Rapid review finds no clear link between autism and paracetamol in pregnancy

Seven of the nine reviews concerning maternal paracetamol use during pregnancy warned against inferring a causal link, researchers found.
A pregnant woman takes a tablet with a glass of water

An evidence review has found no clear link between paracetamol use in pregnancy and autism or attention deficit hyperactivity disorder (ADHD) in children.

In their rapid umbrella review published in the BMJ on 10 November 2025, researchers analysed nine reviews around maternal paracetamol use during pregnancy, which together included 40 studies — 6 of which focused on autism and 17 on ADHD.

The authors of the rapid review said that the reviews they considered had “reported a possible-to-strong association between maternal paracetamol intake and autism or ADHD or both in offspring”.

However, after analysing the studies within the review, the authors said: “Our confidence in the review findings is low to critically low.”

Although the reviews reported some positive association between paracetamol use in pregnancy and adverse neurodevelopmental outcomes in children, the authors revealed that seven of the nine reviews warned against inferring a causal link, citing a “lack of data, bias in the primary studies and unmeasured or inadequately controlled confounders”.

The link between exposure to paracetamol and risk of autism and ADHD in childhood “disappeared or attenuated” when the data were adjusted to allow for familial factors through a sibling-controlled design and other confounders, the authors said.

The authors also found that the disappearance of association in sibling controlled-analyses suggest “shared family factors, such as parental mental health, genetic predisposition and socio-environmental background, explain much of the observed risk”.

Stakeholders, including regulatory bodies, clinicians, pregnant women and people affected by autism and ADHD, “should be informed about the poor quality of the existing reviews, and the likelihood that positive associations reported in studies were driven by familial confounding”, the authors concluded.

“Lack of evidence around medicine use during pregnancy remains a critical and long-standing problem, resulting from the historical and ongoing underinvestment in women’s health research,” the authors warned.

In a news story published alongside the review on 10 November 2025, the BMJ said that the review was fast-tracked for publication following comments by US president Donald Trump in September 2025, in which he claimed that there was a causal link between paracetamol use in pregnancy and an increased risk of autism in children.

Commenting on the rapid review, Grainne McAlonan, professor of translational neuroscience at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London, said: “This paper is welcome and careful assessment which rightly concludes the evidence does not clearly link use of paracetamol in pregnancy with autism of ADHD in the offspring.”

Dimitrios Siassakos, professor in obstetrics and gynaecology at University College London, commented: “The high-quality methodology used in this new umbrella review confirms what experts around the globe have been saying.

“The evidence that links paracetamol use in pregnancy to autism is tenuous and those studies which do report an association are confounded by the association of autism or ADHD with factors shared by families such as genetics, lifestyle etc.”

Claire Anderson, president of the Royal Pharmaceutical Society, commented: “Paracetamol has been safely used by millions when taken as directed, including during pregnancy; and this new BMJ review provides further reassurance.

“Expectant parents can be confident that paracetamol remains the first-line choice for pain or fever in pregnancy. Anyone with concerns should seek sound advice from a pharmacist or other trusted healthcare professional.”

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Citation
The Pharmaceutical Journal, PJ November 2025, Vol 315, No 8003;315(8003)::DOI:10.1211/PJ.2025.1.384785

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