FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy

Sep 22, 2025 04:11PM ● By U.S. Food and Drug Administration News Release

The U.S. Food and Drug Administration initiated the process today 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.