Asma Khalil, PhD, explains how prenatal paracetamol use does not increase developmental risks

Concerns about a possible link between paracetamol (acetaminophen) use during pregnancy and autism in children emerged in 2025, prompting anxiety among pregnant patients and renewed scrutiny of the existing evidence. These concerns were the catalyst for a comprehensive review led by Asma Khalil, PhD, professor of obstetrics and maternal fetal medicine at City St George’s, University of London, who sought to evaluate whether previously reported associations were supported by high-quality data.

Paracetamol is one of the most commonly used medications during pregnancy, with more than two-thirds of pregnant women taking it at some point, making the question clinically and publicly significant. The research team reviewed 43 studies conducted worldwide, including data from Europe, the United States, Japan, Brazil, South America, and New Zealand.

While some earlier studies reported a small association between prenatal paracetamol exposure and neurodevelopmental outcomes such as autism, attention-deficit/hyperactivity disorder (ADHD), or intellectual disability, many of these studies were vulnerable to bias. In several cases, associations weakened or disappeared entirely once key confounding factors were accounted for.

To address these limitations, the review prioritized high-quality studies, particularly sibling-comparison designs. These studies compare siblings born to the same mother where paracetamol was used in one pregnancy but not another, allowing researchers to control for shared genetic, environmental, and family-level factors.

Using validated tools to assess study quality and bias, the researchers found no evidence that paracetamol exposure during pregnancy increased the risk of autism, ADHD, or intellectual disability. Notably, the absence of an association was consistent across the most robust study designs, studies with low risk of bias, and those with long-term follow-up of more than 5 years.

The findings suggest that previously reported links were likely explained by other factors, such as genetic predisposition or the underlying conditions that led women to take paracetamol, including fever or infection. In these cases, the illness itself—not the medication—may have contributed to observed developmental risks.

Study authors concluded that the findings provide strong reassurance for pregnant women. Paracetamol remains safe for use during pregnancy and continues to be the recommended first-line treatment for pain and fever, in line with guidance from medical societies.

The study also highlights the importance of cautious public messaging, emphasizing that unsupported warnings can cause unnecessary anxiety and may discourage appropriate treatment. Untreated pain or fever during pregnancy carries known risks, including miscarriage, preterm birth, and other adverse outcomes, underscoring the need for evidence-based communication.

No relevant disclosures.

Reference

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