Abstract:Objective To explore the risk signals of zanubrutinib to provide reference for its clinical rational and safe use. Methods Data on adverse drug events (ADE) related to zanubrutinib from October 1, 2019 to September 30, 2023 were collected from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality measurement was used for data mining. The mined risk signals were classified and described by the preferred system organ class (SOC) and preferred term (PT) of the adverse drug reaction terminology set in the Medical Dictionary for Regulatory Activities (version 26.0). Results A total of 2 356 ADEs with the zanubrutinib as the primary suspected drug were extracted. The majority of reports came from the United States. The outcomes primarily involved hospitalization and death, and the number of reports showed an increasing annual trend. The disproportionality measurement of detection yielded 49 ADEs involving 15 SOCs. These signals mainly focused on injury, poisoning and procedural complications, skin and subcutaneous tissue disorders, and investigations. Additionally, 20 new ADEs were identified that were not included in the label, along with 12 important medical events (IMEs) that are included in the EU list of IMEs. Conclusion When clinically applying zanubrutinib, it is important to closely monitor patients for any adverse events and take appropriate measures to intervene in a timely manner.