BackgroundIbuprofen is a non-steroidal anti-inflam-matory drug frequently administered to children of var-ious ages for relief of fever and pain and is approved as over-the-counter medication in many countries world-wide. Although there is extensive data on its efficacy and safety in children and adults, there are divergent dosing recommendations for analgesia and treatment of fever in infants, especially in the age group between 3 and 6 months of age. The purpose of this analysis was to assess the safety and efficacy profile of ibuprofen in this age group in an attempt to optimise pain and fever manage-ment.MethodsA comprehensive PubMed search was con-ducted in order to identify publications concerning the use of ibuprofen in infants younger than 6 months of age. Identified studies were reviewed so that only those pre-senting original clinical data regarding the pharmacoki-netics, safety or efficacy of ibuprofen in infants younger than 6 months would be included.ResultsThe literature search identified 5 pharmacoki-netic and 10 efficacy and safety studies which met the re-view inclusion criteria. Eligible PK studies presented data of 243 children, which included at least 18 infants under the age of 6 months. Eligible efficacy and safety studies contained data of 39 234 children including minimum 207 children younger than 6 months. The most common underlying pathological condition was fever. The most common clinical setting was outpatient care.ConclusionBased on the current evidence, short-term use of ibuprofen is considered safe in infants older than 3 months of age having a body weight of more than 5–6 kg when special attention is given to the patient’s hydration. Ibuprofen should be prescribed based on body weight using a dose of 5–10 mg/kg. This dose can be adminis-tered 3–4 times a day resulting in a total daily dose of max-imally 30–40 mg/kg. The rectal route has been shown to be less reliable because of erratic absorption, especially in young infants. Since most efficacy and safety data have been derived from paediatric trials in infants with fever, future studies should focus on the efficacy of ibuprofen in young infants with pain.