Abstract： Objective To provide reference for clinical rational drug use through signal mining analysis of adverse event(AEs)of Vandetanib drugs.Methods Obtain 48 quarterly reports on AEs related to Vandetanib from the US FAERS database from the second quarter of 2011 to the first quarter of 2023.Use the ROR method and the MHRA method to describe and classify AEs based on the SOC and PT in the ADR terminology set of the International Medical Dictionary(26.0 edition).Results A total of 1721 AEs reports were retrieved with Vandetanib as the primary suspected drug.Through ROR and MHRA methods,187 effective AEs signals were identified,involving 20 systemic organ classifications.Among them,47 signals were not mentioned in the drug instructions of Vandetanib,including tumor lysis syndrome,skin discoloration,skin exfoliation,and pigmentation disorders in skin and subcutaneous tissue diseases.The median time for the occurrence of AEs with Vandetanib was 40 days,and most AEs occured within the month prior to taking Vandetanib.Conclusion The common AE signals mined are consistent with the drug instructions;in clinical use,special attention should be paid to adverse events such as tumor lysis syndrome,skin discoloration,skin exfoliation,and pigmentation disorders that are not mentioned in the drug instructions.Patients should be closely monitored for abnormal skin and laboratory indicators,and timely intervention should be given to ensure the safety of medication for patients.