For years, a cloud of anxiety has hovered over one of the most commonly used medicines in pregnancy. Paracetamol, long considered the safest option for pain and fever relief for expectant mothers, found itself at the centre of global concern after a series of studies hinted at a possible link with autism and attention-deficit hyperactivity disorder (ADHD) in children.
The debate escalated further last year when former US President Donald Trump publicly echoed these fears.
A new, comprehensive study published in The Lancet Obstetrics, Gynaecology and Women’s Health now delivers what researchers are calling the clearest answer yet: paracetamol use during pregnancy does not increase the risk of autism, ADHD or intellectual disability in children.
Prof Asma Khalil, professor of obstetrics and maternal foetal medicine at City St George’s, University of London, said the analysis shows that earlier associations were likely driven by genetic factors or maternal illness rather than paracetamol use itself. Once sibling comparisons were factored in, the apparent risks disappeared.
"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 reportedly said.
What sets this research apart is not just its scale but its methodology. Led by researchers from City St George’s, University of London, the study analysed evidence from 43 previous studies, making it the most rigorous review conducted so far on this question.
Crucially, the researchers went beyond conventional observational studies which often struggle to separate correlation from causation. Instead, they focused on sibling-comparison studies, a powerful design that compares siblings born to the same mother where one pregnancy involved paracetamol use and another did not. This approach helps control for shared genetics, family environment and long-term parental factors that can otherwise skew results.
The dataset was extensive, with 262,852 children assessed for autism, 335,255 children assessed for ADHD and 406,681 children assessed for intellectual disability
Across all these outcomes, the conclusion was consistent: no increased risk linked to paracetamol exposure in pregnancy.
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Researchers point out that earlier studies, which raised alarms, often failed to account for critical confounders, including maternal illness and genetic predisposition.
"This study finally puts the controversy to rest. Paracetamol has been used safely in pregnancy for decades. When taken in the correct dose and for the right indication, there is no evidence linking it to autism or ADHD," a Mumbai-based practising obstetrician from the Federation of Obstetrics and Gynaecologists’ Society of India (FOGSI) told THE WEEK.
Avoiding treatment for pain or fever can actually pose greater risks to both the mother and the baby, say experts.
Conditions such as fever, infection or chronic pain—common reasons for taking paracetamol are themselves known to influence pregnancy outcomes. Without accounting for these factors, previous research may have wrongly attributed risk to the medication rather than the underlying illness.
Paracetamol remains the first-line medication recommended globally for pain and fever during pregnancy, largely because alternatives such as non-steroidal anti-inflammatory drugs (NSAIDs) and opioids carry clearer safety concerns.
Researchers caution that fear-driven avoidance of paracetamol could expose both mother and baby to known risks, particularly when fever is left untreated.
All included studies were assessed using the Quality In Prognosis Studies (QUIPS) tool, which evaluates how research design and execution may influence results. The findings strongly reinforce existing guidelines issued by major medical bodies worldwide.
Indian obstetricians say the study should help settle the debate that has caused widespread anxiety among expectant mothers.
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Paracetamol has been used very safely in pregnancy for decades and remains the safest painkiller we prescribe to expecting mothers. Occasional use for fever or pain, at recommended doses, has not been shown to cause harm to the fetus. Even at slightly higher doses, adverse effects are extremely rare, and there is no proven evidence linking paracetamol use in pregnancy to autism or ADHD,” said Dr Surbhi Siddhartha, Consultant Obstetrician and Gynaecologist, Motherhood Hospital, Kharghar.
“A typical dose of 500 mg for fever is routinely prescribed during pregnancy. Problems are theoretically discussed only with very high and prolonged doses taken continuously over long periods, which is not how paracetamol is normally used in clinical practice,” Dr Siddhartha added.
Taken together, the evidence delivers a clear message: paracetamol, when taken at recommended doses, remains a safe and effective option during pregnancy and avoiding it unnecessarily may do more harm than good.
