According to the World Health Organization, approximately one in 127 individuals worldwide had autism spectrum disorder (ASD) in 2021. ASD is theorised to be caused by a combination of genetic and environmental factors, including the use of certain medications during pregnancy. In September 2025, the US Government suggested that taking acetaminophen (also known as paracetamol) during pregnancy may contribute to ASD development in children. This suggestion was controversial as paracetamol is commonly used to alleviate pain and fever during pregnancy, with the National Health Service stating that it is the first choice of painkillers for pregnant individuals. As well as this, the quality of the review used to justify this suggestion has come under scrutiny, as it was limited by data variability, and the studies that were included in the review defined their exposure and outcome variables differently. In research published in January 2026 in The Lancet Obstetrics, Gynaecology, & Women’s Health, Francesco D’Antonio and colleagues conducted a meta-analysis study that measured the association between paracetamol exposure during pregnancy and ASD development to assess the validity of this suggestion. The study found that there was no statistically significant association between paracetamol exposure during pregnancy and ASD development.
To observe the effects of paracetamol exposure and the odds of children developing ASD, this study conducted a meta-analysis using electronic databases (MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov), covering studies published from the inception of the database to September 2025. Studies were included in the meta-analysis if they had a cohort design, information on paracetamol exposure among pregnant women (via assessment of biomarkers/medical records, or self-reported), an explicit definition of primary outcomes (and secondary outcomes if applicable) diagnosed using validated questionnaires/medical records, adjusted estimates comparing pregnancy outcomes in women who took paracetamol versus those who did not during pregnancy, and available information on comorbidities and treatments during or before pregnancy. From the selection process, eight studies were selected, with a joint sample size of 339,040 participants. No statistically significant association was found between paracetamol exposure during pregnancy and risk of ASD development. Additionally, meta-analyses of studies with sibling comparisons only, studies with a low risk of bias (according to Quality in Prognosis Studies criteria), and studies with a follow-up of more than five years all showed no statistically significant association between paracetamol exposure during pregnancy and risk of ASD development.
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This study by D’Antonio and colleagues provides evidence that paracetamol exposure during pregnancy has no influence on ASD development in children, indicating that paracetamol is safe to use during pregnancy. This is beneficial as paracetamol not only relieves pregnant individuals of pain, but it also prevents the adverse effects of a high fever and pain, which would affect fetal development.
GlobalData epidemiologists forecast that in the 16 major markets (16MM: US, France, Germany, Italy, Spain, UK, Japan, China, Australia, Brazil, Canada, India, Mexico, Russia, South Africa, and South Korea), diagnosed prevalent cases of ASD in men and women of all ages will decrease from 14.0 million cases in 2026 to 13.5 million cases in 2034.
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