Pregnancy & Tylenol: The Truth Behind the Mistaken Association

CONFERENCE REPORTER

“There really is no evidence that Tylenol is associated with autism,” shared Jennifer L. Payne, MD, at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Miami, FL.

On September 22, 2025, the US Food and Drug Administration (FDA) announced a label change for acetaminophen (Tylenol and similar products) that reflect supposed evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and attention-deficit/hyperactivity disorder (ADHD) in children.¹ Before that, on July 21, 2025, the FDA led an expert panel on selective serotonin reuptake inhibitors and pregnancy, in which they questioned the validity of psychiatric medication use during pregnancy.²

Payne reminds clinicians that it is critical to control for confounding by indication in studies, noting that initial findings often associate medications with various outcomes due to uncontrolled factors like smoking, which can be confounding variables. Confounding by indication is an important factor to control for in studies that examine whether a medication exposure in utero is associated with a negative pregnancy or child outcome. Confounding by indication means that that the reason the medication was taken in pregnancy might result in a negative outcome rather than the medication exposure itself. For example, acetaminophen is often taken in the setting of an infection, fever, or inflammation, which may all be associated with negative pregnancy outcomes. Studies that do not control for confounding by indication may find associations between in utero medication exposure and a negative outcome that are not accurate.

Payne further explained that well-controlled studies have not found an association between Tylenol and autism, similar to how properly controlled studies have shown that antidepressants are not linked to cardiac defects once other risk factors like smoking are properly accounted for.

Dr Payne is vice chair of research, professor of psychiatry and neurobehavioral sciences, and director of the Reproductive Psychiatry Research Program at the University of Virginia in Charlottesville.

References

1. FDA Responds to Evidence of Possible Association Between Autism and Acetaminophen Use During Pregnancy. News release. September 22, 2025. Accessed June 2, 2026. https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy

2. FDA expert panel on selective serotonin reuptake inhibitors (SSRIs) and pregnancy. FDA. July 21, 2025. Accessed June 2, 2026. https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-selective-serotonin-reuptake-inhibitors-ssris-and-pregnancy-07212025