Paracetamol and ibuprofen safe in first year of life, reports research

Dalziel says paracetamol and ibuprofen are the most common medicines prescribed or bought over the counter for babies worldwide.

“These results give parents and health professionals high confidence to continue to use these important medications.”

Almost 4,000 babies across New Zealand participated from birth, with half randomised to ensure their parents provided paracetamol and half to ensure their parents provided ibuprofen when the infants required medication for fever or pain relief in the first year of life.

The researchers asked parents at regular intervals whether their children had eczema or asthma symptoms, or bronchiolitis. They also checked prescribing and hospital records.

The results for the first year of data have now been analysed and published in the leading journal The Lancet Child & Adolescent Health.

Eczema affected about 16 percent of babies given paracetamol and 15 percent of those given ibuprofen. Bronchiolitis occurred in about five percent of babies in both groups. These differences were not significant. Serious side effects were rare, and none was caused by the medications.

The study found no association between either medication and eczema or bronchiolitis and confirmed that both drugs were safe to use.

It is the first randomised controlled trial – considered the gold standard for research – to address this question.

This paper is part of a longer project dubbed the ‘Paracetamol and Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki) study’.

PIPPA Tamariki is the largest trial ever conducted in children in New Zealand, and participants are being followed from birth to age six.

The researchers will soon publish findings on the same children at age three, and later at age six.

The long-term objective of the study is to test whether there are any links between paracetamol and specific conditions that can only be accurately diagnosed once children reach school age.

“We know that two‑thirds of children who are wheezy at age three years don’t develop asthma by age six,” says Dalziel.

“Thus we need to wait until school age to ultimately test if paracetamol in the first year of life causes asthma.”

Similarly, developmental disorders such as autism and attention deficit hyperactivity disorder (ADHD) are more accurately diagnosed as children get older.

Lead author Dr Eunicia Tan, a senior lecturer at the University of Auckland and emergency physician at Middlemore Hospital, says, “Ultimately, the study will provide important evidence regarding the link between paracetamol use and asthma, eczema, hay fever, and developmental disorders, such as autism and ADHD.”

Reference:

Tan, Eunicia et al., Paracetamol versus ibuprofen as required for fever or pain in the first year of life and the risk of eczema and bronchiolitis at age 1 year in New Zealand (PIPPA Tamariki): a multicentre, open-label, parallel-group, superiority, randomised controlled trial, The Lancet Child & Adolescent Health, DOI:10.1016/S2352-4642(25)00341-4