Paracetamol use in pregnancy is safe, major review confirms

Taking paracetamol during pregnancy does not increase the risk of autism, ADHD or intellectual disability in children, according to a comprehensive study published in The Lancet Obstetrics, Gynaecology, and Women’s Health.

The research reviewed 43 studies and found no credible evidence of harm. It concluded that earlier studies reporting weak associations were likely to have been affected by confounding factors such as underlying maternal illness, fever or genetic predisposition.

Researchers from City St George’s, University of London, led the systematic review and meta-analysis in response to claims by the US government in September 2025 suggesting risks involving the use of paracetamol during pregnancy.

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According to The Lancet, those warnings were based on previous observational studies that have since been criticised for poor methodology and failure to account for familial risk.

The new review prioritised sibling-comparison studies – a method that compares siblings born to the same mother, where one pregnancy involved paracetamol exposure and the other did not.

These studies, involving hundreds of thousands of children, found no association between prenatal paracetamol use and autism, ADHD or intellectual disability.

The authors of the review noted that avoiding paracetamol unnecessarily could pose greater risks. Untreated fever, for example, has been linked to miscarriage, preterm birth and congenital anomalies.

Professor Asma Khalil, lead author and consultant obstetrician, said: ‘The message is clear – paracetamol remains a safe option during pregnancy when taken as guided.

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‘This is important as it is the first-line medication we recommend for pregnant women in pain or with a fever, and so they should feel reassured.’

Following the publishing of the findings, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement from Dr Alison Cave, its chief safety officer, who reiterated: ‘Paracetamol remains safe to use during pregnancy.’

Dr Cave added: ‘This large-scale analysis of the evidence found no link between taking paracetamol during pregnancy and autism, ADHD or disability in children.

‘Paracetamol has been used for many years and is the recommended first choice for treating pain or fever during pregnancy. When taken as directed, it is safe and effective.’

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The statement reiterates the MHRA’s original response to baseless, unevidenced claims made by US President Donald Trump last September linking the use of paracetamol in pregnancy to an increased risk of autism.

The Department of Health and Social Care also issued a briefing stating that paracetamol is safe to use during pregnancy and that paracetamol ‘remains a recommended painkiller during pregnancy when used as directed’.