Is It Safe to Take Acetaminophen While Pregnant?
What is acetaminophen?
Acetaminophen, also known as paracetamol, and sold under the trade name of Tylenol®, was initially discovered by two doctors in the 1880s who found the primary chemical component reduced high fevers. However, it would take years of research and development before acetaminophen would become widely used in its current form in the 1950s. It is used commonly to treat not just fevers but also pain.
Why is acetaminophen used in pregnancy?
Acetaminophen may be recommended by your healthcare provider during pregnancy to help reduce a fever or relieve pain. If you experience pain or fever during pregnancy, it is important to call your healthcare provider so they can evaluate the cause and recommend the best course of treatment. High fevers and untreated pain can cause stress on the mother during pregnancy. Additionally, fevers have been associated with birth defects.
What are the risks of taking acetaminophen?
Acetaminophen is generally a safe medication when used as directed. If acetaminophen is taken at higher than recommended doses, it can cause liver damage. The typical recommended dose is 325 to 650 mg every 4 to 8 hours to not exceed 4000 mg in a 24-hour period. Read the directions on the label carefully. Do not take more or take it more frequently than recommended. Also pay attention to all the sources of acetaminophen as acetaminophen is present in a variety of over-the-counter combination products such as those to treat cold and flu symptoms.
Ask your doctor or pharmacist if you have any questions about whether you should take acetaminophen or whether the products you take contain acetaminophen.
Has acetaminophen use in pregnancy been associated with higher risks of autism in children?
Acetaminophen has long been recommended as a fever reducer and pain reliever in pregnant women. Due to its widespread use, several reports and studies have been published assessing a potential link between acetaminophen use and the diagnosis of neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), Attention-Deficit Hyperactivity Disorder (ADHD), and intellectual disabilities in children whose mothers took acetaminophen during pregnancy. A study of close to 2.5 million pregnancies in a 25-year period was published in the Journal of American Medical Association (JAMA) in 2024 and results failed to show an increased risk of ASD, ADHD, or intellectual disability diagnoses among children exposed to acetaminophen in utero versus those not exposed to acetaminophen. This study also used a sibling group to help control for genetic variables that can influence the diagnoses of any of these disorders and still failed to show an increased risk of ASD, ADHD, or intellectual disability diagnosis based on in utero acetaminophen exposure.
What do the experts say?
On September 22, 2025, the Food and Drug Administration (FDA) released a drug warning statement indicating plans to revise acetaminophen labels to include warnings about a potential increased risk of neurodevelopmental disorders, such as ASD and ADHD, in children exposed to acetaminophen during pregnancy, although noting that there is no evidence to date that acetaminophen causes these disorders. The FDA recommends that pregnant patients have risk and benefit discussions with their healthcare providers regarding use of acetaminophen during pregnancy.
The American College of Obstetricians and Gynecologists (ACOG), a leading organization supporting healthcare providers who care for women in pregnancy, continues to state that acetaminophen use in pregnancy is safe and supports its use as needed, in moderation and with the advice of a healthcare provider.
The American Academy of Pediatrics, a leading organization supporting pediatricians caring for children, has stated that there are no data to support claims that acetaminophen use during pregnancy causes ASD or other neurodevelopmental disorders. The AAP continues to support acetaminophen use in children to treat fevers and pain when used as directed and with the advice of a healthcare provider.
In summary…
At this point in time, the evidence continues to point to use of acetaminophen during pregnancy as safe. As always, pregnant women should seek the advice of a healthcare provider and have an open discussion regarding the risks and benefits before taking any medications during pregnancy.