Gender differences in adverse drug reactions reported to the national pharmacovigilance centre in the Netherlands An explorative observational study.

AIMS: We aimed to assess and characterize gender differences in adverse drug reactions (ADRs) reported to the national pharmacovigilance centre in the Netherlands while taking into account differences in drug use.

METHODS: ADRs spontaneously reported by healthcare professionals and patients to the Netherlands pharmacovigilance centre Lareb were used. Drug-ADR combinations reported at least 10 times between 2003-2016 for drugs used by ≥10,000 persons in that period were included. Data about the number of drug users was obtained from the National Health Care Institute. Gender-specific ADRs, like gynaecological problems, were excluded. Gender differences in specific drug-ADR combinations were tested using bivariate logistic regression analyses in which the number of drug users per gender was taken into account.

RESULTS: In total 2,483 drug-ADR combinations were analysed. Possibly relevant gender differences were shown in 363 combinations (15%). Most of these drug-ADR combinations were reported more often for women (322 combinations). Drugs with the highest number of ADRs that were more often reported for women included thyroid hormones (32 combinations) and antidepressants (16 combinations for the centrally acting sympathomimetics; 14 combinations for other antidepressants). Some ADRs were predominantly reported for women across a range of drugs like headache and dizziness whereas other ADRs like tendon ruptures and aggression were reported more often for men.

CONCLUSIONS: Identified gender differences in reported ADRs often referred to women. These differences may have various causes, including pharmacological and behavioural causes, which need to be further assessed. The results may ultimately lead to gender-specific prescribing or monitoring recommendations.