Following the change in malaria policy in the year 2005, the safety profile of Artemether- Lumefantrine was assessed among children below ten years that presented with uncomplicated malaria in the University of Benin Teaching Hospital, Benin City, Nigeria, between January and December 2007. Designed questionnaire were systematically distributed among one thousand five hundred children that were recruited for the study. The children were aged 4.8±3.14years, body weight 21±4.12kg. At therapeutic doses 1399 [93.27%] patients reported with nine systemic and forty-one types of side effects. Body weakness [32.00%] was the most frequently reported, followed by Dizziness [31.00]%. Other side-effects were fever [9.00%], insomnia [5.00%], itching [0.13%], blurred vision [5.92%], increased heart beat [3.42%], stomach upset [0.10%] , headache [2.62%], confusion\anxiety [1.09%], diarrhea [0.90%], loss of appetite [3.07%], convulsion [0.16%], change in urine color [3.55%], ear pain [0.12%]. The side-effects were dependent on the ages of the patients [p<0.05, Chi-square] and most frequent between ages 8 and 10years. None was hospitalized as a result of side-effect no death recorded during therapy. It was observed that 0.73% reported with severe malaria and they were treated with either quinine or artemether at 10mg\kg and 1.6mg\kg respectively. 2.27% had spinal meningitides and were treated with penicillin or cephalosporin class of antibiotic. Artemether- Lumefantrine was safe and well tolerated in this study, it is therefore recommended for the treatment of uncomplicated malaria children below ten years.
