Taking paracetamol while pregnant is safe and there is no evidence it increases the risk of autism, ADHD and developmental issues in children, say experts behind a major new review, published in The Lancet.
After analysing 43 studies, they wrote that pregnant women “should feel reassured” by the findings – which contradict controversial claims from US President Donald Trump last year that paracetamol “is no good” and pregnant women should “fight like hell” not to take it, reports the BBC.
Medical organisations worldwide had criticised Trump’s views at the time, and experts say this latest, rigorous review, should end the debate over paracetamol’s safety once and for all.
The appraisal of dozens of previous studies on the subject constitutes “the most rigorous analysis of the evidence to date”, the researchers say. Papers they examined that compared health outcomes among children born to the same mother included 262 852 under-18s who had been assessed for autism, 335 255 assessed for ADHD and 406 681 assessed for intellectual disability.
Published in The Lancet Obstetrics, Gynaecology & Women's Health, it was undertaken by a team of seven researchers from across Europe, led by Asma Khalil, a Professor of Obstetrics and Maternal Foetal Medicine at City St George’s, University of London, who is also a consultant obstetrician at St George’s Hospital in London.
It looked at 43 of the most robust studies into paracetamol use during pregnancy, involving hundreds of thousands of women, particularly those comparing pregnancies where the mother had taken the drug to pregnancies where she hadn’t.
The researchers say using these high-quality studies of siblings means they can dismiss other factors such as different genes and family environments, which makes their review “gold-standard”.
The research also looked at studies with a low risk of bias and those that followed children for more than five years to check for any link.
“We found no links, there was no association, there’s no evidence that paracetamol increases the risk of autism,” lead study author Khalil told the BBC.
“The message is clear – paracetamol remains a safe option during pregnancy when taken as guided,” she added.
This reinforces guidance from major medical organisations in the UK, US and Europe on the safety of the common painkiller, including the American College of Obstetricians and Gynaecologists, which had all quickly disputed Trump’s statements at the time.
They had argued that doctors already advised their pregnant patients to use the medication judiciously, and cautioned that untreated fevers during pregnancy could cause health problems for the mother and the baby, according to The New York Times.
Because paracetamol passes into the brain and also crosses the placenta during pregnancy, scientists have been researching its possible effects on foetal brain development for more than a decade.
However, it has been difficult to draw firm conclusions, in part because of limitations on how scientists can study the question. No randomised, controlled clinical trials have been conducted, because of ethical issues regarding research on pregnant women.
Another barrier is just how ubiquitous paracetamol is. Other painkillers are known to cause serious harms during pregnancy, so it has long been recommended as the first-line treatment. And because it is available over the counter, it is difficult for scientists to track how much women are using it and when.
Other factors
The Lancet review says that any previously-reported links between the drug and an increased risk of autism are likely to be explained by other factors, rather than a direct effect of the paracetamol itself.
"This is important as paracetamol is the first-line medication we recommend for pregnant women in pain or with a fever,” emphasised Khalil.
Medical experts not involved in the research have welcomed the study’s findings, saying it will help reduce worry among women.
Prof Grainne McAlonnan, from King’s College London, said expectant mothers “do not need the stress of questioning whether medicine most commonly used for a headache could have far-reaching effects on their child's health”.
“I hope the findings of this study bring the matter to a close,” she said.
Profssor Ian Douglas, from the London School of Hygiene and Tropical Medicine, said the review was “well-conducted” because it excluded studies of lower quality, where no account was taken of important differences between mothers who use or don’t use paracetamol during pregnancy, such as underlying illnesses.
Professor Jan Haavik, molecular neuroscientist and clinical psychiatrist at the University of Bergen, said the study provides “strong evidence” that use of paracetamol during pregnancy does not increase the risk of autism, ADHD or intellectual disability and “should effectively put this question to rest”.
A spokesman from the US Department of Health and Human Services said “many experts” had expressed concern over the use of acetaminophen – the US name for paracetamol – during pregnancy.
For example, it said, a review in August 2025 led by Dr Andrew Baccarelli, Dean of the Harvard TH Chan School of Public Health, found that using acetaminophen during pregnancy may increase children’s autism and ADHD risk, and urged caution over “especially heavy or prolonged use”.
