Background Adverse drug reactions (ADRs) are a major burden in healthcare. The scientific literature indicates that women tend to have a higher risk of ADRs than men due to differences in pharmacokinetics, pharmacodynamics and drug use.

Purpose The aim of this study was to investigate the gender related differences in ADRs between the sexes in an Italian populations during a 15 year period of observation.

Material and methods Data were obtained from the Italian National Network of Pharmacovigilance and we focused our attention on ADRs in the period between 2001 and 2016. We identified the ATC (Anatomic, Therapeutic, Chemical Classification) most reported ADRs, seriousness of ADRs and sex.

Results During the observation period, we collected 341 599 ADRs: woman had a higher risk of ADRs, especially after the first 2 years (55.4%). Severe ADRs were more frequent in women than in men (54% versus 46%). In contrast, the frequency of death was higher in men than in women (54% versus 46%). Major toxicity was reported for this ATC: H03AA, thyroid hormones, women 80%-men 20%; J01CA, broad-spectrum penicillins, women 57%-men 43%; J01CR associations of penicillins, including beta-lactamase inhibitors, women 57%-men 43%; J05AE, protease inhibitors, women 26%-men 74%; J05AF reverse transcriptase inhibitors nucleoside, women 33%-men 67%; J07BB, flu vaccines, women 59%-men 41%; M01AB anti-inflammatory and antirheumatic drugs acetic acid derivatives and related substances, women 61%-men 39%; M01AC anti-inflammatory and antirheumatic drugs oxicam derivatives, women 64%-men 36%; M01AE anti-inflammatory and antirheumatic drugs propionic acid derivatives, women 58%-men 42%; M01AH anti-inflammatory and antirheumatic drugs coxibs, women 72%-men 28%; N05BA anxiolytic benzodiazepine derivatives, women 61%-men 39%; N06AB antidepressants selective serotonin reuptake inhibitors, women 64%-men 36%; P01BA antimalarials aminochinolines, women 58%-men 42%.

Conclusion Previous data suggested that ADRs are more frequent and severe in women than in men but death mainly occurred in men. These data indicate the need to include women in clinical studies and the importance of monitoring ADRs to ensure safer drug therapy.

References and/or acknowledgements Stefano Stabile, et al. Gender difference as risk factor for adverse drug reactions: data analysis in salvini hospital.pharmacologyonline.silae.it

Ferioli B, et al. A gender pharmacovigilance study in Tuscany Region.

No conflict of interest