Taking paracetamol during pregnancy does not increase the risk of autism, attention-deficit hyperactivity disorder (ADHD), or intellectual disability in children. This conclusion comes from the most comprehensive analysis of evidence to date, published today in The Lancet Obstetrics, Gynaecology & Women’s Health, and led by researchers from City St George’s, University of London.
The study involved a systematic review and meta-analysis of 43 existing studies to evaluate the safety of paracetamol use during pregnancy. This research was prompted by public concerns following claims in September 2025 suggesting that paracetamol might adversely affect neurodevelopment, potentially increasing the risk of autism.
Rigorous Analysis Dispels Previous Concerns
Earlier studies had reported small associations between paracetamol use in pregnancy and increased risks of autism. However, these studies were often criticized for biases, including limited data collection and a lack of sibling comparisons to account for family history, which is crucial for accurate analysis.
The research team focused on 43 high-quality studies with rigorous methodologies, comparing pregnancies where mothers took paracetamol to those where they did not. They pooled results from sibling comparison studies, which compared siblings born to the same mother, with one pregnancy involving paracetamol exposure and another not. This approach controls for shared genetics, family environment, and long-term parental characteristics that traditional studies may overlook.
Across the sibling-comparison studies, data included 262,852 children assessed for autism, 335,255 for ADHD, and 406,681 for intellectual disability. The findings confirmed that paracetamol use in pregnancy was not linked to these developmental disorders.
Expert Opinions and Reassurances
Professor Asma Khalil, Professor of Obstetrics and Maternal Fetal Medicine at City St George’s, University of London, and Consultant Obstetrician, who led the study, emphasized the importance of these findings:
“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. The message is clear – paracetamol remains a safe option during pregnancy when taken as guided.”
Professor Khalil further noted the significance of this reassurance, as paracetamol is the first-line medication recommended for pregnant women experiencing pain or fever. She stressed that women should feel confident in using paracetamol to manage symptoms safely.
Quality Assessment and Study Limitations
All studies were evaluated using the Quality In Prognosis Studies (QUIPS) tool, which assesses various factors in research methodology to determine the risk of bias. The lack of association between paracetamol use during pregnancy and developmental disorders was consistent in studies deemed low risk for bias and those with follow-up periods exceeding five years.
Nonetheless, the authors acknowledged limitations, such as the inability to analyze smaller groups based on the trimester of pregnancy when paracetamol was consumed, the sex of the baby, or the frequency of paracetamol use. These data were insufficiently reported in existing studies.
Implications for Medical Guidance
Overall, the study’s findings support recommendations from major medical organizations worldwide. Researchers hope this gold-standard review will dispel any skepticism regarding paracetamol use during pregnancy. Avoiding paracetamol for significant pain or fever can expose both mother and baby to known risks, particularly untreated maternal fever.
As the conversation around medication safety during pregnancy continues, this comprehensive analysis provides much-needed clarity and reassurance for expectant mothers and healthcare providers alike. The study underscores the importance of evidence-based guidance in ensuring the health and well-being of both mothers and their children.
