Review finds no evidence linking prenatal paracetamol use to increased risk of autism, ADHD

A large, methodologically rigorous systematic review and meta-analysis published January 16, 2026, in The Lancet Obstetrics, Gynaecology, & Women’s Health found no evidence that paracetamol use during pregnancy increases the risk of autism spectrum disorder, attention-deficit/hyperactivity disorder (ADHD), or intellectual disability in children.¹ The findings come amid renewed public concern following earlier reports that suggested potential neurodevelopmental risks associated with prenatal exposure to the medication.²

Prenatal paracetamol safety concerns

Paracetamol is commonly recommended during pregnancy to manage pain and fever, yet its safety has been questioned. The investigators noted that in September 2025, the United States administration suggested that paracetamol use during pregnancy might increase the risk of autism, further amplifying concerns among patients and clinicians.

Earlier meta-analyses reported small associations between prenatal paracetamol exposure and autism or ADHD, though many relied on studies vulnerable to bias, including confounding by maternal health conditions and genetic factors, noted the study investigators.

To clarify the evidence, researchers conducted the most comprehensive synthesis to date, prioritizing high-quality cohort studies with adjusted risk estimates and validated outcome measures.¹

Review of paracetamol during pregnancy

The investigators searched multiple databases for eligible studies published through September 30, 2025, ultimately including 43 cohort studies in the systematic review and 17 studies in the meta-analysis. Only studies reporting adjusted estimates were included, and quality was assessed using the Quality In Prognosis Studies (QUIPS) tool.

“The primary outcomes were the association between paracetamol exposure during pregnancy and the likelihood of autism spectrum disorder, ADHD, and intellectual disabilities, considering only sibling comparison studies with adjusted estimates and odds ratios (OR) were calculated,” wrote the study authors.

Findings revealed prenatal paracetamol exposure was not associated with an increased likelihood of neurodevelopmental disorders. When considering sibling comparison studies, paracetamol exposure during pregnancy was not associated with:

• Autism spectrum disorder (sibling comparison studies): OR 0.98 (95% CI 0.93–1.03; P = 0.45)
• ADHD (sibling comparison studies): OR 0.95 (0.86–1.05; P = 0.31)
• Intellectual disability (sibling comparison studies): OR 0.93 (0.69–1.24; P = 0·63)

When analyses were restricted to studies rated at low risk of bias, there was no association between paracetamol intake during pregnancy and:

• Autism spectrum disorder: OR 1.03 (95% CI 0.86–1.23; P = 0.78)
• ADHD: OR 0.97 (0.89–1.05; P = 0.49)
• Intellectual disability: OR 1.11 (0.92–1.34; P = 0.28

The absence of association persisted in studies with more than 5 years of follow-up.

According to the authors, the consistency of null findings across sibling comparisons and low-bias studies suggests that earlier reported associations were likely driven by confounding factors rather than a direct effect of paracetamol. Maternal pain, fever, discomfort, or genetic predisposition may explain previous signals observed in less rigorous analyses.²

Overall, the study investigators concluded that ^“Current evidence does not indicate a clinically important increase in the likelihood of autism spectrum disorder, ADHD, or intellectual disability in children of pregnant individuals who use paracetamol as directed, supporting existing recommendations on its safety.”¹

References:

1. D’Antonia 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 January 16, 2026. Accessed January 16, 2026. doi:10.1016/S3050-5038(25)00211-0

2. The Lancet Obstetrics, Gynecology, & Women’s Health: Taking paracetamol during pregnancy does not increase risk of autism, ADHD or intellectual disabilities, confirms new gold-standard evidence review. The Lancet. Press release. Accessed January 16, 2026. https://www.eurekalert.org/news-releases/1112663?