A new umbrella review led by the University of Liverpool finds that current studies provide only low-to-critically low evidence linking maternal use of paracetamol in pregnancy to autism spectrum disorder or ADHD in offspring
According to a comprehensive review published by the BMJ on 10 November 2025, there is no clear and reliable link between paracetamol use during pregnancy and the development of autism or ADHD in children. Reflecting on nine systematic reviews that encompassed 40 observational studies, researchers from the University of Liverpool found that the confidence in existing evidence was low or critically low. They noted that once familial genetic and environmental factors were taken into account, the apparent associations largely disappeared.
Safety concerns for paracetamol in pregnancy
Recent announcements around the safety of using paracetamol in pregnancy sparked widespread concern; however, in direct response to this, researchers from the University of Liverpool conducted an in-depth evidence review of paracetamol use in pregnancy.
Regulatory bodies, clinicians, pregnant women, parents, and those affected by autism and ADHD should be informed about the poor quality of the existing reviews and women should be advised to take paracetamol when needed to treat pain and fever in pregnancy, they add.
Study lead Professor Shakila Thangaratinam from the University of Liverpool said: “Through this work, we have shown that based on current evidence, there is no clear link between women taking paracetamol during pregnancy and a diagnosis of autism or ADHD in their children. The findings should help healthcare professionals give evidence-based advice to women, and reassure mothers about the use of paracetamol during pregnancy if indicated.”
Analysing over 40 observational reviews of paracetamol in pregnancy
Existing systematic reviews on paracetamol use vary in quality, and studies do not adjust for essential factors shared by families or parents’ health and lifestyle, which prevents the accurate estimation of the effects of exposure to paracetamol before birth on neurodevelopment in babies.
To address this, researchers carried out a high-level evidence summary of systematic reviews to assess the overall quality and validity of existing evidence and the strength of association between paracetamol use during pregnancy and autism or ADHD in babies.
They identified nine systematic reviews that included a total of 40 observational studies reporting on paracetamol use in pregnancy and the risk of autism, ADHD, or other neurodevelopmental outcomes in exposed offspring. Four reviews included meta-analysis, which combines data from multiple studies to give a single, more precise estimate.
The researchers carefully assessed each review for bias and rated their overall confidence in the findings as high, moderate, low, or critically low.
All reviews associated a mother’s paracetamol intake with autism or ADHD, or both in offspring. However, seven of the nine reviews advised caution when interpreting the findings due to the potential risk of bias and the impact of unmeasured factors in the studies. Overall, the researchers’ confidence was low (in two reviews) to critically low (in seven reviews).
The researchers found only one review, which included two studies, appropriately adjusted for possible side effects of genetic and environmental factors shared by siblings, and accounted for factors such as parents’ mental health, background and lifestyle.
In both these studies, the observed association between exposure to paracetamol and risk of autism and ADHD in childhood disappeared or reduced after adjustment, suggesting that these factors explain much of the observed risk, say the researchers.
There were some limitations, such as differing scope and methods, as well as the effects of timing and dose; their analysis was limited to autism and ADHD outcomes only.
Professor Louise Kenny, Pro-Vice-Chancellor and Head of the Faculty of Health and Life Sciences, University of Liverpool, said: “Current evidence does not demonstrate a clear link between paracetamol use in pregnancy and autism, but our work also demonstrates how poor the data is around medications in pregnancy. This highlights the wider problem of historic and continuing underinvestment in women’s health research.”
