Analysis of Adverse Drug Events with Bosentan Based on FAERS Database
Objective:To mine adverse event signals of bosentan based on the US Food and Drug Administration Adverse Event Reporting System(FAERS)and assess the drug's safety,so as to provide reference for the safe application of the drug in medical institutions.Methods:The data from the first quarter of 2016 to the second quarter of 2022 were searched from the FAERS database,and subsequently processed according to MedDRA for coding adverse events.The adverse event reports with bosentan as the primary suspect drug were extracted.The proportional reporting ratio(PRR)and report odds ratio(ROR)were used to detect signals.Results:The analysis of adverse event reports with bosentan as the primary suspect drug showed that the proportion of events reported in females(61.51%)was higher than that in males(21.40%).The analysis according to organ system class(SOC)revealed that adverse reactions with bosentan were mainly concentrated in general disorders and administration site conditions,respiratory,thoracic and mediastinal diseases,and infections and infestations;The analysis according to preferred terms(PT)showed that the top three events were dyspnoea,death,and pneumonia.The analysis according to low level term(LLT)found that bosentan frequently led to such adverse events as death,gene mutation,pulmonary edema,etc.Conclusion:Through mining the adverse reactions with bosentan using the FAERS database,the characteristics of adverse events were analyzed from SOC,PT and LLT levels,providing a reference for the safe use of bosentan in clinical practice.
bosentanFAERS databaseadverse drug reactions and eventssignal miningUS Food and Drug Administration
万方数据
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