Addressing your questions about pregnancy and acetaminophen
September 26, 2025
In light of a recent government announcement, many patients are asking about the safety of using acetaminophen during pregnancy. Acetaminophen, also called paracetamol, is a mild pain-relieving drug commonly found in over-the-counter pain and cold medications such as Tylenol.
Here’s what you need to know:
What did the FDA announce?
The Food and Drug Administration (FDA) initiated the process for a label change for acetaminophen to reflect some 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. The agency also issued a related letter alerting physicians nationwide.
Should I stop taking acetaminophen if it was directed by my physician?
No. You should continue to follow the direction of your physician. Acetaminophen remains the analgesic and antipyretic medication of choice during pregnancy. Analgesics are medicines used to reduce pain, while an antipyretic is medicine to reduce a fever.
Should I be concerned if I have taken acetaminophen at any point during my pregnancy?
No. You should talk with your doctor, who can advise you based on your specific health needs.
Should I consider other pain medications?
No. Unless your physician directs otherwise due to your specific medical conditions, the FDA notice and professional organizations’ recommendations are that acetaminophen is the safest over-the-counter option in pregnancy among all analgesics and antipyretics.
What do professional medical societies say?
Below are some helpful links to statements from professional medical organizations:
What do the studies show about taking acetaminophen during pregnancy?
The FDA announcement notes that an association between acetaminophen and neurologic conditions such as autism and ADHD has been described in some studies. However, an actual cause-and-effect relationship has not been established, and in other scientific reports, no association has been observed.
The use of acetaminophen during pregnancy has been studied for more than a decade, including comprehensive reviews for safety by the FDA in 2015 and the Society for Maternal-Fetal Medicine in 2017. Neither of these reviews found a causal connection between acetaminophen use and autism or other neurologic conditions.
The literature is contradictory in part because studies exploring these associations have limitations, including reliance on maternal self-reports of acetaminophen usage and childhood outcomes, limited information on timing, dose, and duration of exposure, lack of information on postnatal acetaminophen intake, and a lack of information about familial or genetic factors.
The recent analysis underlying the FDA statement included 46 reports with 10 published in the last four years. Overall, they report an association between acetaminophen use and neurodevelopmental disorders; however, the majority of the included studies have the aforementioned limitations. Only two studies adequately addressed genetic and familial factors, and neither found an association between prenatal acetaminophen and neurodevelopmental outcomes.
To talk with a physician about your pregnancy, make an appointment by calling 214-645-3838 or request an appointment online.
