Paracetamol has been the drug of choice for fever and pain during pregnancy for many decades. Nevertheless, US President Donald Trump expressed the suspicion in September 2025 that taking paracetamol could increase the risk of autism, ADHD or intellectual disabilities in offspring. However, the study on which he based his statement suffered from methodological weaknesses. Researchers have now carried out the most rigorous meta-analysis to date of the evidence available on paracetamol in pregnancy and confirm: the drug is safe for mother and child. False warnings can even be dangerous, as untreated fever during pregnancy has been proven to increase the risk of premature births and malformations.
In September 2025, US President Donald Trump suggested that the increase in autism cases was linked to mothers taking paracetamol during pregnancy. Attention deficit hyperactivity disorder (ADHD) and intellectual disabilities may also be associated with it. His government then ordered the FDA to change the safety label for paracetamol. As the basis for his statements, Trump cited a meta-study that actually found some research that showed that children whose mothers took paracetamol during pregnancy were slightly more likely to have neurological development disorders.
Meta-analysis of reliable studies
“However, the significance of this review study was limited by the fact that it included studies of very different quality, which also recorded and defined exposure to paracetamol very differently,” explains a team led by Francesco D’Antonio from the University of Chieti in Italy. A typical problem with many studies is that they only ask afterwards whether a woman took paracetamol during pregnancy. There is a risk here that women whose children have neurological abnormalities will remember their medication better. Another confounding factor is that the illness that led to the use of paracetamol may itself have had harmful effects on the unborn child.
In order to assess the safety of the over-the-counter drug for pregnant women as reliably as possible, D’Antonio and his colleagues have now evaluated 43 high-quality studies involving millions of pregnant women and children. The team placed a particular focus on sibling studies in which children from the same mother were compared, where the mother had taken paracetamol during one pregnancy and not the other. These studies are considered particularly reliable because they take into account common genetic factors, family environment and long-term parental characteristics that cannot be completely excluded in traditional studies.
No connection with autism, ADHD etc.
The results confirm that high-quality studies cannot demonstrate a connection to maternal intake of paracetamol for either autism, ADHD or other intellectual development disorders. “Our results suggest that previously reported associations may be explained by genetic predisposition or other maternal factors such as fever or underlying pain, rather than a direct effect of paracetamol itself,” says co-author Asma Khalil from St George’s Hospital in London.
From their perspective, the message is clear: “Paracetamol is and remains a safe option during pregnancy when taken according to instructions.” The analysis thus reinforces the guidelines of important technical and regulatory authorities, including the European Medicines Agency (EMA).
Dangers of false fears
Wolfgang Paulus, head of the advisory center for reproductive toxicology at the Ulm University Women’s Hospital, reports that the Trump administration’s statements have unsettled many patients and led to increased demands for “harmless” alternatives. “However, medications such as ibuprofen or diclofenac as well as opioids can only be used with considerable restrictions during pregnancy, so they are by no means a better alternative,” he explains. “Failure to take adequate medication can also lead to complications associated with untreated pain and fever, such as miscarriage, premature birth or congenital malformations.”
The mere fact that the rumor about possible harmful effects of paracetamol has been spread could therefore endanger the health of mothers and children. “Even after correction, a false claim can linger in the back of your mind and influence behavior,” says communications scientist Anne Reinhardt from the Ludwig Maximilian University of Munich. “In the specific example, this means: Even if pregnant women know that there is no proven causal connection between occasional paracetamol use and autism, the myth that has been put into the world alone can ensure that they prefer to avoid paracetamol – contrary to medical advice.” Nevertheless, from their point of view, the current meta-study can be helpful: “Such evidence can be a central tool for correcting false narratives and supporting people in making informed health decisions.”
Source: Francesco D’Antonio (University of Chieti, Italy) et al., The Lancet Obstetrics, Gynecology, & Women’s Health, doi:10.1016/S3050-5038(25)00211-0