Paracetamol in Pregnancy: New Study Debunks Neurodevelopmental Disorder Links

Paracetamol use during pregnancy does not increase the risk of autism, attention-deficit/hyperactivity disorder (ADHD) or intellectual disability in children, according to a new gold-standard evidence review published in The Lancet Obstetrics, Gynaecology, & Women’s Health. The systematic review and meta-analysis assessed 43 studies, which were deemed the largest and most methodologically rigorous, including those with sibling comparisons, providing strong evidence that paracetamol during pregnancy does not cause these neurodevelopmental disorders. This comes following public concerns raised in September 2025, when the US administration suggested a possible link between paracetamol use in pregnancy and autism. The authors say 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. Here, Australian experts weigh in on the latest research. ‘Fever during pregnancy is a risk for autism and poor pregnancy outcomes generally’ “Pregnant women have been concerned following the Donald Trump administration linking paracetamol consumption during pregnancy to autism,” says Dr Ian Musgrave, Senior Lecturer in the Faculty of Medicine, School of Medicine Sciences, within the Discipline of Pharmacology at the University of Adelaide. “However, there is strong evidence that paracetamol is not associated with autism, a large population-based sample of 2,480,797 children born in 1995 to 2019 in Sweden showed that paracetamol use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analysis (when exposed siblings were compared to unexposed siblings). “Similar large-scale sibling control studies in Japan published in 2025 have also shown no association with autism. This latest study should put any worries to rest. “This current study is a systematic review of 43 research studies and a meta-analysis of 17 research studies with comparable quantitative analysis. “A meta-analysis is a powerful statistical tool that combines the quantitative results from multiple independent studies to provide more sensitive detection of effects that may be missed in a single study. “This study, the largest of its kind for paracetamol use in pregnancy, found there was no association between paracetamol intake during pregnancy and autism spectrum disorder, ADHD, or intellectual disability. “Importantly, fever during pregnancy is a risk for autism and poor pregnancy outcomes generally. “This means that pregnant individuals can use paracetamol, one of the few agents available to women during pregnancy, as directed without fear of impacts on their unborn child.” ‘Avoiding effective treatment for fever or significant pain during pregnancy can carry real risks’ “This systematic review and meta-analysis provides some of the strongest evidence to date that paracetamol use during pregnancy is not associated with an increased risk of autism, ADHD, or intellectual disability in children,” says Dr Rudrarup Bhattacharjee, a Postdoctoral Researcher from The University of Adelaide. “Importantly, the authors prioritised high-quality study designs, particularly sibling-comparison analyses, which are among the best available methods for accounting for shared genetic and family-level factors that can otherwise bias results. “Their rigorous analyses showed no meaningful effect or association. This is a significant finding because earlier concerns were largely driven by conventional observational studies that could not fully separate the effects of paracetamol from the underlying reasons it was taken — for example, maternal fever, pain, or infection — factors that can themselves influence pregnancy and childbirth outcomes. “By carefully addressing these sources of bias, the study clarifies that previously reported links are unlikely to be causal. “In an Australian context, the findings are reassuring. “Paracetamol remains the recommended first-line option for managing pain and fever during pregnancy, and this evidence supports existing clinical guidance. “Avoiding effective treatment for fever or significant pain during pregnancy can carry real risks for both the mother and the developing fetus. “Overall, this study reinforces the importance of relying on high-quality evidence rather than speculation or politicised claims when making health decisions in pregnancy.” ‘The research must not be misinterpreted’ “This is timely and important research because it shows once again that paracetamol use in pregnancy is not associated with an increased likelihood of autism, ADHD, or intellectual disability,” says Professor David Trembath, Head of Autism Research at CliniKids at The Kids Research Institute Australia. “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. “The researchers analysed data from 43 previous studies, involving more than 2 million children, to look for possible associations between paracetamol use in pregnancy and neurodevelopment diagnoses. “This included re-analysing data from sibling studies, in which one child was exposed to paracetamol in pregnancy and the other child was not. No matter which way the researchers looked at the data, the answer came back the same — there was no association. “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.” ‘Vital that the public and the medical community are adequately informed’ “This is an extremely important study about paracetamol, a widely used and recommended analgesic medication for pregnant women,” says Professor Helen Leonard, Principal Research Fellow at The Kids Research Institute Australia and a Professor at UWA Medical School. “Recent suggestions in the media that its use in pregnancy was associated with autism and other neurodevelopmental disorders in the offspring may well have no credible scientific basis. “This study examined evidence for and against by undertaking a rigorous systematic review investigating the relationship between paracetamol exposure in pregnancy and the occurrence of autism, intellectual disability and attention deficit hyperactivity disorder in the offspring. “Restricting analyses to longitudinal studies with minimal bias and, by also including sibling comparison studies, which automatically adjust for family, genetic and environmental factors, the authors found no evidence of increased risk. “They particularly expressed concern that “the politicisation of scientific uncertainty could create confusion among pregnant women and clinicians”. “Given the widespread use of this medication in Australia and the recommendations for its use in pregnancy by professional and regulatory bodies, it is vital that the public and the medical community are adequately informed. “Otherwise, there is a danger that the avoidance of use of this medication in scenarios where it would be medically recommended could result in other adverse outcomes for the mother, pregnancy and the unborn baby.” ‘Reassuring to be able to offer pregnant women a well-established and studied safe pain reliever’ “Recent reports of paracetamol exposure during pregnancy causing ADHD and autism have been promoted by high-profile political figures in the United States, particularly, and contributed to the ongoing unnecessary stress placed on pregnant women,” says Gino Pecoraro OAM, Associate Professor of Obstetrics and Gynaecology at the University of Queensland and President of the National Association of Specialist Obstetricians and Gynaecologists (NASOG). “It is very reassuring that this study, the first systematic review and meta-analysis prioritising sibling comparison — in an effort to minimise bias and exclude confounding factors such as parental genetics, home environment and socio-economic status — does not support an association between paracetamol use and these childhood conditions. “It has, rather, found there is absolutely no increased risk to the children of women who took paracetamol during the pregnancy, specifically looking at the outcomes of autism spectrum disorder, ADHD and intellectual disabilities. “The relief of pain is one of the core duties of any medical practitioner, and pregnant women have a decreased number of options available to them. “It is timely and reassuring for us to be able to offer pregnant women a well-established and studied safe pain reliever to be used during pregnancy.”