OBJECTIVE To explore the risk signals of Entratinib adverse events(AE)and provide a reference for the safe clinical use of this drug.METHODS The US FDA Adverse Event Reporting System database was searched to collect AE reports from January 1,2019 to September 30,2022 with Entratinib as the primary suspect drug.The preferred terminology(PT)and system organ classification(SOC)of the International Dictionary of Medi-cal Terminology,version 26.0,were used to standardize and classify AEs,and the risk signal mining for the AEs of entretinib was performed using the report ratio(ROR)method,and AEs with≥3 reports,ROR≥2 and lower 95%confidence interval(CI)of ROR>1 were defined as positive signals.descriptive analysis was performed on the ob-tained positive PT signals.RESULTS The number of AE reports included in the analysis was 603,and 56 positive PTs involving 15 SOCs were obtained using the ROR method.The top 10 reported PTs were vertigo,renal impair-ment,taste disorder,and ataxia,all of which were common AEs in the instructions.7 of the 56 PTs were not included in the drug instructions.CONCLUSION This study was based on the FAERS database to mine the ADR signals for Entratinib,using the Open Vigil 2.1 data platform to assist in data mining.7 of the 56 positive signals had ADR sig-nals that were not mentioned in the instructions.It is recommended that clinical applications should be given attention and timely interventions should be taken to ensure patient safety if relevant ADRs occur.