Mining and analysis of adverse drug reaction signals of deflazacort based on FAERS database
Objective To mine the adverse drug reaction signals of deflazacort to provide reference for its safe and rational clinical use.Methods The ADE reports of deflazacort reported in the FAERS database for a to-tal of 26 quarters from the 1st quarter of 2017 to the 2nd quarter of 2023 were data-mined using the report ratio ratio method and the proportion report ratio method,and the basic information such as gender,age and other basic information of the reported cases were counted and analysed for new ADE signals.Results There were 3 265 ADE reports with deflazacort as the suspected drug,the age was mainly under 18 years old;the year of reporting was mainly concentrated in 2019;and the main reporting country was the United States.A total of 145 ADE sig-nals were obtained from mining,involving 27 system and organ classifications,mainly focusing on various types of injuries,poisoning and operation complications,psychiatric disorders,systemic diseases and various reactions at the site of drug administration.The top 3 signals in terms of intensity were tendon rupture,like Cushing syndrome and growth retardation in that order.Some new ADE signals such as fat embolism,ligament sprain and vomiting were also identified.Conclusion In the clinical application of deflazacort,patients should be closely monitored for the occurrence of events mentioned in the specification,such as tendon rupture,like Cushing syndrome and growth retardation,and be alert to ADEs not mentioned in the specification,so that preventive and curative mea-sures can be taken in a timely manner to reduce the risk of clinical use of the drug.
Drug-related side effects and adverse reactionsDeflazacortFAERS databaseSignal miningReporting odds ratioProportional reporting ratio