Researchers from City St George’s University in London conducted the most extensive systematic review and meta-analysis to date of the scientific evidence relating to the use of paracetamol during pregnancy.
This review was prompted by claims that emerged in September 2025 alleging that paracetamol use during pregnancy could affect children's neurodevelopment and increase their risk of autism. These claims were based on studies that found limited associations but suffered from methodological biases, including poor data quality and the failure to compare siblings to account for genetic factors and family history.
To verify these claims, the researchers analyzed data from 43 high-quality studies, comparing pregnancies in which mothers took paracetamol with those in which they did not, focusing on studies that used more rigorous research designs.
The analysis also included sibling studies, in which children born to the same mother in different pregnancies were compared, with one child exposed to paracetamol while the other was not. This type of study allows for the control of shared genetic factors, family environment, and long-term parental characteristics, which are difficult to control in traditional studies.
The data for these comparisons included 262,852 children who underwent an assessment for autism diagnosis, 335,255 children for attention deficit hyperactivity disorder diagnosis, and 406,681 children for intellectual disability diagnosis.
The results clearly showed no association between taking paracetamol during pregnancy and the diagnosis of these disorders in children, compared to pregnancies in which the drug was not used.
Professor Asma Khalil, professor of obstetrics and maternal-fetal medicine at City St George’s University London and lead author of the study, said the findings suggest that previously reported associations “are more likely due to genetic predisposition or maternal health factors, such as fever or underlying pain, rather than a direct effect of paracetamol itself.”
She added that "the message is clear; paracetamol remains a safe option during pregnancy when used according to medical guidelines," stressing the importance of this given that it is the recommended first-line treatment for pain relief or fever reduction in pregnant women.
All included studies underwent quality assessment using the QUIPS tool, which specializes in monitoring the risks of bias. No association was recorded between the use of paracetamol and these disorders in studies classified as low-biased, or in studies whose follow-up period exceeded five years.
The researchers noted that one of the limitations of the study was the lack of sufficient data to analyze some sub-factors, such as the timing of paracetamol intake during pregnancy, the sex of the baby, or the number of times the drug was used.
Overall, the study's findings support the recommendations issued by major global medical bodies, and researchers hope they will help put an end to the anxiety associated with the use of paracetamol during pregnancy, especially since avoiding its treatment for severe pain or fever may expose the mother and fetus to known health risks, most notably untreated high maternal fever.
The results were published in the journal "The Lancet Gynecology, Obstetrics & Women's Health".
