A Lancet Gold-standard analysis finds no neurodevelopmental risk from paracetamol use in pregnancy.
A major new study published in The Lancet Obstetrics, Gynaecology & Women’s Health has provided more high-quality evidence that taking paracetamol during pregnancy does not increase the risk of autism spectrum disorder, attention-deficit hyperactivity disorder or intellectual disability in children.
The paper comes four months after US president Donald Trump’s controversial claim that taking paracetamol during pregnancy might increase the risk of autism among children.
Mr Trump’s Health and Human Services secretary Robert F. Kennedy Jr. also said the US Food and Drug Administration (FDA) planned to issue a physician advisory on potential risks of using the medication during pregnancy and initiated a safety label change on the medication.
Mr Trump said at the time he believed pregnant women should “strongly” limit the use of paracetamol.
“Pregnant women should talk to their doctors,” Mr Trump said. “Ideally, you don’t take it at all.”
Australian experts and peak bodies, including Australia’s FDA counterpart the Therapeutic Goods Administration (TGA), the Australian Medical Association and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, were quick to debunk the claims.
“Paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy,” the TGA said in a statement.
“The TGA has no current active safety investigations for paracetamol and autism, or paracetamol and neurodevelopmental disorders more broadly.”
The latest Lancet article synthesised data from 43 studies and included pooled analyses from 17 of them, emphasising rigorous designs such as sibling comparisons to control for shared genetic and environmental factors.
The researchers found that the largest and methodologically strongest studies showed no evidence of a causal link between paracetamol exposure in utero and later diagnoses of autism, ADHD or intellectual disability, and that previously observed associations likely reflected underlying maternal factors such as fever, pain or inflammation rather than a direct pharmacological effect.
The authors noted that untreated maternal fever and significant pain could carry known risks to both mother and foetus, reinforcing that paracetamol remained the first-line recommended analgesic and antipyretic in pregnancy when used as directed.
“Future studies should employ designs that minimise confounding by indication, such as sibling or other quasi-experimental approaches, and, where feasible, incorporate biomarker-based exposure assessment to improve the precision of exposure measurement and strengthen causal inference,” the researchers concluded.
“Maternal use of paracetamol during pregnancy does not seem to increase the likelihood of autism spectrum disorder, ADHD, or intellectual disability. This finding supports the recommendations made by major medical organisations regarding its use.”
Australian experts say the findings provide important reassurance for both clinicians and pregnant women, particularly after widespread public anxiety followed statements made in the US in September 2025 suggesting a possible link between paracetamol and autism based on limited observational data.
They also cautioned against the politicisation of scientific uncertainty, warning that selective interpretation of observational data can undermine evidence-based care. They argue that the latest review reinforced the importance of proportional risk–benefit assessment in obstetric practice, and that precautionary calls to avoid paracetamol are not justified by the current evidence.
Dr Anya Arthurs, a Future Making Fellow at University of Adelaide and the Robinson Research Institute, and a joint academic at Flinders University, said the study provided “some of the clearest and most reassuring evidence we have so far about paracetamol use in pregnancy”.
“The researchers looked carefully at the highest-quality data available, including studies that compared siblings within the same family. That approach is important because it helps separate the effects of a medication from family background, genetics, and shared environment,” she said.
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“They conclude that there is no meaningful increase in the risk of autism, ADHD, or intellectual disability in children whose mothers used paracetamol during pregnancy.
“This matters because paracetamol is often the safest and sometimes the only option to treat pain or fever during pregnancy. Fever itself can be harmful to both the mother and the developing baby, so avoiding treatment out of fear can actually do more harm than good.
“What this paper shows is that earlier alarm was likely driven by confusion between cause and coincidence. People who need paracetamol during pregnancy may already be dealing with illness, infection, or inflammation. Those factors, not the medication, are far more likely to influence child development.
“Using paracetamol as directed during pregnancy remains safe. This study helps bring the conversation back to evidence, balance, and common sense – and that reassurance is incredibly important for families making everyday health decisions.”
Associate Professor Alex Polyakov, a Clinical Associate Professor at the University of Melbourne and a medical director at Genea Fertility Melbourne, said paracetamol has had a central role in obstetric practice for decades “because it has consistently demonstrated the most favourable balance between maternal benefit and foetal safety for the management of pain and fever in pregnancy”.
“In this context, the comprehensive systematic review and meta-analysis by D’Antonio et al. provides a timely and methodologically rigorous reassurance,” he said.
“By prioritising sibling-comparison designs and studies at low risk of bias, the authors appropriately address the central challenge of confounding by indication, familial genetics, and shared environmental factors that have plagued earlier analyses.
“When these sources of bias are addressed, prenatal paracetamol exposure is not associated with an increased risk of autism spectrum disorder, attention-deficit hyperactivity disorder, or intellectual disability, with pooled estimates that are not only null but sufficiently precise to exclude clinically meaningful harm.
“This finding is critically important, as earlier signals of risk are far more plausibly explained by the underlying maternal conditions prompting paracetamol use, such as infection, fever, inflammation, or pain, all of which are themselves associated with adverse pregnancy and neurodevelopmental outcomes.
“The harms of untreated maternal fever and significant pain are well established, including increased risks of miscarriage, congenital anomalies, preterm birth, and adverse neurodevelopment.”
Professor Polyakov said precautionary calls to avoid paracetamol represented “a misapplication of the precautionary principle, divorced from proportionality and clinical reality”.
“Avoidance is not a neutral act; it risks exposing women and foetuses to known and preventable harms while offering no demonstrable benefit,” he said.
“From a practical obstetric perspective, the implications are clear and clinical advice remains unchanged. Paracetamol should remain the first-line analgesic and antipyretic in pregnancy, used at the lowest effective dose for the shortest necessary duration, as is appropriate for any medication in pregnancy.”
Professor David Trembath, head of Autism Research at CliniKids at The Kids Research Institute Australia, said this was both timely and important research because it showed once again that paracetamol use in pregnancy was not associated with an increased likelihood of autism, ADHD, or intellectual disability.
“Doctors and scientists have long held the view that paracetamol is safe, and that it can play an important role during pregnancy, including to reduce maternal feedback. The findings of the review support that position,” he said.
“These findings should help doctors when providing advice about the use of paracetamol during pregnancy.
“However, the research must not be misinterpreted. There is a risk that some people may read the findings as suggesting there is a goal to reduce the likelihood of autism, ADHD, or intellectual disability in children. To do so would be abhorrent and completely misaligned with contemporary thinking and community expectations.”
The Lancet Obstetrics, Gynaecology & Women’s Health, January 2026
