On September 22, 2025 the U.S. Food and Drug Administration changed the label for Tylenol (acetaminophen) to suggest that use of it by pregnant women may be associated with an increased risk of autism and attention deficit disorder (ADHD) in children. Since this is one of the most often used medications in pregnancy, how should you react to this change in policy? Let’s look at the evidence.

The question about safety of acetaminophen in pregnancy has been studied for over a decade. In 2015 the FDA conducted a review of the subject and concluded that there was no causal relationship between acetaminophen and ADHD. Further studies by the Society of Maternal-Fetal Medicine reached the same conclusion. In 2021 the American College of Obstetricians and Gynecologists issued a statement that the standard of care for using acetaminophen in pregnancy was unchanged. An August 2025 study review included 10 new studies and concluded no significant association between prenatal acetaminophen and neurodevelopmental outcomes.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has made finding possible causes of autism a priority for research, launching the $50 million Autism Data Science initiative. Yale School of Public Health Professor Dr Zeyan Liew has spent years investigating causes of neurodevelopmental disorders and he says that there is no proven causal relationship between acetaminophen use and autism. Other factors, such as underlying illness or genetic predisposition could play role in causing autism.

Maternal conditions for which acetaminophen is recommended, such as fever, migraines, headaches and pain, can lead to significant maternal and fetal morbidity and mortality if not treated. For example, fever during pregnancy can lead to an increased risk of birth defects. In considering whether to take it, we must think about whether there is a greater benefit or a greater risk.

Our parent organization, ACOG, reaffirms that acetaminophen remains the pain medication and anti-fever medication of choice in pregnancy. Unfortunately, there is no equivalent alternative medication as other over the counter pain medications are recommended to be avoided due to their risks. Using acetaminophen at the lowest amount that is effective for the shortest duration of time is the safest approach. Furthermore, the current evidence does not support a link between developmental disorders and use in pregnancy.