BackgroundHighly active antiretroviral therapy (HAART) has reduced the morbidity associated with HIV infection, and prolonged the lifespan of HIV/AIDS patients [1,2], but reports of morbidity and mortality from adverse reactions (ADRs) associated with the antiretroviral (ARV) drugs have tended to reduce these benefits [3][4][5]. In Africa and most resource-limited economics, the incidence of ADRs and toxicities have been shown to be responsible for frequent changes in first-line antiretroviral therapy (ART), and/or to the few available second-line regimens [4,5]. The first-line ART consist of the generic, fixed-dose combination (FDC) regimen of stavudine (d4T) or zidovudine (AZT) plus lamivudine (3TC) and nevirapine (NVP) or efavirenz (EFV) [6], although tenofovir disoproxilfumarate (TDF) plus 3TC or emtricitabine (FTC) and NVP or EFV combination regimens can be found in some settings [7]. The second-line ART comprises the protease inhibitors [ritonavir-boosted lopinavir (LPV/r)] plus TDF/FTC plus either AZT, d4T, or didanosine (ddl) [4,7].Within the past decade, the World Health Organization (WHO) made ARV-associated ADRs the focus of many studies in patient safety and quality control, with the recognition that prevention of potential ADRs is a key element of efforts to improve patient care. This was sequel to increasing reports of ADRs and toxicities associated with the use of the first-line regimens from both developing and the developed countries [5,[8][9][10][11]. These reports led to the revision of ART guidelines which recommended, among other things, the reduction of the dose of d4T from 40mg to 30mg for all patients, irrespective of body weight; the substitution of d4T with AZT or TDF in the presence of d4T toxicity, and of NVP with EFV in females and males with baseline CD4+ cell counts above 250 /µl and 400 /µl respectively [12][13][14][15].Because ADRs may be influenced by many factors, it is necessary to monitor patients on ART by keeping accurate information on their morbidity. Such information can be helpful as a guide to the AbstractBackground: Highly active antiretroviral therapy (HAART) has reduced the morbidity associated with HIV infection, and prolonged the lifespan of HIV/AIDS patients, but reports of adverse reactions associated with the antiretroviral drugs exist in the literature. The aim of this research was to determine the frequency and pattern of adverse drug reactions (ADRs) in HAART-experienced patients in our facility from

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