A prospective observational study of adverse drug reactions to antiretroviral therapy: type and risk factors in a tertiary care teaching hospital

Background: To collect demographic details of patients receiving antiretroviral therapy (ART) and study type of adverse drug reactions (ADRs) and risk factors for ADRs to ART and to assess causality, severity, and preventability assessment of the reported ADRs. Methods: A prospective observational study was conducted for 6 months from January 2012 until June 2012 at ART Center, KR Hospital of Mysore Medical College & Research Institute, Mysore. Data were evaluated for patient demography, risk factors for ADRs, type of ADRs. ADRs were also assessed for their causality, severity, and preventability as per the standard algorithm, using SPSS for windows (version 16.0). Results: Out of 158 patients evaluated, majority were of age group of 21-40 years (66.5%). More number of illiterate patients (55.7%) showed ADRs to ART. Most patients were of CD4 count