TOPLINE: 

Paracetamol and ibuprofen used for fever or pain in infants during the first year of life showed no significant difference in the risk for eczema or bronchiolitis. Serious adverse events were rare and unrelated to the medications.

METHODOLOGY:

• Researchers conducted a two-arm, parallel-group, superiority randomized controlled trial at three sites in New Zealand to assess whether treatment with paracetamol vs ibuprofen increased the risk for eczema and bronchiolitis during the first year of life.
• A total of 3908 infants younger than 8 weeks (median age, 4 days; 49% girls) and born in New Zealand were randomly assigned to receive either paracetamol (n = 1985) or ibuprofen (n = 1923) for fever or pain until 1 year of age.
• Paracetamol was administered at 15 mg/kg every 6 hours for infants younger than 1 month and every 4 hours for those 1 month or older. Ibuprofen was given at 5 mg/kg every 6 hours for infants younger than 3 months and 10 mg/kg every 6 hours for those 3 months or older.
• Key outcomes were eczema and bronchiolitis, and the safety outcomes were hospitalizations for adverse reactions, death, and serious adverse events.
• Parents or caregivers provided information on infants' medication usage, any history of wheezing or breathing issues, hospital visits, and adverse reactions at 1, 3, 6, and 9 months and 1 year.

TAKEAWAY:

• Intervention crossover occurred, with at least one dose of nonintervention treatment (ibuprofen or paracetamol) received by 16.5% of infants in the paracetamol group and 41.3% of infants in the ibuprofen group.
• Eczema occurred in 16.2% of infants in the paracetamol group and 15.4% of infants in the ibuprofen group, with no significant between-group difference in risk (absolute risk difference, 0.8%; P = .48). Bronchiolitis was reported in 4.9% of infants in the paracetamol group and 4.3% of infants in the ibuprofen group, with no significant difference in risk.
• Infants in the paracetamol group were less likely to receive at least one prescription for eczema medication than those in the ibuprofen group (adjusted odds ratio, 0.85; P = .030).
• Serious adverse events were not attributed to the trial medications and occurred in 0.4% of infants in the paracetamol group and 0.5% in the ibuprofen group. Overall, 406 hospitalizations for adverse reactions were reported in the paracetamol group and 422 were reported in the ibuprofen group.

IN PRACTICE:

"These findings suggest that either paracetamol or ibuprofen can be used for treating pain or fever in infancy," the authors of the study wrote.

"Parents and prescribers will find reassurance that the choice of antipyretic or analgesic can be based on likely effectiveness rather than the risk of atopic disease at age 1 year," an expert wrote in an accompanying comment.

SOURCE:

The study was led by Eunicia Tan, MBChB, of the Department of Surgery at the University of Auckland in Auckland, New Zealand. It was published online on January 27, 2026, in The Lancet Child & Adolescent Health.

LIMITATIONS: 

The study could not mask trial medications due to differing dosages and intervals. The absence of a placebo group limited the ability to assess the independent effects of ibuprofen. Some participants received alternative interventions.

DISCLOSURES:

The study was supported by grants from the Health Research Council of New Zealand, Cure Kids New Zealand, and the University of Auckland. One author disclosed receiving research funding and consulting fees from and serving on advisory boards for AstraZeneca and Teva, and also reported serving as a member or chair for foundations.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.