Abstract
Background:
AIDS is one of the most destructive epidemics witnessed by the modern world. The anti retroviral drugs used to treat HIV infection come with adverse drug reactions which can be treatment limiting or affect the adherence to therapy. Exploration of the same will help in improving treatment outcomes.

Objectives:
To assess the adverse drug reactions (ADRs) to antiretroviral therapy (ART) among paediatric patients of HIV.

Materials and Methods:
After obtaining approval from the institutional ethics committee, a cross-sectional, observational study was conducted among 134 HIV/AIDS patients aged < 15 years. Patients who were on ART since 6 months were included in the study. Written and informed consent was obtained from the participant or the guardian. The study was conducted in the Department of Paediatrics, KIMS, Hubballi. The data was collected by self report by the care giver or the child regarding treatment adherence over the past month and ADRs experienced by them during the course of therapy, using a questionnaire. Confidentiality of patients was maintained throughout and after the study.

Results:
The most common time of occurrence of ADR was within the first 2 months of initiation of ART and the most common ADR was nausea and vomiting. 76.9% ADRs were ‘probable’ on Naranjo causality assessment and 92.3% were mild in nature. A statistically significant association was seen between adherence and ADRs. Occurrence of ADRs was found to be higher among patients who were on ZDV+LMV+ EFV regimen.

Conclusion:
Occurrence of ADRs was seen to significantly influence the adherence to ART. As efforts continue in the development of medications with more favourable adverse effect profiles, treating physicians must remain aware of new and developing syndromes associated with the use of these drugs.
Keywords: adverse drug reactions; paediatric; antiretroviral therapy.

Key words: Adverse drug reactions; Paediatric; Antiretroviral therapy.