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There is “no evidence” that paracetamol use during pregnancy increases the risk of autism, attention deficit hyperactivity disorder (ADHD) or intellectual disability among children, according to results of a review and meta-analysis.
Publishing their findings in The Lancet Obstetrics, Gynaecology, & Women’s Health on 16 January 2026, researchers conducted a review of 43 studies, following an announcement in September 2025 by the Trump administration that taking paracetamol during pregnancy might increase the risk of autism among children.
The study authors said: “Earlier meta-analyses suggested small associations between paracetamol in pregnancy and increased risks of autism and ADHD, but these were often based on studies prone to biases.”
The largest and most methodologically rigorous studies — such as those with sibling comparisons — provide “strong evidence that paracetamol during pregnancy does not cause autism, ADHD or intellectual disabilities”, the authors added.
The researchers searched MEDLINE, Embase, ClinicalTrials.gov and the Cochrane Library from inception to 30 September 2025 for cohort studies, which reported adjusted estimates of the risk of autism spectrum disorder, ADHD and intellectual disability.
Eligible studies analysed by the researchers validated questionnaires or medical records to define outcomes, reported maternal comorbidities and treatments, as well as compared pregnancies with and without paracetamol exposure.
According to the results of the review, 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).
With the use of the Quality in Prognosis Studies tool, the researchers also found that there was 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.
This absence of association persisted when considering all studies with adjusted estimates and those with more than five years of follow up, the researchers noted.
The authors also said that the findings from the sibling comparisons and their pooled results from multiple studies suggest that previously reported associations between paracetamol during pregnancy and autism, ADHD or intellectual disabilities “may be due to other maternal factors, such as underlying pain, discomfort, fever, or genetic predisposition, rather than any direct effect from the paracetamol”.
“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 authors concluded.
Commenting on the study, Hannah Blencowe, maternal, perinatal and child health researcher at the London School of Hygiene and Tropical Medicine, said: “Pregnant women tend to overestimate the risk of medication-related harms, and might be especially susceptible to misinformation.”
“Balanced, empathetic risk messaging regarding potential exposures during pregnancy that presents existing empirical evidence while acknowledging uncertainties and countering misinformation is essential,” she added.
“Discouraging paracetamol use can induce unnecessary anxiety and might lead to inadequate management of maternal pain or fever or the use of alternative medications known to be unsafe in pregnancy.”
In a statement on the study, published on 17 January 2026, Alison Cave, chief safety officer at the Medicines and Healthcare products Regulatory Agency, said: “Paracetamol remains safe to use during pregnancy. This large-scale analysis of the evidence found no link between taking paracetamol during pregnancy and autism, ADHD, or disability in children.
“Paracetamol has been used for many years and is the recommended first choice for treating pain or fever during pregnancy. When taken as directed, it is safe and effective.
“As with all medicines, pregnant women should speak to their doctor, pharmacist or midwife if they have any questions, and follow the guidance provided with the medicine.”
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Yes, “when taken as directed [during pregnancy], [paracetamol] is [probably] safe and effective.” The problem is that it is almost certainly not being taken at the lowest effective dose for the shortest possible time and only when really needed. Paracetamol is, after all, a pain-killer that can be bought in any supermarket, petrol station, newsagent, etc, so is widely assumed to be safe for frequent or casual use. And that is why it is notoriously difficult to obtain accurate information on the actual level of exposure of the foetus to paracetamol when relying on self-reporting by the mother by means of a questionnaire. No-one has yet carried out the one single definitive study to finally settle this matter where paracetamol level in blood is checked on a daily basis throughout pregnancy. It really does not matter how sophisticated the statistical analysis of the dozens of studies in this field has been. If the actual level (AND timing) of exposure of the foetus to paracetamol is not known precisely, it has to be assumed that the level of exposure is under-estimated. Critical windows for developmental toxicity (for example, specific weeks for brain or gonadal development) may last only a few days, but typical cohorts in those dozens of studies classify exposure by trimester or “ever vs never,” which cannot resolve actual foetal dose in those windows [see https://doi.org/10.1093/aje/kwy193 ]. This under-estimated exposure of the foetus to paracetamol is a good candidate for the “residual confounding” from an “environmental” factor that is proposed as an alternative cause of autistic spectrum disorders.