Study finds no link between Tylenol use during pregnancy and autism
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, reports BritPanorama.
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.
The absence 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, the report said.
A 2024 Swedish study also confirmed no link between autism and pregnancy use of Tylenol, a brand name for acetaminophen and paracetamol.
A 2025 review by U.S. researchers of 46 earlier studies did suggest a possible connection between prenatal acetaminophen exposure and neurodevelopmental disorders such as autism and attention deficit hyperactivity disorder in children. However, the researchers cautioned that their study does not prove the drug caused those conditions. They advised pregnant women to continue using acetaminophen as needed, at the lowest possible dose and for the shortest duration.
In September, the U.S. Food and Drug Administration (FDA) announced it was initiating the process for a label change for acetaminophen, warning that its use by pregnant women may be associated with an increased risk of autism and ADHD. At that time, U.S. President Donald Trump stated that pregnant women and infants should not take the drug due to its alleged link with autism.
Since the president’s comments, national and international medical groups have decried these assertions as lacking empirical support, describing them as unsubstantiated. A month later, U.S. Health Secretary Robert F. Kennedy, Jr. remarked that while current evidence does not definitively show Tylenol causes autism, it should be used cautiously.
The FDA has declined to comment on the status of its planned label change as concerns continue to mount regarding Tylenol’s safety during pregnancy.
The ongoing debate underscores the complexities surrounding medication use during pregnancy and the need for further research to clarify potential risks.