But some of the studies included in that review did not account for underlying factors that might be driving the connection, Khalil said.
For instance, women typically take paracetamol because of health issues during their pregnancies, including infections and fevers, and those health problems themselves can increase the risk of neurodevelopmental disorders.
The new review excluded any studies that did not account for such possible confounding factors. And it gave more weight to studies that tried to account for the role of genetics, comparing siblings born to the same mother. Genetics is known to be a major contributor to autism risk.
“These were all attempts, really, to derive the evidence from the good-quality studies,” Khalil said. The sibling studies were the most rigorously designed, she said, because they take into account shared genetic factors and shared family environment.
Experts praised the new review for helping to better examine the different types of studies that had been done to date. But some also cautioned that questions still remained unanswered: it did not, for example, consider how frequently pregnant women used acetaminophen, or at what doses.
Eivind Ystrom, a senior researcher at the Norwegian Institute of Public Health, said he supported the conclusion of the new review “given our current knowledge”. But, he added, “at the same time, we should do more and better studies”.
Ystrom conducted a study in 2021 suggesting that pregnant women who take acetaminophen for more than 29 days may be at higher risk of having children with ADHD.
Health officials in the UK have stressed that paracetamol remains the safest painkiller available to pregnant women.
Dr Steven Kapp, a senior lecturer in psychology at the University of Portsmouth, told The Guardian: “An implication is that society needs to stop going down rabbit holes of seeking false prevention of developmental disabilities. Instead, we should focus on making the world a better place for disabled people.”
Study details
Prenatal paracetamol exposure and child neurodevelopment: a systematic review and meta-analysis
Francesco D'Antonio, Maria Elena Flacco, Lorenza Della Valle, et al.
Published in The Lancet Obstetrics, Gynaecology & Women's Health on 16 January 2026
Summary
Background
Concerns have emerged about the impact of paracetamol use in pregnancy on child neurodevelopment, particularly in relation to autism spectrum disorder. We aimed to synthesise available evidence to investigate associations between prenatal paracetamol exposure and autism spectrum disorder, attention-deficit hyperactivity disorder (ADHD), and intellectual disability.
Methods
For this systematic review and meta-analysis, we searched MEDLINE, Embase, ClinicalTrials.gov, and the Cochrane Library from inception to Sept 30, 2025, for cohort studies reporting adjusted estimates of the risk of autism spectrum disorder, ADHD, and intellectual disability. Eligible studies used validated questionnaires or medical records to define outcomes, reported maternal comorbidities and treatments, and compared pregnancies with and without paracetamol exposure, whereas unadjusted studies were excluded. Quality assessment of the included studies was conducted using the Quality In Prognosis Studies (QUIPS) tool. The primary outcomes were the associations between prenatal paracetamol exposure and the likelihood of autism spectrum disorder, ADHD, and intellectual disability. Analyses were restricted to sibling-comparison studies with adjusted estimates, and odds ratios (OR) were calculated. Random-effects meta-analyses used the generic inverse variance method. Subgroup analyses were performed when possible (trimester, duration of use, offspring sex, and follow-up length).
Findings
43 studies were included in the systematic review, and 17 studies in the meta-analysis. When considering sibling comparison studies, paracetamol exposure during pregnancy was not associated with the risk of autism spectrum disorder (OR 0·98, 95% CI 0·93–1·03; p=0·45), ADHD (0·95, 0·86–1·05; p=0·31), or intellectual disability (0·93, 0·69–1·24; p=0·63). There was also no association between paracetamol intake during pregnancy and autism spectrum disorder (OR 1·03, 95% CI 0·86–1·23; p=0·78), ADHD (0·97, 0·89–1·05; p=0·49), or intellectual disability (1·11, 0·92–1·34; p=0·28) when considering only studies at low risk of bias according to QUIPS. This absence of association persisted when considering all studies with adjusted estimates and those with more than 5 years of follow-up.
Interpretation
Current evidence does not indicate a clinically important increase in the likelihood of autism spectrum disorder, ADHD, or intellectual disability in children of pregnant individuals who use paracetamol as directed, supporting existing recommendations on its safety.
The Guardian article – Study debunks Trump claim that paracetamol causes autism (Open access)
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