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A study published in The Lancet Obstetrics, Gynaecology, & Women’s Health looks at paracetamol use during pregnancy and the risk of autism, ADHD or intellectual disabilities.
Comments from our friends at the All Ireland Science Media Centre:
Dr Jeffrey Glennon, Assistant Professor at University College Dublin School of Medicine / Conway Institute, comments:
“ADHD and autism affects around 1% and 5% of people in Ireland. There were previous media reports that use of paracetamol (also known as acetaminophen) during pregnancy may constitute a risk factor for ADHD and autism. This is incorrect. A landmark systematic review from Italian, UK and Norwegian researchers published in The Lancet – Obstetrics, Gynecology and Women’s Health analysing 43 studies has concluded there is no association between paracetamol use by expectant mothers and ADHD, autism or intellectual disability in their offspring.
“Moreover this study also performed a meta-analysis aggregating 17 studies and reached the same conclusion. The degree of rigour and the approach taken accounting for any biases in any previous studies was commendable. This reinforces the findings from an earlier Swedish and American study that also demonstrated no link between paracetamol use by pregnant mothers and autism spectrum traits in their children. This study examined registry data for 2.4 million Swedish-born children between 1995 and 2019, analysing data from nearly 186,000 children whose mothers were treated with paracetamol during pregnancy. No evidence of a link between maternal paracetamol use and autistic traits was found. Taken together, the consensus amongst the biomedical community highlights that paracetamol use during pregnancy is safe and expectant mothers should not be concerned over its use affecting their risk of ADHD, autism or intellectual disability in their children.”
Dr Brian Clearly, Irish Medicines in Pregnancy Service & Pharmacy Executive Manager, Rotunda Hospital/ Honorary Clinical Professor-, RCSI, comments:
“This important systematic review and meta-analysis published in The Lancet Obstetrics, Gynaecology & Women’s Health finds no evidence that paracetamol use during pregnancy increases the risk of autism, ADHD, or intellectual disability in children.
“The authors followed a pre-specified, registered protocol and conducted a robust analysis of all relevant high-quality studies on this topic. In total, 43 studies were reviewed, and 17 were included in the combined meta-analysis.
“The analyses found no increased risk of neurodevelopmental disorders linked to prenatal paracetamol exposure. The results are strengthened by the fact that the authors looked at studies with the most rigorous study design (large sibling-comparison cohorts) and those rated highest for methodological quality.
“This is a very important study as paracetamol is the most widely used medicine to treat pain and fever during pregnancy. This robust review provides reassurance for the public and health professionals: paracetamol remains a safe and effective option for managing pain and fever in pregnancy. Paracetamol is the medication of choice in pregnancy as it is not associated with the adverse effects that can happen with other medicines like ibuprofen or oxycodone. Avoiding paracetamol unnecessarily could lead to risks from untreated fever or severe pain leading to adverse pregnancy outcomes.
“The findings align with position statements from multiple medical organisations including the American College of Obstetricians & Gynecologists, the Royal College of Obstetricians & Gynaecologists, the European Network of Teratology Information Services and international medication regulators.
“This was an unfunded study and the authors reported no conflicts of interest, in contrast to some previous studies in this context where authors were involved in legal processes involving manufacturers of paracetamol.”
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Dr Amanda Roestorf, Director of Research at Autistica, said:
“This is a large, carefully conducted systematic review and meta-analysis, drawing on over 40 studies and giving greater weight to more robust designs such as sibling-comparison studies, which help control for shared genetic and environmental factors.
” These higher-quality studies consistently show no meaningful association between paracetamol use in pregnancy and autism or ADHD. As in all observational research, this evidence cannot prove the absolute absence of risk in every circumstance, but the consistency and methodological strength of the findings provide a high degree of confidence in the conclusions. Taken together with existing regulatory guidance, this supports current recommendations that paracetamol remains appropriate for treating fever during pregnancy.”
Dr Monique Botha, Associate Professor in Social and Developmental Psychology, Durham University, said:
“This is a strong and reliable study that addresses a question many people are understandably worried about given recent prominent politicisation of the topic.
“The researchers reviewed all the best available evidence about whether paracetamol increases the risk of ADHD, autism, or intellectual disability, and focused on the most robust studies, particularly those comparing siblings within the same family. These studies are important because they rule out alternative explanations such as genetics, family environment, or the underlying illness that led someone to take paracetamol in the first place.
“When this higher-quality evidence is examined, the findings are clear: there is no evidence that using paracetamol as recommended during pregnancy increases the risk of autism, ADHD, or intellectual disability. The authors use rigorous methods. They pre-registered the review process (inclusion and exclusion criteria, analysis plan etc), assess study quality carefully using established protocols, and avoid misleading claims throughout. This is a welcome and robust addition to the literature.
“Overall, this is a well-conducted, trustworthy piece of research that provides clear reassurance and supports current medical advice on the safe use of paracetamol in pregnancy.”
