Reporting on Adverse Clinical Events

Abstract

A national cross-sectional study evaluated the incidence and characteristics of adverse drug events by sex using adverse drug event data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) and drug use data from the Medical Expenditure Panel Survey (MEPS). Approximately 20 million adverse events were identified in the FAERS database, of which 63.3% (12.6 million) were documented in women. The median number of adverse event reports in females was 45.1% higher than those in men. When adjusted by drug use, women had a median number of adverse events 15% higher than men. Based on the results of this national cross-sectional study