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Tylenol Safe For Babies, Clinical Trial Finds
  • Posted January 30, 2026

Tylenol Safe For Babies, Clinical Trial Finds

Both acetaminophen and ibuprofen are safe for babies during the first year of life, a groundbreaking study has found.

Researchers found no link between using these over-the-counter painkillers and health problems like eczema or lung ailments, researchers reported Jan. 27 in The Lancet Child & Adolescent Health.

“Our study found that paracetamol and ibuprofen are incredibly safe to use in young children,” senior researcher Stuart Dalziel said in a news release. He’s the Cure Kids Chair of Child Health Research at the University of Auckland in New Zealand.

Acetaminophen (Tylenol) and ibuprofen (Advil) are the most common medicines prescribed or purchased over-the-counter for children worldwide, he said. (Paracetamol is the name used in some countries overseas for acetaminophen.)

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

For the study, researchers recruited nearly 4,000 babies across New Zealand. Half were randomly assigned to get acetaminophen and the other half ibuprofen whenever they needed medication for fever or pain.

Results showed that eczema affected about 16% of babies given acetaminophen and 15% given ibuprofen. Bronchiolitis, wheeze or asthma occurred in about 5% of babies from both groups.

Serious side effects were rare, and none were caused by the medications, researchers said.

Researchers will continue to track these children through to age 6, to see if they develop any other health problems allegedly caused by acetaminophen or ibuprofen.

“We know that two‑thirds of children who are wheezy at age 3 years don’t develop asthma by age 6,” Dalziel said. “Thus we need to wait until school age to ultimately test if paracetamol in the first year of life causes asthma.”

This follow-up also will track children’s rates of autism and ADHD, which are more accurately diagnosed as kids get older.

President Donald Trump has said parents shouldn’t give babies or children Tylenol for “virtually any reason,” based on unproven claims that it increases risk of autism.

Researchers hope this study – the first clinical trial to address the question – will eventually clear up any health concerns regarding acetaminophen.

“Ultimately, the study will provide important evidence regarding the link between (acetaminophen) use and asthma, eczema, hay fever and developmental disorders, such as autism and ADHD,” lead researcher Dr. Eunicia Tan, a senior lecturer at the University of Auckland, said in a news release.

More information

Anne & Robert H. Lurie Children’s Hospital of Chicago has more on acetaminophen and children.

SOURCE: University of Auckland, news release, Jan. 27, 2026

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