Acetaminophen, best known by the brand name Tylenol, is an ingredient in over 600 over-the-counter medicines. This has long been considered the safest choice for managing pain and fever during pregnancy. Recently, it made headlines after President Trump publicly spoke out against taking Tylenol during pregnancy and raised concerns about possible links to autism. The recent controversy has sparked debate between the medical community and governmental health agencies, and left expecting parents with more questions than answers. This episode unpacks the debate around acetaminophen and examines the available research on autism and other risks. Plus, hear guidelines to weigh the risks and benefits of treating symptoms versus letting them run their course so that you can make an informed decision for you and your baby.

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Why Pregnancy Changes the Equation with Medicines

We live in a time when medicines are readily available for nearly every discomfort. From headaches and fevers to allergies and stomachaches, there is a remedy available to treat them. Over-the-counter medications can feel like a simple solution when you are not feeling your best. Many of us rely on them without a second thought.

Pregnancy, however, is a unique and sensitive stage of life. Your body is working hard to support the growth and development of a baby. Even small exposures can sometimes have lasting effects. Because this is such a critical window of development, expecting mothers often exercise extra caution during this time. What feels routine outside of pregnancy suddenly carries more weight when another life is involved.

One of the biggest challenges is that there is a significant lack of research on how medications affect pregnancy. Studying drugs on pregnant women raises complex ethical and practical concerns. This means clinical trials often exclude pregnant women. As a result, much of the information we do have comes from observational studies or data collected after a medication has already been in use. This leaves many unanswered questions about which drugs are safe, which may pose risks, and where we need more evidence.

Safety of Over-the-counter Medications  

Over 80% of expectant mothers take an over-the-counter medication of some kind during their pregnancy. Nearly any label will state something to the effect of, “If pregnant or breastfeeding, ask a health professional before use.” Given the recent attention on acetaminophen, let’s examine the research on this drug and available alternatives.

Analgesics for Pain Relief and Fever

Analgesics are pain relievers and include NSAIDs (nonsteroidal anti-inflammatory drugs) and acetaminophen. These are also antipyretics, which are medicines that reduce fever. Analgesics treat minor aches and pains, reduce a fever, or may be present in combination medicines to treat colds or other symptoms. Let’s examine the main types of pain relievers available over the counter.

NSAIDs (nonsteroidal anti-inflammatory drugs)

NSAIDs include aspirin and ibuprofen. Both are pain relievers, anti-inflammatory agents (reducing swelling and inflammation), and antipyretics (reducing fever).

Aspirin

Doctors generally advise against aspirin during pregnancy as a pain reliever and fever reducer. The risks of taking aspirin during pregnancy vary depending on the stage of pregnancy. During the first trimester, aspirin poses a concern for pregnancy loss and congenital disabilities. During the third trimester, the risk of the premature closure of a vessel in the fetus’s heart increases. Use of high-dose aspirin for long periods in pregnancy also increases the risk of bleeding in the brain of premature infants.

One thing that sets aspirin apart from other NSAIDs is its antiplatelet effect, which reduces blood clotting. There is evidence that low-dose aspirin may reduce the risk of preeclampsia. A meta-analysis found that low-dose aspirin in high-risk pregnancies is associated with a decrease in the rate of preeclampsia by approximately 10%. Low-dose aspirin comes in 81 mg tablets, compared to a standard tablet containing 325mg. The American College of Obstetricians and Gynecologists supports the use of low-dose aspirin for the purpose of preventing preclampsia for those with risk factors. If a doctor prescribes low-dose aspirin, it should start between 12 and 16 weeks daily until delivery only .

Ibuprofen  

Ibuprofen is also usually not recommended during pregnancy. There is evidence that ibuprofen can increase your risk for miscarriage early in your pregnancy. The FDA recommends pregnant mothers avoid ibuprofen after 20 weeks because it can result in low amniotic fluid.

Acetaminophen

Due to the risks associated with aspirin and ibuprofen, acetaminophen has been the primary recommendation for a pain reliever or fever reducer during pregnancy. As a result, up to 65% of pregnant mothers reported using acetaminophen at least once during their pregnancy. You may know acetaminophen by the brand names Paracetamol or Tylenol. More than 600 over-the-counter medications include this drug as an active ingredient, including many cold medicines.

When To Treat vs When To Wait

Any decision to take a medication during pregnancy involves weighing risks and benefits. This should also include the risks of the symptoms going untreated. You may be able to manage a cold or headache without taking medication, with no adverse effects on your baby. However, the risks change with a fever.

Fevers During Pregnancy

A fever is not a sickness on its own, but rather a side effect of another illness or condition. Usually, it is part of your body’s immune response as a natural defense against infection. Many diseases, from mild infections to more serious issues like appendicitis, can cause a fever. The Centers for Disease Control and Prevention and the American College of Obstetricians and Gynecologists define a fever as a body temperature of 100.4°F or 38.0 °C. 

