Gender differences in adverse drug reactions: analysis of spontaneous reports to a Regional Pharmacovigilance Centre in France

Abstract

The aim of this study was to investigate putative gender-related differences in adverse drug reactions (ADRs). Data were ADRs recorded in the database of the French Midi-Pyrénées Pharmacovigilance Centre in 1998. A total of 927 ADRs were spontaneously reported to the Centre in 1998, of which 53.1% were in females (difference vs. males not statistically significant). There was no statistically significant difference in the incidence of reported ADRs in males (3.6/10 000 inhabitants) vs. females (3.9/10 000 inhabitants) for the total population of the Midi-Pyrénées area. The number of reported ADRs was similar across different age groups (10-year age ranges). However, ‘serious’ ADRs were more frequently reported in males in the 0–9 and 60–69 age groups (and in females between 20 and 29 years old). There were significantly more neuropsychiatric (69 vs. 43, P=0.05) and fewer cardiovascular (8 vs. 2, P=0.05) ADRs reported in females than in males. ADRs were more frequently reported in females for some classes of drugs (such as genito-urinary, sex hormone, antineoplastic, antiparasitic and respiratory drugs). These results confirm that female gender is a risk factor for the development of ADRs.