Debates over Tylenol, sold as acetaminophen in the US and paracetamol elsewhere in the world, have been raging ever since US President Donald Trump urged pregnant women not to take it, warning that it could cause autism in children. In line with what Trump said, the US Food and Drug Administration initiated a label change for acetaminophen or Tylenol to warn pregnant women about the increased risk of neurological conditions such as autism and ADHD in children.
Acetaminophen has been the most trusted and commonly recommended pain reliever for pregnant women, and there is no substitute for it currently, as other over-the-counter painkillers like ibuprofen cannot be taken during pregnancy, especially after 20 weeks of gestation.
The FDA press release noted that there has been evidence of a correlation between acetaminophen use during pregnancy and subsequent diagnosis of conditions like autism and ADHD. It states that multiple large-scale cohort studies, including the Nurses’ Health Study II and the Boston Birth Cohort, have found this association. Risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy, some studies noted.
The FDA note also added that a causal relationship has not been established, and observed that acetaminophen is the only over-the-counter drug approved for use to treat fevers during pregnancy. It also noted that high fevers in pregnant women can pose a risk to their children, and aspirin and ibuprofen have well-documented adverse impacts on the fetus.
Yale School of Public Health Associate Professor Dr. Zeyan Liew, PhD, MPH, who has extensively researched bout neurodevelopmental disorders, says there is no proven causal relationship between the drug and autism.
While associations between frequent or prolonged acetaminophen use during pregnancy and higher rates of neurodevelopmental disorders in children have been found during studies, they aren’t conclusive, says Dr Liew.
He notes that underlying illness or genetic predisposition could play a role in autism development. A 2024 study showed that the relationship between prenatal acetaminophen use and autism disappeared when accounting for genetics or sibling status.
What is Tylenol?
Acetaminophen/paracetamol, marketed as Tylenol, is one of the most widely used over-the-counter medications to relieve pain and reduce fever. It is generally considered safe when taken at recommended doses during pregnancy. It is frequently recommended during pregnancy as it is believed to be safer than many painkillers, which is why it is often the first medication that expectant mothers will take for headaches, body pain, or a high fever.
Risks of not addressing high fever during pregnancy
“Maternal fever or higher maternal body temperatures may be harmful to the fetus due to the increased risks of various types of complications, such as neural tube defects. Therefore, the risks associated with treating maternal fever may actually be less risky than the unproven concerns of maternal fever potentially leading to autism,” says Dr. Astik Joshi, Child & Adolescent expert, and Forensic Psychiatrist, Fortis Hospital Shalimar Bagh.
“Undoubtedly, if left untreated, high fever can be a problem in pregnancy. It can lead to more severe complications such as dehydration, preterm labor, and even birth defects, with the risk increased during the first trimester, says Dr. Mannan Gupta, Chairman & HOD- Obstetrics & Gynaecology, Elantis Healthcare New Delhi.
Is Tylenol linked to autism as claimed by Donald Trump?
“Currently, there is no strong scientific evidence that taking Tylenol while pregnant is related to autism. Claims by Donald Trump are based on observational, or early studies, which do not establish causation,” says Dr Gupta.
NHS guidelines in the UK say, “Paracetamol is the first choice of painkiller if you’re pregnant. It’s commonly taken during pregnancy and does not harm your baby.”
A 2024 study, published in JAMA, involving around 2.5 million children in Sweden found no causal link between in utero exposure to acetaminophen and neurodevelopmental disorders like autism spectrum disorder or attention deficit hyperactivity disorder.
Are there any studies that connect Tylenol to autism
Several observational studies have evaluated the potential link between extended or high-dosage prenatal exposure to acetaminophen and autism risk. However, while some of these studies show a correlation, none of them draw definitive conclusions about a causative link. Well-controlled studies with the same sample sizes of each group are still being conducted, and at this time, the establishment of a recommendation against using Tylenol during pregnancy (on the basis of autism) has not yet been made by the appropriate medical societies.
A 2025 review published in Environmental Health found a link between prenatal acetaminophen exposure and increased risks of these conditions. However, researchers say the study does not prove the drug caused the outcomes.
Other scientifically-proven side effects of Tylenol
Tylenol, when taken at the recommended dose, is usually considered safe. The rare side effects include allergic reactions, skin rash, or liver damage due to overdosing. Prolonged or excessive use of Tylenol can increase the dangers of liver toxicity. Pregnant women should carefully read the dosage instructions and consider consulting their physician if they plan to take it frequently, says Dr. Gupta.
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