Studies on Fever and Pregnancy Risks

A review and meta-analysis that included 46 studies found maternal fever was associated with neural tube defects, oral clefts, and congenital heart defects. Overall, they did not find an association between maternal fever and miscarriage, stillbirth, or preterm birth. Eight studies showed a protective effect of using an antipyretic medication to reduce fever. Two studies showed an increased risk with the use of an antipyretic. There were some conflicting results among the studies on whether you should use medication to reduce fever.

One study suggested a link between maternal fever in pregnancy and an increased risk of autism. This study noted that 20% of pregnant women experience at least one fever during their pregnancy. The headlines in articles about this study stated that fever increased the risk for ASD by 34% or even more for women who had three or more fevers after the first trimester. Before you panic, consider both relative and absolute risks. That 34% or more increase is relative. The absolute risk in this study of a child having autism went from .6% overall to .7%. Yes, it is an increase. If you get a fever, it does not mean that your child will have ASD. Overall, this study may show a correlation, but it does not show causation.

There is still so much we do not know about how fevers can affect a baby in utero. There are no universal guidelines on what temperature or length of a fever is harmful. We do not know exactly what impact a fever could have. It depends on when or how long it occurs. A significant difference exists between running a fever of 100.4°F (38°C) for an hour and 103°F (39.4°C) for a day or longer. There are many questions that scientists are still working to answer. 

Given what we know about the risks of fever during pregnancy and that acetaminophen is the safest antipyretic, it has long been the medication of choice for reducing fever during pregnancy.

The Acetaminophen Debate

Recently, President Trump raised concerns when he cautioned pregnant women not to take Tylenol (acetaminophen) because of links to autism. He mentioned that since 2000, rates of autism have gone from 1 in 20,000 to 1 in 10,000 to now 1 in 31, and 1 in 12 boys. He stated, “Effective immediately, the FDA will be notifying physicians that the use of acetaminophen, which is commonly known as Tylenol, during pregnancy can be associated with a very increased risk of autism. So taking Tylenol is not good. For this reason, they are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary, for instance, in cases of extremely high fever.” He went on to say, “You shouldn’t take it. All pregnant women should talk to their doctors for more information on limiting the use of this medication.”

Robert F. Kennedy, Jr. also joined President Trump. RFK said they “ordered HHS to launch an unprecedented all-agency effort to identify all causes of autism, including toxic and pharmaceutical exposures.” You can watch a video of Trump and RFK, Jr. here.

What is Autism?

Autism spectrum disorder (ASD) encompasses a wide range of conditions marked by difficulties with social skills, repetitive behaviors, speech, and nonverbal communication. It affects 1 in 31 children and is 3.4 times more common among boys. Remember that this is a spectrum disorder, so there are likely many contributing factors, including environmental exposures and genetics.

Research Linking Acetaminophen and Autism

The research referred to by Trump is not new. In fact, I have addressed this on the Pregnancy Podcast as far back as 2017. A review of nine separate studies found that acetaminophen use during pregnancy is associated with adverse neurodevelopment, including ADHD, autism spectrum disorder, and lower IQ. In one study, researchers related an increased risk for asthma in children to maternal use of acetaminophen during pregnancy. Another study found an association between acetaminophen use during pregnancy and behavioral problems in children.

The 2021 Consensus Statement

In 2021, 91 scientists, clinicians, and public health officials released a consensus statement cautioning against using acetaminophen during pregnancy. They examined many studies on both humans and animals. They found the use of acetaminophen might alter fetal development, which could, in turn, increase the risks of certain neurodevelopmental, reproductive, and urogenital disorders. The professionals behind this statement called for agencies like the FDA and obstetric and gynecological societies (like ACOG) to review the evidence and reevaluate the risks of this drug.

ACOG’s 2021 Response

Days after this consensus statement cautioning against the use of acetaminophen, ACOG released a statement. “This consensus statement, and studies that have been conducted in the past, show no clear evidence that proves a direct relationship between the prudent use of acetaminophen during any trimester and fetal developmental issues.” ACOG goes on to say, “ACOG’s clinical guidance remains the same, and physicians should not change clinical practice until definitive prospective research is done. Most importantly, patients should not be frightened away from the many benefits of acetaminophen. However, as always, any medication taken during pregnancy should be used only as needed, in moderation, and after the pregnant patient has consulted with their doctor.”  

The 2025 FDA Notice

In light of the recent initiatives from Trump, the FDA has issued a notice to physicians on the use of acetaminophen during pregnancy. It states, “In recent years, evidence has accumulated suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and ADHD in children. Some studies have described that the risk may be most pronounced when acetaminophen is taken chronically throughout pregnancy to childbirth. These concerns may be magnified by the fact that a very young child’s liver may still be developing, and thus a child’s ability to metabolize the drug may be limited.

To be clear, while an association between acetaminophen and autism has been described in many studies, a causal relationship has not been established, and there are contrary studies in the scientific literature. The association is an ongoing area of scientific debate, and clinicians should be aware of the issue in their clinical decision-making, especially given that most short-term fevers in pregnant women and young children do not require medication.

