Clinical safety study of omeprazole based on 5-year adverse drug reaction monitoring data in Guizhou province
Objective To describe the characteristics of adverse reactions(ADR)caused by omeprazole and estimate the risk of occurrence based on the 5-year ADR monitoring data,to provide safety data for the comprehensive clinical evaluation of drugs.Methods The ADR information caused by omeprazole received by the Guizhou Provincial Adverse Drug Reaction Monitoring Center from January 2018 to September 2023 was retrospectively retrieved,and the report items were standardized using the MedDRA terminology.Patient demographics,ADR distribution characteristics,and ADR risks associated with different routes of administration were analyzed.Results A total of 2048 ADR reports(3363 cases)were included,of which 58.94%were women,4.59%were children,and 6.64%were severe ADR.The skin and subcutaneous tissue,gastrointestinal system,and nervous system were the most common sites of ADRs caused by omeprazole.Compared to oral administration,intravenous administration had a higher risk of ADRs(RR=15.46,95%CI:12.40 to 19.26).Conclusion Based on the analysis of 5-year ADR monitoring data in Guizhou Province,omeprazole demonstrated good short-term safety,but the risk of ADRs was higher with intravenous administration.Enhanced monitoring is recommended for long-term use.
万方数据
维普
