What do national and international health organizations say about the link between Tylenol (acetaminophen) use and autism?

Background

The White House under the Trump Administration has emphasized growing evidence of a possible link between Tylenol (acetaminophen) use during pregnancy and an increased risk of autism in children.1 In recent statements made in September 2025, officials framed this as part of a broader effort to address rising autism rates. Citing large-scale cohort studies, as well as a 2021 international consensus statement advising pregnant women to limit acetaminophen use by taking the smallest necessary dose for the briefest duration possible, the administration highlighted that prenatal acetaminophen exposure may affect fetal brain development.2-5 President Donald Trump and his team positioned this guidance as a public health measure aimed at better understanding and reducing the neurological risks associated with acetaminophen use during pregnancy.

The White House also announced a series of actions to address what it called the nation’s ‘autism epidemic’, highlighting both treatment advances and new safety guidance.6 President Donald Trump and Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. introduced initiatives that include the Food and Drug Administration (FDA) recognition of leucovorin as the first approved therapy for speech-related symptoms in children with autism linked to cerebral folate deficiency, expanded Medicaid coverage for this treatment, and new National Institutes of Health (NIH) research to validate its safety and effectiveness.

At the same time, the administration directed the FDA to issue new safety labeling for acetaminophen and launch a public awareness campaign in response to studies suggesting a possible association between acetaminophen use during pregnancy and neurodevelopmental disorders like autism and attention-deficit/hyperactivity disorder (ADHD).7 The FDA Commissioner , Dr. Marty Makary, stated that while the agency wants parents and doctors to be aware of this evidence, decisions about use should remain individualized. The FDA acknowledged that several large studies, including the Nurses’ Health Study II and the Boston Birth Cohort, have found an association between prenatal acetaminophen exposure and later neurodevelopmental diagnoses, particularly with prolonged use. However, the agency emphasized that no causal relationship has been proven and that acetaminophen remains the safest option for treating fever during pregnancy, since untreated high fevers and alternatives like aspirin or ibuprofen carry known fetal risks.

What Are Health Organization Guidance Statements Regarding These Claims?

The World Health Organization
The World Health Organization (WHO), made up of 194 member nations, is led by a Director-General elected by those nations.8 With a global team of more than 8,000 professionals, including doctors, scientists, epidemiologists, and public health experts, WHO works to coordinate international responses to health emergencies, prevent disease, promote well-being, and expand access to care. Through collaboration with countries and partners, the organization uses scientific evidence to help ensure that all people have the opportunity to live safe and healthy lives.

WHO states that there is no conclusive scientific evidence linking acetaminophen (paracetamol) use during pregnancy to autism.9 While numerous large-scale studies have explored this potential association, findings have been inconsistent, and the causes of autism remain multifactorial and not fully understood. WHO advises pregnant women to use any medication cautiously and only under medical supervision, especially in early pregnancy. The organization also reaffirmed that vaccines do not cause autism, citing decades of rigorous global research confirming their safety and effectiveness. WHO emphasizes the importance of maintaining evidence-based childhood immunization schedules, which have saved millions of lives, and continues to prioritize understanding and supporting individuals with autism and their families through global collaboration and advocacy free from stigma.

American College of Obstetricians and Gynecologists
The American College of Obstetricians and Gynecologists (ACOG) is the leading professional organization for obstetricians and gynecologists, representing more than 62,000 members across the Americas.10 For nearly 75 years, ACOG has advanced equitable, evidence-based care through expert-reviewed guidelines, professional education, and advocacy. Its members, including physicians, residents, and students, are dedicated to delivering high-quality, respectful care supported by science. ACOG also provides trusted patient education through its Every Stage Health platform, empowering individuals to make informed health decisions.

Dr. Steven J. Fleischman, president of ACOG, strongly criticized recent federal claims suggesting a link between acetaminophen use in pregnancy and autism, calling them scientifically unfounded and misleading.11 He states that “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”, and high-quality studies, including one published in the Journal of the American Medical Association, found no significant association with autism, ADHD, or intellectual disability.11,12 Fleischman noted that studies claiming such links often suffer from major methodological flaws, such as unreliable data and lack of control for confounding factors. He stressed that acetaminophen remains one of the few safe and essential options for treating pain and fever during pregnancy, conditions that can pose serious health risks to both mother and baby if untreated. ACOG continues to affirm that, when used as directed, acetaminophen plays a safe and important role in maternal care and offers a frequently asked questions webpage on acetaminophen use in pregnancy.

American Academy of Pediatrics
The American Academy of Pediatrics (AAP) is a professional organization dedicated to promoting the physical, mental, and social health of infants, children, adolescents, and young adults.13 Founded in 1930, the AAP was established as an independent forum to advocate for children’s unique developmental and medical needs at a time when pediatric care was still emerging as a distinct field. What began as a small group of physicians has grown into a community of more than 67,000 pediatricians working to advance evidence-based care, support pediatric professionals, and ensure that every child has the opportunity to achieve optimal health and well-being.

