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Sex Differences in Adverse Drug Reactions Using the Korea Institute of Drug Safety and Risk Management Database

The aim of this study was to assess and characterize sex differences in adverse drug reactions (ADRs) reported to the Korea Institute of Drug Safety and Risk Management (KIDS). This retrospective pharmacoepidemiological study was performed using the Korea Adverse Event Reporting System (KAERS) database from the KIDS in 2014-2018. Variables used in the analyses include sex and age of patients, suspected drug, type and severity of ADR, and severity of ADR. A ratio of reports concerning women and men was calculated for ADRs reported. A dataset of 22 drugs selected from the FDA label and UpToDate？？ database were requested to KIDS. Among 22 drugs, 17 of them were reported as suspected drugs to cause ADR and these were further analyzed in detail. The total reported number of ADRs was 241,974 and reports from female patients comprised of 54.5%. Aprepitant had the highest number of ADR reports (n=179,716), followed by fluorouracil (n=17,807), oxycodone (n=14,643) and cisplatin (n=14,191). Reports of serious adverse events were mostly from aprepitant and evidently high in female patients in aprepitant. Sex differences exist in ADRs based on KIDS-KAERS database which varies among drugs and type of ADRs. Further studies are warranted to examine details of clinical information of patients to conclude gender differences in adverse drug reactions.