Landmark Trial: Baby Painkillers Paracetamol and Ibuprofen Are Equally Safe

A landmark randomized trial of nearly 4,000 babies found that acetaminophen (paracetamol) and ibuprofen are equally safe during the first year of life — with no increased risk of eczema or bronchiolitis. It is the first gold-standard trial to directly test long-held fears about the two most common baby pain relievers.

Key Takeaways

A landmark randomized trial of nearly 4,000 babies found that acetaminophen (paracetamol) and ibuprofen are equally safe during the first year of life — with no increased risk of eczema or bronchiolitis.
It is the first gold-standard trial to directly test long-held fears about the two most common baby pain relievers.

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A large randomized trial of nearly 4,000 New Zealand babies has delivered strong reassurance about two of the world's most-used infant medicines: paracetamol (acetaminophen) and ibuprofen are equally safe during the first year of life.

The study, part of the PIPPA Tamariki project and published in The Lancet Child & Adolescent Health, randomly assigned babies to receive either paracetamol or ibuprofen whenever they needed medicine for fever or pain during infancy. About 16 percent of babies in the paracetamol group developed eczema, compared with 15 percent in the ibuprofen group, and bronchiolitis affected about five percent of children in each group — differences that were not statistically significant. Serious side effects were uncommon, and none were attributed to either medicine.

Earlier observational studies had raised concerns that paracetamol given in infancy might be linked to eczema, asthma or other conditions later in childhood. The new trial is the first randomized controlled trial — the gold standard of medical evidence — to directly examine the question. 'Our study found that paracetamol and ibuprofen are incredibly safe to use in young children,' said lead researcher Professor Stuart Dalziel, Cure Kids Chair of Child Health Research at the University of Auckland and a pediatrician at Starship Children's Hospital. 'These results give parents and health professionals high confidence to continue to use these important medications.'

The findings come from the first year of a larger project that is the largest clinical trial ever carried out with children in New Zealand. Participants are being monitored from birth until age six, with results planned at ages three and six. The goal is to settle whether paracetamol use in the first year of life is connected to conditions that can only be reliably diagnosed later — including asthma, eczema, hay fever and developmental conditions such as autism and ADHD.

'We know that two-thirds of children who are wheezy at age three years don't develop asthma by age six,' said Dalziel. 'Thus we need to wait until school age to ultimately test if paracetamol in the first year of life causes asthma.' The research was funded by the Health Research Council of New Zealand and Cure Kids.