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What to Know About Unverified Links Between Acetaminophen and Autism

When used appropriately, acetaminophen is safe for pregnant women and their unborn babies, says CU Anschutz developmental pediatrician Sandra Friedman, MD, MPH.

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by Kara Mason | September 25, 2025
Photo of pregnant woman holding a white pain reliever pill.

Top U.S. officials from the Trump administration this week warned the use of acetaminophen, the active ingredient in Tylenol, during pregnancy may cause neurological conditions, such as autism and ADHD, in children — however, research studies do not support or verify those claims.

“Extensive research has shown that the cause of autism is very complex, involving genetics, often interacting with environmental factors,” says Sandra Friedman, MD, MPH, professor of pediatrics at the University of Colorado Anschutz School of Medicine. “There is no single cause, and no single definitive treatment.”

Acetaminophen is commonly used as a pain reliever and used to treat low-grade fevers. It’s been deemed safe for use in pregnant individuals.

Studies — including one published in JAMA last year — have found no significant associations between acetaminophen use during pregnancy and children’s risk of autism or other intellectual disabilities.

A widely-cited scientific article by Harvard epidemiologists — which only reviewed existing literature and did not conduct original analysis — recently concluded there may be a link between acetaminophen use during pregnancy and neurodevelopmental disorders, but review authors say more research is needed to determine a causal relationship.

“While there have been observational studies showing an association between use of acetaminophen and some neurodevelopmental conditions, including autism, there are other influences to consider such as genetic factors or underlying illness,” Friedman says. “Research has not shown a definitive causal relationship between use of acetaminophen and autism. It is important to underscore that autism is not caused by what parents do.”

We spoke with Friedman, who also works as director of JFK Partners, a CU Anschutz program that focuses on providing care to people with developmental disabilities and special health care needs, to learn more about autism diagnosis and whether common over the counter medicines, like Tylenol, have an impact on health and child development.

Q&A Header

What do researchers know about the causes of autism?

Hundreds of genes — as many as more than 1,000 — have been associated with autism. There is a high heritability rate, with genetics factors being the primary cause. Some of the genetic factors may be inherited and some may be due to spontaneous changes in the genes. There also may be interactions between genetics and environmental factors during critical times in the developing brain.

Are there recommendations for pregnant individuals on how to limit the risk of their child developing autism or other neurological conditions?

Autism cannot be prevented, per se. It is important for pregnant women to receive good prenatal care throughout the pregnancy for their well-being and that of the fetus, following recommendations for a healthy pregnancy.

There are factors that may increase the risk of autism and other neurodevelopmental disabilities, such as certain medications, alcohol and other exposures, and some prenatal infections. Guidance for healthy pregnancies should routinely be provided by women’s medical providers.

The U.S. Food and Drug Administration advises physicians to exercise caution on medicines like Tylenol that contain acetaminophen. How are pregnant individuals currently directed to take these over-the-counter drugs and what makes them an effective treatment?

Acetaminophen, or brand name Tylenol, has been used for many years by pregnant women to treat symptoms, such as fever, which may cause harm to the fetus. As with any over-the-counter or prescribed medication, risk-to-benefit ratio needs to be considered. It is important for pregnant women to follow the advice of their medical providers with regards to treatment for specific symptoms. Acetaminophen is also safe to give to children when following correct dosages and frequencies.

The American College of Obstetrics and Gynecology (ACOG), American Academy of Pediatrics (AAP), the Society for Developmental and Behavioral Pediatric, and other disability-related organizations have all issued similar statements regarding the safety of acetaminophen during pregnancy.

Can other common pain relievers that don’t contain acetaminophen, like aspirin and ibuprofen, have adverse effects of pregnancy and the fetus?

Ibuprofen and full-dose aspirin, or non-steroidal anti-inflammatories, are not recommended as being safe during pregnancy because of risks to the fetus and the pregnancy. An ACOG statement issued this month correctly states that “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 FDA also announced its intent to approve leucovorin calcium tablets for treating cerebral folate deficiency (CFD) and autism symptoms. What is this treatment and what does the research say?

Leucovorin, or folinic acid, may be prescribed to reduce side effects of chemotherapy.

Folinic acid and folate are forms of vitamin B9. Studies have shown that folate taken during pregnancy may help lower the risk a later diagnosis with autism or other disabilities.

Pregnant women already are advised to take folate during pregnancy. However, research on treatment of children with autism with folate and evaluation for folate antibodies are limited and of variable quality. There is the need for good evidence-based studies to evaluate the effects of this therapy. Treatment with leucovorin therefore is not recommended as a standard treatment.

What are some early indicators that a child may have autism and what should parents know about seeking care?

Early signs of autism may be seen in infants and toddlers. Areas evaluated focus on reduced social communication and the presence of repetitive behaviors and restricted interests.

During infancy, some babies with autism may display reduced smiling, eye contact, and/or sound imitation. There may be reduced babbling and back-and-forth sound and syllable production, and lack of response to name. There also may be reduction in pointing, following of a point with eye gaze, shared interactions and enjoyment with a parent or caregiver.

It always is important to document normal hearing acuity, even in the presence of a normal neonatal hearing test. Young children with autism generally have delays in both nonverbal and verbal communication, with reduced use of gestures. Words may be used to label although not for communication. Children also may echo language rather than spontaneously produce language. Repetitive behaviors like hand-flapping also may be seen. Approximately 25% of children with autism may stop using words they previously produced and withdraw socially, generally occurring between 15 to 30 months of age. The AAP recommends developmental and behavioral screening for all children at nine, 18, and 30 months and autism screening for all children at 18 and 24 months. Earlier identification and diagnosis are important to be able to provide children with the services and supports they need as early as possible.

It is important that all autistic individuals and those with other developmental disabilities are valued and not cast in negative stereotypes that undermines who they are and the contributions they make to society. There also is need for rigorous approaches and well-designed studies from which evidence-based recommendations may be made.

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Sandra Friedman, MD, MPH