09/26/2025
Statement released by the FDA on the use of acetometophin during pregnancy
U.S. FOOD & DRUG ADMINISTRATION
September 22, 2025
Notice to Physicians on the Use of Acetaminophen During Pregnancy
In recent years, evidence has accumulated 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. Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy to childbirth. These concerns may be magnified by the fact that a very young child’s liver may still be developing and thus a child’s ability to metabolize the drug may be limited.
To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication.
In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers. This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the fetus.
Sincerely,
Martin A. Makary, M.D., M.P.H.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