In the spirit of patient safety and prudent medicine, clinicians should consider minimizing the use of acetaminophen during pregnancy for routine low-grade fevers. This consideration should also be balanced with the fact that acetaminophen is the safest over-the-counter alternative in pregnancy among all analgesics and antipyretics; aspirin and ibuprofen have well-documented adverse impacts on the fetus.”

ACOG’s 2025 Response

The president of ACOG responded with a statement affirming the safety and benefits of acetaminophen during pregnancy. “In more than two decades of research on the use of acetaminophen in pregnancy, not a single reputable study has successfully concluded that the use of acetaminophen in any trimester of pregnancy causes neurodevelopmental disorders in children. In fact, the two highest-quality studies on this subject—one of which was published in JAMA last year—found no significant associations between use of acetaminophen during pregnancy and children’s risk of autism, ADHD, or intellectual disability.”

The statement went on to say, “Acetaminophen is one of the few options available to pregnant patients to treat pain and fever, which can be harmful to pregnant people when left untreated. Maternal fever, headaches as an early sign of preeclampsia, and pain are all managed with the therapeutic use of acetaminophen, making acetaminophen essential to the people who need it. The conditions people use acetaminophen to treat during pregnancy are far more dangerous than any theoretical risks and can create severe morbidity and mortality for the pregnant person and the fetus.”

What We Know and the Latest Developments

Given the research we have, there are valid concerns about acetaminophen use and autism. Remember that autism is a spectrum disorder and it is not monocausal, meaning there is not one cause. It is likely the result of many environmental and genetic factors. The research we have on acetaminophen during pregnancy does not show a causal relationship. While we do not have proof that prenatal acetaminophen use causes autism, there is evidence to raise concerns. There is an urge to conduct more investigation into both autism and acetaminophen. Hopefully, we will see more research in the future.

In the meantime, we can see that there is some disagreement between governmental health organizations and physician organizations. As a result of the mixed messaging, care providers may have differing opinions on the safety of acetaminophen during pregnancy. Some physicians may be more cautious about their pregnant patients taking acetaminophen. Some doctors may restrict use to longer-lasting or higher fevers, rather than short-term low-grade fevers or minor aches and pains. You should discuss this with your doctor or midwife to get their recommendation.

Guidelines for Safer Medication Use in Pregnancy

According to the CDC, about 9 in 10 women report taking some type of medicine during pregnancy. About 7 in 10 report taking at least one prescription medicine. Fewer than 10% of medicines approved since 1980 have enough information to determine their safety during pregnancy. This is because pregnant women are often excluded from studies that determine the safety of new medicines. As a result, women and healthcare professionals have limited information to make informed treatment decisions during pregnancy. Let’s go through some guidelines you can use to help determine whether you want to take an over-the-counter medicine.

Treat the Underlying Cause

You should also try to address the underlying causes, rather than just treating the symptoms. If you frequently experience back pain during pregnancy, it may seem easiest to take a pain reliever whenever it bothers you. However, if the cause is poor posture or sleeping in an uncomfortable position, you should address the underlying issue, not only masking the pain with medication.

Start with the Least Invasive Option

If you have symptoms that you can manage with lifestyle changes, that should be the first line of defense. For example, suppose you have a headache due to dehydration. In that case, ensuring you drink enough water may help prevent them, rather than relying on taking pain medication every time a headache occurs. Consider using the least invasive methods first and increasing the treatment with varying levels of medicines if necessary.

Take Extra Caution in the First Trimester

The first trimester is the most sensitive period for fetal development. This is when your baby’s major organs and body systems are forming. The first trimester is also when the risk of miscarriage is at its highest. Because significant development is occurring in these early weeks, even minor exposures may have a greater impact than they would later in pregnancy. For this reason, many care providers and expectant parents are more cautious about medications during the first trimester.

Use the Lowest Dose for the Shortest Time

When you do need to take a medication, it is best to use the lowest effective dose for the shortest amount of time. Extra-strength or long-lasting versions usually contain higher amounts of the drug, which means greater exposure. The same applies to combination medicines that treat multiple symptoms simultaneously. You may expose yourself and your baby to unnecessary ingredients. Whenever possible, choose a drug that targets only the specific symptom you are dealing with. Also avoid taking it longer than you truly need to. There is a difference between taking something occasionally and using it regularly. Taking acetaminophen once or twice to treat a high fever is different from using it regularly to manage aches and pains. If you can reduce the dose or the frequency, you also reduce the potential risks.

Weighing the Risks and Benefits

There are no perfect double-blind, placebo-controlled studies that can definitively confirm a medication is 100% safe during pregnancy. This is why every decision comes down to weighing the potential risks and benefits. Relief from pain, fever, or other symptoms may be significant for your health and your baby’s health, but so is minimizing unnecessary exposure.

Talking to Your Doctor or Midwife

if it is available over-the-counter. If you get a fever during pregnancy, consult with your care provider. It is also a good idea to proactively discuss fevers and get their recommendation on when to use acetaminophen and when to let a fever run its course. This is one of the reasons it is so crucial for you to have a doctor or midwife whom you respect and trust. They are your trusted partner throughout your prenatal care and birth and can help you navigate challenging decisions like these.

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