Gender differences in the occurrences and pattern of adverse drug reactions in psychiatric patients: A prospective observational study

Background: The female gender appears to suffer from more adverse drug reactions (ADRs) than the male gender. There are lacunae in epidemiologic studies analyzing gender-based differences in the ADR risks of patient with mental illness. Aim: The aim of this study was to establish a drug risk stratification adjusted to age, number of prescriptions, and drug classes with respect to gender differences. Setting: Prospective study was conducted in mental Health Department of a Tertiary Care Hospital over a period of 2 years. Materials and Methods: Patients of either sex or age prescribed with at least one psychotropic agent were included and monitored for ADRs. Results: A total of 775 ADRs were identified from 426 patients giving an overall incidence rate of 35.5%. Incidence of ADRs in male and females were 33.6% and 45.9%, respectively (adjusted odds ratio [OR], 1.6, 95% confidence interval [CI]: 1.26-2.05, P < 0.001). Female gender was found to be a significant risk factor in age Group 1 (adjusted OR, 1.55, 95% CI: 1.19-2.02, P = 0.001) and Group 2 (adjusted OR, 2.90, 95% CI: 1.01-8.28, P = 0.047). Furthermore, female patients receiving more drugs are at high risk of developing ADRs than the male [OR, 1.72, 95% CI: 1.14-2.72, P = 0.011 for Group 1 and OR, 1.83, 95% CI: 1.12-2.97, P = 0.015 for Group 2]. Conclusion: The incidence rate of ADRs is much higher (45.9) in females than the males with mental illness. To heighten drug safety for females, the complex interaction between pharmacokinetics, pharmacodynamics, and pharmacogenetics needs further research.