Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century

Global post marketing surveillance data on spontaneous reports indicate that women, from puberty and onwards and especially in their reproductive years, report more ADRs than men. However, there is a higher proportion of serious and fatal ADRs among male reports. Our results suggest important underlying sex-related differences in ADRs. These findings highlight the importance of considering sex throughout the entire life-cycle of drug development and surveillance and understanding the underlying reasons for reporting ADRs.