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Ibuprofen and acetaminophen show comparable short-term safety in children with acute pain.
A systematic review and meta-analysis found no statistically significant difference in overall adverse events between ibuprofen and acetaminophen for acute pain in children and adolescents.
Why does the choice matter?
When treating acute pain in children, effective symptom control needs to be balanced with safety. Ibuprofen and acetaminophen (paracetamol) are widely used analgesics, but their different safety considerations can influence treatment decisions. Gastrointestinal, renal, hepatic, and bleeding-related events are among the safety outcomes that can influence analgesic selection, making comparative evidence clinically relevant in pediatric practice.
What did the evidence show?
The review included 15 studies involving 2,847 patients with acute pain related to postoperative recovery, musculoskeletal trauma, orthodontic procedures, and emergency department presentations.
For the primary analysis of any adverse event, 3 studies involving 937 participants were pooled. The analysis showed:
The pooled estimate did not attain statistical significance, and the low I2 indicated minimal between-study heterogeneity. The wide confidence interval, however, reflected uncertainty around the magnitude and direction of the effect.
What about specific safety outcomes?
No serious renal or hepatic adverse events (AEs) were reported in the included evidence. Comparative assessment of gastrointestinal and bleeding events was restricted by the availability and consistency of reported data. Follow-up periods also differed substantially between studies, ranging from single-dose exposure to 12 months.
How was the evidence assessed?
Investigators searched PubMed, Scopus, and Web of Science from database inception through May 2026 for randomized controlled trials (RCTs) reporting safety outcomes. Studies involving patients aged 0–18 years were found eligible, while adult or mixed-age studies were considered when pediatric-relevant safety data could be extracted. The review followed PRISMA 2020 recommendations.
What does this mean for practice?
The findings did not provide sufficient evidence to favor one analgesic solely on the basis of overall adverse-event risk. Clinical selection was guided by age, comorbidities, contraindications, and the specific acute pain setting, alongside the known safety considerations of each medicine. The limited certainty also highlighted the need for larger trials using consistent definitions and standardized adverse-event reporting.
The Clinical Takeaway
Current evidence did not demonstrate a significant overall safety difference between ibuprofen and acetaminophen for acute pediatric pain. Treatment decisions remained individualized, with age, comorbidities, contraindications, and the clinical setting considered when selecting an analgesic.
British Journal of Clinical Pharmacology
Ibuprofen vs. acetaminophen for acute mild-to-moderate pain management: A systematic review and meta-analysis of safety with a focus on paediatric populations
Gian Luigi Marseglia et al.
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