Characteristics of Adverse Drug Reactions and Related Risk Factors among Female Patients

Abstract

Abstract: Background and Objective: Previous studies have demonstrated that Gender-associated Adverse Drug Reactions (ADRs) were one of the leading causes of harm and/or death among patients during medical treatments. However, the ADRs focusing the female patients are very rare. This study aimed at exploring characteristics of ADRs and related risk factors among female patients in obstetrics and gynaecology hospital. Materials and Methods: A retrospective analysis was performed on 357 hospitalizations and outpatients from January, 2010-October, 2015 in our hospital. The ADRs that happened in the female patients were strictly monitored and reported by doctors after drug administration. ADRs were evaluated based on the WHO-Uppsala Monitoring Center criteria. Regression analysis via the Cox proportional hazards model was performed to assess independent predictive variables against the latency of ADR. Results: The most frequently ADRs were rash, vulvar, vaginal discomfort or nausea. The latency of ADR’s onset in patients ranged from several seconds to a couple of days and 0.5-24 hrs was the most frequently (n = 190, 53.22%) in general. Both age and allergy histories were positively correlated with the duration period of ADRs (hazard ratio HR 2.919, 95% CI 1.049-8.124 and HR 4.107, 95% CI 1.478-11.410). Conclusion: These data demonstrate the characteristics of the ADRs in female patients, to provide an increasing number of female-patient based ADR database and valuable data to study pharmacovigilance.