Efficacy and safety of acetaminophen vs ibuprofen for treating children's pain or fever: a meta-analysis

Arch Pediatr Adolesc Med. 2004 Jun;158(6):521-6. doi: 10.1001/archpedi.158.6.521.


Objective: To summarize studies testing the efficacy and safety of single-dose acetaminophen and ibuprofen for treating children's pain or fever.

Data sources: Reports were gathered by searching computerized databases (from their inception through May 2002) and registries, relevant journals, and bibliographies of key articles.

Study selection: Seventeen blinded, randomized controlled trials with children (<18 years) receiving either drug to treat fever or moderate to severe pain.

Data extraction: Under a fixed-effects model, outcome measures for an initial single dose of ibuprofen vs acetaminophen were the risk ratio for achieving more than 50% of maximum pain relief, effect size for febrile temperature reduction, and risk ratio for minor and major harm.

Data synthesis: Ibuprofen (4-10 mg/kg) and acetaminophen (7-15 mg/kg) showed comparable efficacy (3 pain relief trials; 186 children). The risk ratio point estimates was 1.14 (95%confidence interval [CI], 0.82-1.58) at 2 hours after receiving the dose, and 1.11 (95% CI, 0.89-1.38) at 4 hours. Ibuprofen (5-10 mg/kg) reduced temperature more than acetaminophen (10-15 mg/kg) at 2, 4, and 6 hours after treatment (respective weighted-effect sizes: 0.19 [95% CI, 0.05-0.33], 0.31 [95% CI, 0.19-0.44], and 0.33 [95% CI, 0.19-0.47]) (9 fever trials; 1078 children). For ibuprofen 10 mg/kg (acetaminophen, 10-15 mg/kg), corresponding effect sizes were 0.34 (95% CI, 0.12-0.56), 0.81 (95% CI, 0.56-1.03), and 0.66 (95% CI, 0.44-0.87). There was no evidence the drugs differed from each other (or placebo) in incidence of minor or major harm (17 safety trials; 1820 children).

Conclusions: In children, single doses of ibuprofen (4-10 mg/kg) and acetaminophen (7-15 mg/kg) have similar efficacy for relieving moderate to severe pain, and similar safety as analgesics or antipyretics. Ibuprofen (5-10 mg/kg) was a more effective antipyretic than acetaminophen (10-15 mg/kg) at 2, 4, and 6 hours posttreatment.

Publication types

  • Comparative Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Acetaminophen / therapeutic use*
  • Adolescent
  • Analgesics, Non-Narcotic / therapeutic use*
  • Child
  • Child, Preschool
  • Fever / drug therapy*
  • Humans
  • Ibuprofen / therapeutic use*
  • Infant
  • Infant, Newborn
  • Odds Ratio
  • Pain / drug therapy*
  • Randomized Controlled Trials as Topic
  • Treatment Outcome


  • Analgesics, Non-Narcotic
  • Acetaminophen
  • Ibuprofen