The Trump administration announced Monday that the Food and Drug Administration will add warnings to acetaminophen products, including Tylenol, after officials said studies suggested a possible connection between use of the drug during pregnancy and autism in children.
In a statement from the FDA, the agency said it is beginning the process of updating product labeling and has sent a letter to physicians “to alert them to evidence of a possible association” between prenatal acetaminophen use and later diagnoses of autism and ADHD. The FDA stressed that the findings come from observational studies and “causality has not been established.”
The agency also warned that untreated fever and pain can pose risks during pregnancy, noting that acetaminophen remains the only over-the-counter option for fever relief.
ACOG: Acetaminophen still safe for pregnancy when needed
The American College of Obstetricians and Gynecologists (ACOG) countered the administration’s announcement, saying that “science does not support claims that acetaminophen use in pregnancy causes autism.” In its guidance for physicians, ACOG reaffirmed that acetaminophen remains safe for short-term use during pregnancy when recommended by a doctor.
“Failing to treat fever and pain during pregnancy can have negative outcomes,” the group said, advising patients to use the lowest effective dose for the shortest possible time.
AAP: No evidence pregnant women should avoid Tylenol
The American Academy of Pediatrics (AAP) also responded to the White House announcement. In a statement released Monday, the AAP said current evidence is not strong enough to recommend that pregnant women avoid acetaminophen and cautioned against overstating the risk.
The group called for more rigorous studies while noting that acetaminophen is often the only safe over-the-counter medicine for treating fever during pregnancy.
Does Tylenol cause autism during pregnancy?
No. The FDA said studies have shown an “association” between frequent or prolonged acetaminophen use in pregnancy and later autism diagnoses, but that does not prove causation. ACOG echoed that point in its clinical FAQ, stressing that the science does not show acetaminophen causes autism.
Is Tylenol Safe to take while pregnant?
Yes — when used correctly. Both ACOG and the AAP say acetaminophen remains a reasonable and safe choice for pregnancy when medically necessary. They recommend limiting use to the smallest effective dose and shortest duration possible (ACOG guidance; AAP statement).
What are the risks of not treating fever or pain in pregnancy?
Untreated high fever and severe pain can harm both the pregnant person and the fetus. ACOG warned in its guidance that avoiding acetaminophen altogether may create greater risks than carefully managed use.
What will change on Tylenol labels?
The FDA said new warning labels will be added to acetaminophen products in the coming months. The agency’s full announcement is available here.
