Prenatal paracetamol (acetaminophen) not linked to autism, ADHD, or intellectual disability

Taking paracetamol (acetaminophen) during pregnancy does not increase the risk of autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), or intellectual disability among children, according to a large systematic review and meta-analysis published January 16, 2026, in The Lancet Obstetrics, Gynaecology & Women’s Health.¹

The analysis was conducted in response to renewed public concern following claims in September 2025 that suggested paracetamol use during pregnancy might adversely affect child neurodevelopment and increase autism risk. According to the study authors, those concerns were driven by earlier observational studies that reported small associations but were limited by methodological weaknesses.

“Taking paracetamol during pregnancy does not increase the risk of autism, attention-deficit hyperactivity disorder (ADHD), or intellectual disability among children,” the researchers stated, describing their work as “the most rigorous analysis of the evidence to date.”

Study design and scope

Investigators conducted a systematic review and meta-analysis of 43 cohort studies examining prenatal paracetamol exposure and subsequent neurodevelopmental outcomes in children. Seventeen of these studies met criteria for inclusion in quantitative meta-analyses. Eligible studies were required to report adjusted risk estimates, define outcomes using validated questionnaires or medical records, and include information on maternal comorbidities and treatments. Studies reporting only unadjusted estimates were excluded.

The authors emphasized that the analysis was undertaken “to determine whether paracetamol was safe to use in pregnancy or not,” specifically in light of the public debate that followed claims suggesting an association with autism. As noted in the accompanying press release, “the claims were based on earlier studies that reported small associations between paracetamol in pregnancy and increased risks of autism. However, these were often based on studies prone to biases, including being limited by the type of data collected and not exploring comparisons between siblings to account for family history, which is vital information.”

Importance of sibling-comparison analyses

A defining feature of the study was its prioritization of sibling-comparison designs. These analyses compare siblings born to the same mother, where one pregnancy involved paracetamol exposure and another did not. This approach helps control for shared genetic, environmental, and long-term parental factors that conventional observational studies may not fully account for.

As described by the researchers, “this design helps control for shared genetics, family environment, and long-term parental characteristics that traditional studies cannot fully account for.”

Across the sibling-comparison studies included in the meta-analysis, data were available for 262,852 children assessed for autism spectrum disorder, 335,255 assessed for ADHD, and 406,681 assessed for intellectual disability. When compared with pregnancies with no paracetamol exposure, no association was identified between prenatal paracetamol use and any of these outcomes.

Key findings

In pooled analyses restricted to sibling-comparison studies, prenatal paracetamol exposure was not associated with autism spectrum disorder (odds ratio [OR], 0.98; 95% CI, 0.93–1.03), ADHD (OR, 0.95; 95% CI, 0.86–1.05), or intellectual disability (OR, 0.93; 95% CI, 0.69–1.24). The absence of an association persisted in analyses limited to studies judged to be at low risk of bias using the Quality In Prognosis Studies (QUIPS) tool and in studies with follow-up periods longer than 5 years.

Professor Asma Khalil, PhD, professor of obstetrics and maternal fetal medicine at City St George’s, University of London, and lead author of the study, said the findings help explain why earlier associations were observed. “Our findings suggest that previously reported links are likely to be explained by genetic predisposition or other maternal factors such as fever or underlying pain, rather than a direct effect of the paracetamol itself,” she said.²

She added, “The message is clear – paracetamol remains a safe option during pregnancy when taken as guided. This is important as paracetamol is the first-line medication we recommend for pregnant women in pain or with a fever, and so they should feel reassured that they still have a safe option to relieve them of their symptoms.”²

Study strengths and limitations

All included studies were assessed for quality using the QUIPS tool, which evaluates multiple domains of bias, including exposure measurement, confounding, outcome assessment, and statistical analysis. The lack of association between prenatal paracetamol exposure and neurodevelopmental outcomes remained consistent in studies deemed to be at low risk of bias and in those with longer follow-up durations.

The authors noted several limitations. In particular, it was not possible to conduct detailed subgroup analyses within sibling-comparison studies based on trimester of exposure, sex of the child, or frequency of paracetamol use because too few studies reported these data. Additionally, many studies relied on maternal self-reports of paracetamol use, which may be subject to recall bias.

Clinical implications

Despite these limitations, the authors concluded that the findings support current recommendations from major medical organizations worldwide regarding paracetamol use during pregnancy. They emphasized that avoiding paracetamol for significant pain or fever could expose both mother and fetus to known risks, particularly untreated maternal fever.

Overall, the researchers expressed hope that this “gold-standard review” would help address ongoing uncertainty and reassure clinicians and pregnant patients that paracetamol remains an appropriate first-line option for pain and fever management during pregnancy when used as directed.

References

1. D’Antonio F, Flacco ME, Valle LD, et al. Prenatal paracetamol exposure and child neurodevelopment: a systematic review and meta-analysis. The Lancet Obstetrics, Gynaecology, & Women’s Health. Published online January 2026. doi:https://doi.org/10.1016/s3050-5038(25)00211-0
2. City St George’s, University of London. Taking paracetamol during pregnancy does not increase risk of autism, ADHD or intellectual disabilities. Eurekalert. January 16, 2026. Accessed January 20, 2026. https://www.eurekalert.org/news-releases/1112802