Copenhagen: The use of Tylenol by women during pregnancy was not associated with autism in their children, according to results of a nationwide study in Denmark published on Monday. Among more than 1.5 million children born between 1997 and 2022, including 31,098 exposed to Tylenol in the womb, autism was later diagnosed in 1.8% of exposed children and 3% of the unexposed group, Danish researchers reported in JAMA Pediatrics.
According to Ghana Web, the lack of an association persisted after researchers accounted for individual risk factors, including the dose of the drug and the trimester of pregnancy in which it was used. Furthermore, a 2024 Swedish study also found no link between autism and the use of Tylenol, which is a brand name for acetaminophen and paracetamol.
Additionally, a 2025 review by U.S. researchers of 46 earlier studies suggested a possible link between prenatal acetaminophen exposure and neurodevelopmental disorders such as autism and attention deficit hyperactivity disorder in children. However, the researchers emphasized that the study does not prove the drug caused those conditions and advised that pregnant women should continue to use it as needed, at the lowest possible dose and for the shortest possible period.
In September, the U.S. Food and Drug Administration announced it was beginning the process for a label change for acetaminophen to warn that its use by pregnant women may be associated with an increased risk of autism and ADHD. At the time of the FDA announcement, U.S. President Donald Trump stated that pregnant women and infants should not take the drug because of its link with autism.
Since then, national and international medical groups have criticized the president's comments, asserting they were not evidence-based. A month after the FDA's statement about recommending limiting Tylenol use in pregnancy, U.S. Health Secretary Robert F. Kennedy, Jr. said that evidence does not show that Tylenol definitively causes autism but advised it should still be used cautiously.
The FDA has declined to comment on the status of its planned label change.