Women encounter ADRs more often than do men.
BACKGROUND
Several publications indicate that the female gender experiences a higher incidence of adverse drug reactions (ADRs) than does the male gender. The reasons, however, remain unclear. Gender-specific differences in the pharmacokinetic and pharmacodynamic behaviour of drugs could not be identified as an explanation. The aim of this study was to analyse ADR risk with respect to gender, age and number of prescribed drugs.


METHODS
A prospective multicenter study based on intensive pharmacovigilance was conducted. Information on patient characteristics and evaluated ADRs was stored in a pharmacovigilance database--KLASSE.


RESULTS
In 2,371 patients (1,012 female subjects), 25,532 drugs were prescribed. In 782 patients, at least one ADR was found. A multivariate regression analysis adjusting for age, body mass index (BMI) and number of prescribed drugs showed a significant influence of female gender on the risk of encountering ADRs [odds ratio (OR) 1.596, confidence interval (CI) 1.31-1.94; p < 0.0001). Dose-related ADRs (51.8%) were the dominant type in female subjects. Comparing system organ classes of the World Health Organisation (SOC-WHO), cardiovascular (CV) ADRs were particularly frequent in female subjects (OR 1.92, CI 1.15-3.19; p = 0.012).


CONCLUSIONS
Our data confirm the higher risk of ADRs among female subjects compared with a male cohort. Several explanations were investigated. No single risk factor could be identified.
Zopf
Y
Y
Department of Medicine 1, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany. yurdaguel.zopf@uk-erlangen.de
Rabe
C
C
Neubert
A
A
Gassmann
K G
KG
Rascher
W
W
Hahn
E G
EG
Brune
K
K
Dormann
H
H
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D017677:Age Distribution; D000368:Aged; D015331:Cohort Studies; D016208:Databases, Factual; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D004364:Pharmaceutical Preparations / Q000145:classification; D017891:Pharmacoepidemiology; D015995:Prevalence; D011446:Prospective Studies; D012307:Risk Factors
D004364:Pharmaceutical Preparations