Mining of adverse drug event risk signals of olmesartan based on FAERS database
Objective To analyze the ADE reports of olmesartan to provide reference for safe medication in clinic.Methods Using the OpenVigil2.1 platform to obtain olmesartan-related ADE reports from FAERS from the January 1,2004 to September 30,2023,and the reporting odds ratio(ROR),proportional reporting ratio(PRR)and Bayesian confidence propagation neural network(BCPNN)methods were used for data mining and analysis of ADE reports.Results A total of 120 264 ADE reports related to olmesartan were obtained,with slightly more women than men among ADE reports of known gender,age or region,with the largest proportion of ADE reports being 61—80 years of age and from North America.The ADE report of olmesartan involved 25 SOCs and 4 288 PTs,and seven positive SOC were detected,including gastrointestinal disorders,renal and urinary disorders,metabolism and nutrition disorders,etc.,and 819 positive signals were detected at the PT level.It mainly includes sprue-like enteropathy,weight decreased,diarrhoea,kidney injury,dizziness,etc.Conclusion The ADE signals detected in this study were generally consistent with the instructions,and some new potential ADE signals were also found,such as gastroesophageal reflux disease,haemorrhoids,constipation,haemorrhagic thyroid cyst,intestinal polyp,and so on,which are worthy of clinical attention.
olmesartanadverse drug eventFAERSdata mininggastroesophageal reflux diseasehemorrhoidsconstipation