The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and
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FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy
Agency initiates safety label change and notifies physicians of possible link
For Immediate Release: September 22, 2025
The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. The agency also issued a related
letter alerting physicians nationwide.