Current evidence does not link paracetamol use in pregnancy to autism, attention-deficit hyperactivity disorder (ADHD) or intellectual disabilities, according to a wide-ranging review published in The Lancet Obstetrics, Gynaecology and Women’s Health. The findings, from an international team of researchers, support existing guidance that paracetamol — known as Tylenol in the United States — remains safe to use during pregnancy when taken as directed.
The review comes after U.S. President Donald Trump said in September there had been a “meteoric rise” in autism and suggested Tylenol could be a cause, adding that pregnant women should “tough it out.” His comments drew swift criticism from autism advocates and scientists.
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For the new paper, academics searched research databases for all studies reporting risk estimates for autism spectrum disorder, ADHD and intellectual disabilities, and included analyses that compared pregnancies with and without paracetamol exposure. Eligible studies assessed outcomes via validated questionnaires or medical records, and accounted for maternal health conditions and other treatments.
In total, 43 studies were included in the systematic review and 17 in the meta-analysis, the method used to aggregate findings across multiple studies. Several so-called sibling comparison studies — which compare outcomes among children born to the same mother across pregnancies with and without paracetamol exposure — were prioritized because they help account for family and genetic factors.
The authors concluded that paracetamol exposure during pregnancy was “not associated with the risk” of autism spectrum disorder, ADHD or intellectual disabilities. “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,” the paper states.
“We found no clinically important increase in the risk of autism, ADHD or intellectual disability (among) children where the mothers took paracetamol during pregnancy,” said study lead author Professor Asma Khalil, a consultant obstetrician and fetal medicine specialist at St George’s Hospital, London. “And this is the important message to the millions of pregnant individuals, paracetamol is safe to use in pregnancy.”
“It remains to be the first-line treatment that we would recommend if pregnant women have pain or fever in pregnancy, and it’s also consistent with recommendations or the guidelines by various national or international bodies,” she added.
Gráinne McAlonan, Professor of Translational Neuroscience at King’s College London, who was not involved in the study, said the work should reassure expectant mothers. “Expectant mothers do not need the stress of questioning whether medicine most commonly used for a headache could have far-reaching effects on their child’s health,” she said. “This thorough and clear study approached the question by conducting both a substantial systematic review of the literature and a meta-analysis of eligible studies. Importantly, it prioritised sibling design studies to account for family history, which is crucial.”
“This confirmed that there is no relationship between taking paracetamol in pregnancy and a higher likelihood of autism, ADHD or intellectual disabilities in the offspring,” McAlonan added. “While the impact of last year’s announcement has been extensive, I hope the findings of this study bring the matter to a close.”
The conclusions align with existing positions from European regulators, including the European Medicines Agency, that paracetamol can be used in pregnancy as recommended. The study’s emphasis on sibling comparison designs and careful control of maternal conditions and co-treatments strengthens the evidence base that routine, directed use of paracetamol does not increase neurodevelopmental risk.
The review’s message is clear: for pain and fever in pregnancy, paracetamol remains the first-line option. Experts caution that decisions about medication in pregnancy should be grounded in robust evidence, not speculation — and the latest analysis finds no link between paracetamol use and autism, ADHD or intellectual disabilities.
By Abdiwahab Ahmed
Axadle Times international–Monitoring.
