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Adverse Event Profiles of Acetaminophen and Ibuprofen in Infants: A Food and Drug Administration Adverse Event

Yaqing Bao1, Hai-Feng Lv2, Xing Li3

  • 1Department of Pharmacy, Ningbo University Affiliated Women and Children's Hospital, Ningbo, China.

Turkish Archives of Pediatrics
|November 19, 2025
PubMed

Insights

Acetaminophen and ibuprofen show distinct infant safety profiles. Acetaminophen is linked to more liver and nervous system issues, while ibuprofen is associated with fewer general and kidney problems, guiding safer fever management.

Area of Science:

  • Pediatric Pharmacology
  • Drug Safety Surveillance
  • Pharmacovigilance

Background:

  • Acetaminophen and ibuprofen are common antipyretics in infants.
  • Understanding their comparative safety profiles is crucial for clinical practice.
  • The U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database offers valuable real-world safety data.

Purpose of the Study:

  • To analyze and compare adverse events (AEs) associated with acetaminophen and ibuprofen in infants.
  • To identify significant safety differences between these two commonly used medications.
  • To provide evidence-based guidance for clinicians in pediatric fever management.

Main Methods:

  • Utilized the FAERS database for adverse event data.
  • Employed Proportional Reporting Ratio, Reporting Odds Ratio, and Bayesian Confidence Propagation Neural Network for signal detection.
  • Classified identified AE signals by System Organ Class (SOC) for detailed analysis.

Main Results:

  • Acetaminophen use in infants was associated with a higher incidence of hepatobiliary and nervous system disorders compared to ibuprofen.
  • Ibuprofen use was linked to a lower risk of general disorders and administration site conditions, as well as renal and urinary disorders.
  • Significant statistical differences were observed in AE profiles between the two drugs.

Conclusions:

  • This study reveals significant safety distinctions between acetaminophen and ibuprofen in infants.
  • Findings support informed clinical decision-making for selecting safer antipyretic agents.
  • Optimized fever management can be achieved by minimizing drug-related adverse events in pediatric populations.
Abstract

Keywords:
AcetaminophenFAERSadverse eventsibuprofenpharmacovigilance

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