An assessment of the safety of pediatric ibuprofen: a practitioner-based randomized clinical trial

Short-term use of ibuprofen in feverish children does not appear to significantly increase the risk of hospitalization for gastrointestinal bleeding, kidney failure, or anaphylaxis. Researchers followed 83,915 children who took fever-reducing medications. Of these, approximately one-third took 12 milligrams of acetaminophen per kilogram of body weight (mg/kg) and two-thirds took ibuprofen in five mg/kg or 10 mg/kg doses. At the four-week follow-up, four children had been hospitalized for treatment of gastrointestinal bleeding. All of these children had taken ibuprofen. The risk of gastrointestinal bleeding was 7.2 cases per 100,000 ibuprofen-treated children and no cases per 100,000 acetaminophen-treated children. No children were hospitalized for anaphylaxis, acute kidney failure, or Reye's syndrome.