Is Tylenol Safe During Pregnancy? The Autism Question, the FDA and ACOG

Is Tylenol (acetaminophen) safe during pregnancy?

The American College of Obstetricians and Gynecologists (ACOG) says acetaminophen, sold in the US as Tylenol, is still the medicine of choice for pain and fever in pregnancy. The UK's medicines regulator, the MHRA, says the same of paracetamol, which the World Health Organization notes is another name for acetaminophen. In September 2025 the FDA started a label change about a possible link with autism and ADHD, while stating that a causal relationship has not been established.

As with any medicine in pregnancy, check with your doctor, midwife or pharmacist before you take it. ACOG says to talk with your ob-gyn before taking acetaminophen for pain, fever or headaches, and the MHRA says pregnant women should speak to their doctor, pharmacist or midwife if they have questions about it.

What did the FDA say about Tylenol and autism?

On September 22, 2025, the FDA said it had started the process of changing the acetaminophen label to reflect evidence that use in pregnancy may be associated with a higher risk of autism and ADHD in children, and it sent a letter to doctors nationwide. The FDA named two large studies that found this association, the Nurses' Health Study II and the Boston Birth Cohort. It added that some studies describe the risk as most pronounced when acetaminophen is taken chronically throughout pregnancy.

In the same announcement the FDA wrote that "a causal relationship has not been established and there are contrary studies in the scientific literature." The FDA's letter asks doctors to consider minimizing acetaminophen for routine low-grade fevers in pregnancy, balanced against the fact that it is "the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics."

FDA Commissioner Marty Makary said that "the choice still belongs with parents" and that it remains reasonable for pregnant women to use acetaminophen in certain scenarios. The FDA also noted that acetaminophen is the only over-the-counter drug approved to treat fever in pregnancy, and that high fevers in pregnancy can pose a risk to the baby.

What do ACOG, the MHRA and the WHO say?

ACOG, the MHRA and the WHO all say the evidence does not show that acetaminophen in pregnancy causes autism. In a practice advisory issued in September 2025, ACOG reaffirmed acetaminophen as the pain and fever medicine of choice in pregnancy and said no change in clinical practice is warranted. ACOG advises judicious use at the lowest effective dose for the shortest necessary time, in consultation with an ob-gyn or other obstetric care professional.

The MHRA, which regulates medicines in the UK, told health professionals on September 23, 2025 that there is no evidence that taking paracetamol during pregnancy causes autism in children. On January 17, 2026, after a review in The Lancet Obstetrics, Gynaecology, & Women's Health found no evidence that paracetamol in pregnancy raises the risk of autism, ADHD or intellectual disability, the MHRA said paracetamol continues to be the safest option for pain and fever in pregnancy.

The World Health Organization said on September 24, 2025 that there is currently no conclusive scientific evidence confirming a link between acetaminophen in pregnancy and autism. The WHO added that any medicine should be used with caution in pregnancy, especially in the first three months, and in line with advice from health professionals.

Does taking Tylenol during pregnancy cause autism?

None of these bodies says that it does: the FDA says a causal relationship "has not been established," and ACOG says the current weight of evidence does not support one. They differ on how much weight to give the studies that found an association.

ACOG's advisory lists recurring problems in those studies, including reliance on mothers' own reports of what they took, little detail on dose and timing, and failure to control for genetic and family factors. ACOG says that of the studies in an August 2025 review, only two dealt adequately with genetic and family factors: a 2024 Swedish nationwide study and a 2021 Norwegian study, both comparing siblings. Both found no significant association once those factors were considered.

The MHRA describes the Swedish study as using registry data on 2.4 million children and comparing 185,909 children exposed to paracetamol in pregnancy with their own brothers and sisters who were not exposed. It found no evidence that paracetamol causes autism, and no sign that taking more of it raised the risk. The MHRA also points out that fever, infection and pain, the reasons people take paracetamol, are themselves risk factors for problems in pregnancy.

Why do doctors still treat fever and pain in pregnancy?

ACOG and the MHRA say that leaving fever and pain untreated carries its own risks for you and your baby. ACOG says fever in pregnancy has been associated with a higher risk of neural tube defects and other birth defects such as oral clefts and heart defects, and that poorly treated pain can destabilize the pregnant body, with possible effects on the fetus. The MHRA says pregnant women should not stop taking their pain medicines, because untreated pain and fever can pose risks to the unborn child. The FDA's letter adds that most short-term fevers in pregnant women do not require medication.

Can you take ibuprofen instead of Tylenol while pregnant?

Only if your doctor recommends it. ACOG says you should not take ibuprofen or naproxen in pregnancy unless your ob-gyn recommends them, for example for migraines that don't get better with acetaminophen, and then only in the second trimester and for 48 hours or less at a time. ACOG says it is not clear whether they are safe for a fetus in the first trimester, and that taking them in the third trimester may lead to birth defects.

The FDA's 2025 notice says ibuprofen has well-documented adverse impacts on the fetus. The MHRA tells patients not to swap paracetamol for ibuprofen, because NSAIDs such as ibuprofen are generally not recommended in pregnancy. For headaches, ACOG names acetaminophen as the best pain reliever in pregnancy; headaches during pregnancy covers what else helps.

When should you call your doctor or midwife?

• You have a severe headache, changes in your vision or pain in your upper belly. ACOG lists these among the signs of preeclampsia, which needs immediate medical attention.
• You have a fever. ACOG says fever in pregnancy raises the risk of neural tube defects, and recommends talking with your ob-gyn before taking acetaminophen for it.
• Pain or fever is not going away, or pain gets worse while you take an over-the-counter medicine. The MHRA and ACOG both say to get advice from your healthcare professional.
• You want to take ibuprofen, naproxen or any other pain medicine. ACOG says to talk with your ob-gyn before taking any over-the-counter medicine for pain or fever in pregnancy.