Background Malaria remains a public health problem in sub-Saharan Africa, especially amongst children and pregnant women. Artemisinin-based combination therapy (ACT) is now the treatment of choice. Adverse drug reactions (ADR) have been observed to ACTs. This study aims to determine the incidence, pattern of presentation and factors associated with ADRs to artemether-lumefantrine (AL) and artemisinin-piperaquine (AP) among children with acute uncomplicated malaria in Ibadan, Nigeria.

Methods Children aged 2–10 years with acute uncomplicated malaria who met the inclusion criteria, were enrolled, randomised to receive one of the study drugs (AL or AP) and followed up for 28 days. Monitoring for ADR was based on history from the parent/guardian and/or child regarding occurrences of treatment emergent signs and symptoms and on abnormalities of laboratory investigations (full blood count and blood chemistry). Causality assessment for the ADR was by the Naranjo algorithm scale while the severity was assessed using the Hartwig’s severity scale.

Results A total of 114 children were enrolled; six defaulted and were not available for follow-up. There were 61 (56.5%) males. The mean age of enrollees was 65.1±30.0 months. Fever was the most prevalent presenting complaint occurring in 108 (100%) enrollees. Observed ADRs were cough, diarrhoea, loss of appetite, abdominal pain, rash, fever, irritability, insomnia and headache but the differences were not statistically significant between the two groups. The incidence of ADR to both ACTs was 12/1000 patients per day. Prevalence of ADR to AL was 14% and for AP 11%; this was not statistically significant. All ADRs were mild. No notable associated factor to ADR was detected in this study.

Conclusion Both AL and AP were found to be safe in the study population.