Abstract: OBJECTIVE To mine and analysis the adverse drug reaction(ADR) signals of the new antitumor drug pralsetinib, in order to provide references for safe clinical medication. METHODS Based on data of Center for ADR Monitoring of Hainan Province from September 2020 to July 2021, the ROR and the MHRA were adopted to mine the ADR risk signals of pralsetinib. RESULTS According to System Organ Classification in the Medical Dictionary for Regular Activities, the ADR damage of pralsetinib was mainly concentrated in various examination indicators(39.6%), blood and lymphatic system diseases(20.8%), and hepatobiliary system diseases(14.6%); Five ADR risk signals of pralsetinib had been mined by the ROR and the MHRA methods, which were granulocytopenia, myelosuppression, hepatic function abnormal, alanine aminotransferase increase, aspartate aminotransferase increase. In clinical medication, that still needed to be alert to some suspicious signals such as renal impairment, acute myocardial infarction, especially the potential adverse reactions not mentioned in the instructions. CONCLUSION ADR risk signals of pralsetinib are effectively mined by the ROR and the MHRA methods. In clinical medication, attention should be paid to the ADRs of plastectinib, in order to provide references for safe clinical medication.