ABSTRACT
Background: South Africa has the highest number of patients on antiretroviral therapy (ART) globally. Various obstacles were identified that influence effective reporting of adverse drug reactions (ADRs) in resource-limited countries. This investigation aimed to identify, classify and analyse the prevalence of ART-related ADRs. Methods: This observational, quantitative and retrospective descriptive investigation utilised ADR forms completed by healthcare professionals in various healthcare facilities in the Tlokwe district, South Africa (January 2010 to December 2014). Descriptive and inferential analyses were carried out. Results: A total of 770 ART-related ADRs were included in the final analysis. The mean age was 40.1 (± 10.1%) years, with significantly higher ADRs reported in females (70.8%). In this study, 99% of the ADRs were reported by doctors. Abnormal fat distribution (58%), peripheral neuropathy (21.6%) and renal dysfunction (6.6%) were most frequently reported. Females presented with abnormal fat distribution and peripheral neuropathy at a significantly younger age (38.1 ± 4.6 vs. 43.4 ± 5.7 years, p < 0.0001 and 39.7 ± 1.1 vs. 45.1 ± 9.2 years, p < 0.001) respectively compared with males. Gender difference was practically significant (Cramer's V = 0.3) for all three of the major reported ADRs. Conclusions: Gender was highly dependent among the major reported ADR categories, and women presented with abnormal fat distribution and peripheral neuropathy at a significantly earlier age than males. This retrospective analysis can serve as aplatform for future ADR studies within this district. Sustainable and continuous efforts should be made to train and create more awareness among healthcare workers in this district