Results:

The search returned 9,424 unique articles, of which 356 were eligible for full-text screening. Most of these studies were excluded due to the lack of gender-specific data (n = 144, 40%) or because the study design did not match the search criteria (n = 96, 27%). Of the remaining articles (n = 116), 25 did not provide ADR data, 19 were written in a different language, 13 were duplicates, and for 48, the full text could not be located. The search identified 155 eligible records, of which only 11 (7%) reported ADR data for women and men separately. The 11 studies included 153,945 individuals with a mean age of 64 years (52-75 years) and included on average 25% women (13%-49%), which was similar to the 144 excluded studies (29%). Four studies (36%) reported more ADRs in women compared with men, while one study (9%) reported more ADRs in men. The remaining six studies (55%) reported no difference in ADRs between the sexes. Six studies were post hoc analyses from randomized clinical trials, two used data from healthcare insurance claims databases, and the remaining three used patient cohorts from HF clinics. Gender-stratified reporting of ADRs did not increase over the last decades. Three studies reported a higher risk of ACEI-related ADRs in women, one study showed higher digoxin-related mortality risk for women, and one study reported a higher risk of MRA-related ADRs in men. No gender differences in ADRs were reported for ARBs and beta-blockers. Gender-stratified data were not available for ivabradine.