Signal mining and analysis of adverse drug events of azilsartan based on FAERS and JADER database
CHEN Qing-yu
MA Yin-ling
ZHAO Jian-qun
LIU Yu-kai
PANG Guo-xun
Abstract：Objective:To provide clinical safety supports for azilsartan through mining its potential adverse drug reaction signals based on the FDA Adverse Event Reporting System(FAERS)and Japanese Adverse Drug Event Report(JADER)database.Methods:The adverse drug reaction(ADR)reports were collected by retrieving the FAERS database from the first quarter of 2011 to the third quarter of 2024 and the JADER database from the second quarter of 2012 to the third quarter of 2024,and then classified and described by using the system organ class(SOC)and preferred term(PT)of the Medical Dictionary for Regulatory Activities.The suspicious positive signals were mined and analyzed by the method of reporting odds ratio(ROR)and proportional reporting ratio(PRR).Results:A total of 1660 ADR reports with azilsartan as the primary suspected drug were retrieved,including 753 cases from the FAERS database and 907 cases from the JADER database.After second screening of the data,a total of 312 ADR reports were obtained from the FAERS database,including 32 positive PT signals,involving 10 SOC.A total of 291 ADR reports were obtained from the JADER database,including 29 positive PT signals,involving 12 SOC.PT with high frequency includes hypotension,hyperkalemia,and renal dysfunction,and PT with high signal intensity includes hyperkalemia,pulmonary infarction,abnormal skin odor,and oral inflammatory diarrhea like bowel disease.New adverse reaction effects were discovered,including pulmonary infarction,hyponatremia,and hypoglycemia.Conclusion:In the clinical application of azilsartan,clinicians should be alert to electrolyte imbalance caused by long-term medication,such as hyperkalemia and hyponatremia,and regularly monitor ADR such as blood pressure,blood glucose,renal function damage,and pulmonary infarction,in order to optimize the safety of clinical medication.
Keywords：azilsartanadverse drug reactionFAERS databaseJADER database
Publication Date：2026-02-28
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：10( 432-441 )