Sept. 23, 2025 – As if pregnancy didn't come with enough worries, this week's headlines added another.
President Donald Trump announced on Monday that the FDA would consider changing the safety label on acetaminophen – commonly known by the brand name Tylenol – saying that taking the drug during pregnancy is linked to a "very increased risk of autism."
The move prompted rebuttals from many major medical organizations, leading doctors, and the drug's supplier, who say the drug is safe to use during pregnancy under a doctor's care. Avoiding it – particularly if you're having pain and a fever – could lead to serious, more established risks for mom and baby, including preterm birth. As the American College of Obstetricians and Gynecologists (ACOG) put it: "Suggestions that acetaminophen use in pregnancy causes autism are not only highly concerning to clinicians but also irresponsible when considering the harmful and confusing message they send to pregnant patients, including those who may need to rely on this beneficial medicine during pregnancy."
While the president's announcement referred to studies, experts are urging caution in how people interpret them. Here's what those experts – and your doctor – want you to know.
1. There's no proof Tylenol causes autism.
The U.S. administration has mostly focused on a scientific paper from August that analyzed 46 studies and found an association between acetaminophen use during pregnancy and increased risk of neurodevelopmental disorders, such as autism and attention deficit hyperactivity disorder (ADHD).
The key word here is association – a statistical term that means the link is not likely due to chance, but also isn't strong enough to prove cause and effect. This is a crucial limitation because it means other factors may be involved.
Consider this example from epidemiologist Brian Lee, PhD: "Eating ice cream is associated with drowning, but it's not causal," the Drexel University professor told NBC. "[H]ot weather causes someone to eat ice cream and hot weather causes someone to go swimming, increasing the risk of drowning. So the association does not mean causation."
Other research shows no link at all. A 2024 study from Sweden found that about 7% of children were exposed to acetaminophen in the womb, and by age 10, they were no more likely than their unexposed siblings to be diagnosed with autism, ADHD, or intellectual disability. The U.S. Department of Health and Human Services acknowledged this in its official statement, saying the "FDA also recognizes that there are contrary studies showing no association and that there can be risks for untreated fever in pregnancy, both for the mother and fetus."
In fact, no one knows what causes autism – but experts speculate it's likely a complex combination of genetic and environmental factors, rather than any single factor alone.
2. Acetaminophen is still the safest pain reliever for pregnant people.
On this, everyone – including federal health officials – agrees. In a letter to doctors dated Monday, FDA Commissioner Martin Makary, MD, MPH, said "acetaminophen is the safest over-the-counter alternative" for reducing pain and fever during pregnancy.
Nonsteroidal anti-inflammatory drugs (NSAIDs) – like aspirin, ibuprofen, and naproxen – have been shown to cause kidney problems in unborn babies. "After around 20 weeks of pregnancy, the unborn babies' kidneys produce most of the amniotic fluid, so kidney problems can lead to low levels of this fluid. Amniotic fluid provides a protective cushion and helps the unborn babies' lungs, digestive system, and muscles develop," the FDA warns.
The ACOG says it's OK to take acetaminophen for pain or fever "as needed, in moderation, and after consultation with a doctor."
The FDA's official information page for acetaminophen says, "To date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes."
The main known risk of taking acetaminophen long-term is liver damage for the mother, said Judette Louis, MD, MPH, chair of the Publications Committee of the Society for Maternal-Fetal Medicine. The U.S. administration's call to limit use to the lowest effective dose for the shortest duration "isn't anything new," she said.
"Most people in pregnancy use Tylenol for brief periods of time to address an acute illness –something that just came on, or if they have a chronic condition that is just exacerbated," said Louis.
3.The safety label change could take months – or not happen at all.
The process of changing a drug's safety label is long and complex. First, the FDA must notify the drugmaker of new information about its drug's safety, and then there is back-and-forth communication, including a chance for a drugmaker to explain why a change isn't warranted.
The Tylenol website has a pop-up message stating, "Tylenol is one of the most studied medications in history – and is safe when used as directed by expecting mothers, infants and children. The facts remain unchanged: over a decade of rigorous research, endorsed by leading medical professionals, confirm there is no credible evidence linking acetaminophen to autism."
The FDA does have the authority to force a labeling change if a drugmaker and the FDA cannot reach a consensus. The agency may also reject or alter a proposed label change.
4. If you're pregnant, your doctor wants to know if you're having pain.
Pain can be a sign of a pregnancy complication, so it's important to let your doctor know. For minor pain, your doctor may suggest other strategies – such as massage, aromatherapy, or heat or cold therapy, said Louis.
Major pain during pregnancy is not uncommon.
"Just because you're pregnant doesn't mean you can't break a bone or get appendicitis," she said. "All the real-life situations where you would use Tylenol when you're not pregnant still happen when you're pregnant."
She would advise pregnant patients to take Tylenol for migraines or other pain that disrupts sleep or interferes with daily activities like caring for their children.
5. Most pregnant people who take Tylenol deliver healthy babies.
Taking acetaminophen under a doctor's care can help keep both baby and mother healthy, because "untreated fever and pain during pregnancy carry significant maternal and infant health risks," according to a statement from the Society for Maternal-Fetal Medicine. In the first trimester, untreated fever "increases the risk of miscarriage, birth defects, and premature birth, and untreated pain can lead to maternal depression, anxiety, and high blood pressure," the society said.
If you took acetaminophen during pregnancy and are now worried about your child's autism risk, don't be, said Louis. "The most well-established risk factor for autism and neurodevelopmental disabilities is family inheritance."