Prof Ian Douglas, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine (LSHTM), said:
“The investigators have been thorough in their discussion of the limitations of the research and justifiably robust in their defense of the role paracetamol has as a treatment option when needed for pregnant women with pain or fever.
“After studies that are of lower quality and do not account for the important differences between mothers who use or don’t use paracetamol during pregnancy are excluded, reassuringly, the remaining studies do not suggest paracetamol use in pregnancy is associated with an increased risk of any of the neurodevelopmental conditions considered.
“This is a timely and well conducted systematic review, which gathers together and analyses all the previously conducted relevant studies designed to determine whether paracetamol use during pregnancy increases the risk of autism spectrum disorder, attention-deficit hyperactivity disorder (ADHD), and intellectual disability. The investigators made the decision to focus only on studies where either 1) comparisons were made between siblings whose mother had pregnancies with and without exposure to paracetamol; 2) the study was judged to have a low risk of bias; or 3) studies with at least 5 years of follow up. By doing this, they automatically excluded studies that were of lower quality and where no account was taken of important differences between mothers who use or don’t use paracetamol during pregnancy. Those studies typically observe an apparent harm associated with paracetamol, but which is almost certainly due to important differences between the women included, rather than being caused by paracetamol. By excluding these studies, the authors have reduced the unhelpful “noise” they tend to generate. “
Prof Jan Haavik, Molecular Neuroscientist and Clinical Psychiatrist, University of Bergen, said;
“This large meta-analysis provides updated risk estimates and elegantly summarizes current knowledge regarding prenatal exposure to paracetamol as a risk factor for neurodevelopmental disorders in the offspring. Some studies have indicated that paracetamol use is associated with an increased risk of these conditions. However, such studies are typically subject to confounding by indication and other sources of bias. Here the authors used strict inclusion criteria, where they only analyzed large studies with access to sibling comparison data. It is likely that this method provides more realistic risk estimates. Although no study design is perfect, or free from limitations, this study provides strong evidence that ordinary maternal use of paracetamol does not increase the risk of either ADHD, ASD or intellectual disability. The study by D’Antonio and coworkers should effectively put this question into rest. There are many potential genetic and environmental risk factors for neurodevelopmental disorders that also should be explored. This study shows how sibling design studies can be used to reduce bias in pharmacoepidemiologic studies.”
Dr Steven Kapp, Senior Lecturer in Psychology, University of Portsmouth, said:
“The evidence supports the conclusion by D’Antonio and colleagues that Tylenol/paracetamol does not cause autism, ADHD, nor intellectual disability. Its scientific rigour included accounting for cofounders such as having a sibling with the condition, as these neurodivergences run in families. Parents of disabled children might be more likely to take paracetamol because of pains related to parenting stress or their own chronic conditions (which neurodivergent parents are more likely to have). The sibling control in these studies shows that the medication does not cause their child’s disability. As a neurodivergent researcher and advocate, I think an implication is that society needs to stop going down rabbit holes of seeking false prevention of developmental disabilities. Instead, we should focus more on making the world a better place for disabled people.”
Prof Grainne McAlonan, Professor of Translational Neuroscience, King’s College London (KCL), 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. This thorough and clear study approached the question by conducting both a substantial systematic review of the literature and a meta-analysis of eligible studies. Importantly, it prioritized sibling design studies to account for family history, which is crucial. This confirmed that there is no relationship between taking paracetamol in pregnancy and a higher likelihood of autism, ADHD or intellectual disabilities in the offspring. While the impact of last year’s announcement has been extensive, I hope the findings of this study bring the matter to a close.”
‘Prenatal paracetamol exposure and child neurodevelopment: a systematic review and meta-analysis’ by Francesco D’Antonio et al. was published in The Lancet Obstetrics, Gynaecology, & Women’s Health at 23:30 UK time on Friday the 16th January 2026.
DOI: https://doi.org/10.1016/S3050-5038(25)00211-0
Declared interests:
Dr Jeffrey Glennon: “No conflicts of interest”
Dr Brian Clearly: “None”
Dr Amanda Roestorf: “No DOIs to declare”
Dr Monique Botha: “I don’t have competing work in this specific field. I have never worked or been sponsored by a pharmaceutical company or related medical technology company. I used to be a board member for information autism which gives non-partisan information on autism treatments, supports, and interventions to family. I’ve never received money from a company to present my work at a conference. My previous work has been sponsored through a research fellowship by the Leverhulme research trust which is a charitable organisation. “
Prof Ian Douglas: “I have research grants from and shares in GSK”
Prof Jan Haavik: “Research funding: University of Bergen, Stiftelsen KGJebsen, Helse Vest, Haukeland University Hospital, Research council of Norway, NIH, ECNP, European Commission (FP7, H2020, Horizon Europe).”
Dr Steven Kapp: “I have no conflicts to declare.”
Prof Grainne McAlonan: “I run a large study which examines influences on prenatal brain development and later childhood outcomes funded by philanthropy”
This Roundup was accompanied by an SMC Briefing.