Abstract：OBJECTIVE To detect and analyze signals of tolvaptan related adverse events of death through data mining methods based on FAERS data. METHODSE Downloaded 60 quarters of FARES data from 2004Q1 to 2018Q4. After drug names standardized by MedEx and adverse events classified by MedDRA, searched tolvaptan related to death events reports, and detected the ADE signal using ROR and PRR methods. RESULTS A total of 4 641 reports of tolvaptan were gathered, including 360 death reports, PRR=1.90, χ2=158.59, the signal of death wasn′t detected. However, the lower limit of ROR 95%CL=1.72, the signal of death was detected. There were significant differences between the two methods. The signal of subgroup of death were detected by both methods, a=8, PRR=2.29, χ2=5.72, the lower limit of ROR 95%CI=2.28. In the death reports, 41.39% were old patients(＞65 years old), there were cases suffering multiple comorbidities and using multiple drugs. CONCLUSION The potential death risk of tolvaptan should be paid attention to, especially the old patients and drug-drug interactions should be strictly monitored.
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2020, Vol. 55 
