Mining and analysis of adverse event signals of ripretinib based on FAERS database
Objective FAERS database was used to mine adverse drug event signals of ripretinib after marketing in order to evaluate its safety in the real world after marketing and provide reference for clinical use.Methods The data from the second quarter of 2020 to the second quarter of 2024 in the FAERS database were extracted,cleaned,and standardized.Adverse drug event reports with ripretinib as the main suspected drug were screened.The ROR,PRR,and BCPNN methods were used to jointly mine adverse drug event signals.Results A total of 11 469 adverse drug event reports with ripretinib as the primary suspected drug were collected,involving 3 250 patients,and the proportion of male patients was higher than that of female patients(54.28%vs 43.63%).A total of 131 risk signals related to adverse drug event were excavated,and the top 5 adverse drug event s were fatigue,alopecia,death,disease progression,and progressive tumors.The top 5 adverse drug reaction signals not included in the instructions were abnormal hair structure,liver metastasis,bleeding gums,dysphonia,and decreased serum potassium.Conclusion Although ripretinib exhibits potential adverse drug event signals in clinical applications,the overall safety analysis based on the FAERS database suggests that it remains within an acceptable range.However,the frequent adverse reactions that may be caused by ripretinib and adverse reactions not recorded in the label,such as liver metastases and liver tumors,need to be of concern.Therefore,clinical pharmacists and physicians should pay close attention to these risks and develop and implement effective prevention and management measures to ensure the safety and efficacy of ripretinib in clinical use.
ripretinibpost-marketing safety evaluationdata miningadverse drug eventfatiguehair lossabnormal hair structurehepatic metastases
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万方数据
