The use of Tylenol during pregnancy was not linked to autism in children born to those women.
Among more than 1.5 million children born between 1997 and 2022 including 31,098 who were exposed to Tylenol during pregnancy autism was later diagnosed in 1.8% of the exposed group and 3% of the unexposed group.
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, the report said.
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A 2024 Swedish study also found no association between autism and the use of Tylenol during pregnancy, a brand name for acetaminophen (paracetamol).
However, a 2025 review by U.S. researchers analyzing 46 earlier studies suggested a possible link between prenatal exposure to acetaminophen and neurodevelopmental conditions such as autism and attention deficit hyperactivity disorder in children. The researchers emphasized that the findings do not prove a causal relationship. They also advised that pregnant women should continue using acetaminophen when needed, at the lowest effective dose and for the shortest duration possible.
In September, the U.S. Food and Drug Administration announced it was beginning the process of updating acetaminophen’s label to include a warning that use during pregnancy may be associated with an increased risk of autism and ADHD.
Following the FDA’s announcement, U.S. President Donald Trump stated that pregnant women and infants should avoid using the drug due to its potential link to autism.
Since then, several national and international medical organizations have criticized the remarks, saying they are not supported by scientific evidence.
A month after the FDA said it would recommend limiting Tylenol use in pregnancy, U.S. Health Secretary Robert F. Kennedy, Jr. said evidence does not show that Tylenol definitively causes autism but that it should still be used cautiously.
The FDA declined to comment on the status of its planned label change.
