication.

Key words: Ibrutinib, adverse drug reaction, disproportionate analysis, FAERS database

CLC Number:

ZHENG Yi, GUO Xiaojing, XU Jinfang, GUO Zhijian, CHI Lijie, CHEN Chenxin, LIANG Jizhou, WEI Lianhui, CHEN Xiao, YE Xiaofei, HE Jia. Analysis of adverse reactions of ibrutinib with information component method[J]. Chinese Journal of Pharmacovigilance, 2022, 19(11): 1228-1232.

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