Objective: The objective of the study was to assess the adverse drug reactions (ADRs) of antiretroviral therapy along with its causality, severity, and preventability.Method: A prospective as well as a retrospective observational study with a sample size of 260, jointly conducted in the Department of Pharmacology and antiretroviral therapy (ART) center of N.S.C.B. Medical College Jabalpur, India, from March 2016 to July 2017. We observed various ADRs to ART in human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients and assessed causality, severity, and preventability of the reported ADRs as per the standard scales.Results: A total of 260 patients were enrolled of which 220 (84.6%) patients developed a total of 425 ADRs. Maximum 51.7% of ADRs were caused by TLE followed by 37% with ZLN regimen. Most common ADRs were dizziness 18.6%, rashes 14.6%, anemia 10.6%, and vomiting 6.6%. Dizziness and rashes are mainly caused by TLE and ZLN regimen, respectively. Management of ADRs with a change in the regimen was applied as an interventional tool in 40% of the patients. Causality assessment as per the WHO-UMC scale showed that 55.5% of ADR were probable and 45.5% were possible. 84.5% of ADR was not preventable, while 15.5% of ADRs were probably preventable. 38% of ADRs were mild, 56% were moderate, and 6% were severe in nature.Conclusion: Antiretrovirals, however, the milestone for the treatment of HIV/AIDS have very high potential for developing ADRs. Hence, active pharmacovigilance is needed for not only safety of the patients but also compliance to the treatment which is necessary for optimal therapeutic outcomes and to improve quality of life.

Background: Weight gain and hyponatremia which is dilutional in nature, has been well known adverse effects associated with use of atypical antipsychotic medication but the plausible impact of dilutional hyponatremia on weight gain has not been explored.Methods: One hundred and three patients more than 18 years of age of either gender who were prescribed, olanzapine or risperidone, were tested for serum electrolytes (Na+ and K+) and gross metabolic parameters (weight and waist circumference) were measured for baseline and post drug testing.Results: Most common age group was 30-39 years of age in the patient study sample (n=103) with 38 (36.90%) patients were females while rest 63 (63.10%) were males. There was no significant association between serum sodium levels and weight gain was observed (p >0.05). It was observed that in olanzapine group 64% of the studied cases had weight gain whereas in risperidone group only 20.8% reported weight gain (p <0.001). There was significant association between olanzapine and increase in waist circumference over risperidone, irrespective to serum sodium status (x2=0.0148, p >0.05).Conclusions: Olanzapine was primarily responsible for weight gain and increase in waist circumference over risperidone. These gross metabolic parameters were not influenced by hyponatremia.