The AAP emphasizes that acetaminophen (Tylenol or paracetamol) is a safe and effective over-the-counter medication for reducing fever and relieving pain in children when used as directed.14 The organization rejects claims linking acetaminophen use to autism, calling the claims misleading and potentially harmful to parents and autistic individuals. Extensive research shows no causal relationship between acetaminophen use in children or during pregnancy and autism, ADHD, or intellectual disability, and there is no single known cause of autism, which likely arises from multiple genetic and environmental factors. The AAP advises parents to follow dosing guidelines carefully, consult their pediatrician with any concerns, and avoid giving more than 4 doses in 24 hours or combining products containing acetaminophen. It also supports guidance from ACOG that occasional, directed use of acetaminophen during pregnancy is safe.

Society for Maternal-Fetal Medicine
The Society for Maternal-Fetal Medicine (SMFM) is a U.S based professional organization of over 6,500 members dedicated to improving and ensuring equitable outcomes for all pregnancies, particularly those considered high-risk.15 Representing physicians, researchers, and healthcare professionals specializing in maternal-fetal medicine, SMFM advances evidence-based care through education, research, and advocacy. The organization provides extensive professional development opportunities, supports cutting-edge research, and focuses on reducing maternal health disparities, preventing maternal mortality, and safeguarding access to comprehensive reproductive health care.

In response to the White House announcement on acetaminophen use during pregnancy, the SMFM reaffirmed that acetaminophen remains a safe and appropriate option for treating pain and fever in pregnant individuals.16 The organization emphasized that, while some studies have explored a possible link between prenatal acetaminophen use and conditions like autism or ADHD, the research does not establish a causal connection. The SMFM continues to stand by its evidence-based guidance that acetaminophen use during pregnancy has not been shown to increase the risk of autism or other neurodevelopmental disorders in children, and it supports ongoing, rigorous research involving pregnant patients to better understand the causes of such conditions.

Conclusion

While the Trump Administration has advanced claims of a possible link between acetaminophen use during pregnancy and autism, major health organizations (including the WHO, ACOG, the AAP, and the SMFM) unanimously emphasize that current scientific evidence does not support a causal relationship. These organizations continue to affirm that acetaminophen, when used as directed, remains one of the safest options for managing fever and pain during pregnancy. They caution that misinformation may create unnecessary fear and lead to the avoidance of necessary treatment, potentially endangering both maternal and fetal health. Collectively, their statements underscore the importance of relying on high-quality, peer-reviewed research and professional medical guidance when making healthcare decisions during pregnancy.

References

  1. The White House. FACT: Evidence suggests link between acetaminophen, autism. The White House. Published September 22, 2025. Accessed October 19, 2025. https://www.whitehouse.gov/articles/2025/09/fact-evidence-suggests-link-between-acetaminophen-autism/
  2. Liew Z, Kioumourtzoglou MA, Roberts AL, O’Reilly ÉJ, Ascherio A, Weisskopf MG. Use of Negative Control Exposure Analysis to Evaluate Confounding: An Example of Acetaminophen Exposure and Attention-Deficit/Hyperactivity Disorder in Nurses’ Health Study II. Am J Epidemiol. 2019;188(4):768-775. doi:10.1093/aje/kwy288
  3. Prada D, Ritz B, Bauer AZ, Baccarelli AA. Evaluation of the evidence on acetaminophen use and neurodevelopmental disorders using the Navigation Guide methodology. Environ Health. 2025;24(1):56. Published 2025 Aug 14. doi:10.1186/s12940-025-01208-0
  4. Ji Y, Azuine RE, Zhang Y, et al. Association of Cord Plasma Biomarkers of In Utero Acetaminophen Exposure With Risk of Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder in Childhood. JAMA Psychiatry. 2020;77(2):180-189. doi:10.1001/jamapsychiatry.2019.3259
  5. Bauer AZ, Swan SH, Kriebel D, et al. Paracetamol use during pregnancy – a call for precautionary action. Nat Rev Endocrinol. 2021;17(12):757-766. doi:10.1038/s41574-021-00553-7
  6. The White House. President Trump, Secretary Kennedy Announce Bold Actions to Tackle Autism Epidemic. Published September 22, 2025. Accessed October 20, 2025. https://www.hhs.gov/press-room/hhs-trump-kennedy-autism-initiatives-leucovorin-tylenol-research-2025.html
  7. Office of the Commissioner. FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy. U.S. Food And Drug Administration. Published September 22, 2025. Accessed October 19, 2025. https://www.fda.gov/news-events/press-announcements/fda-responds-evidence-possible-association-between-autism-and-acetaminophen-use-during-pregnancy
  8. World Health Organization: WHO. Who we are. Accessed October 20, 2025. https://www.who.int/about/who-we-are
  9. World Health Organization: WHO. WHO statement on autism-related issues. Published September 24, 2025. Accessed October 20, 2025. https://www.who.int/news/item/24-09-2025-who-statement-on-autism-related-issues.
  10. American College of Obstetricians and Gynecologists. About. Accessed October 21, 2025. https://www.acog.org/about
  11. American College of Obstetricians and Gynecologists. ACOG affirms safety benefits acetaminophen pregnancy. Published September 22, 2025. Accessed October 21, 2025. https://www.acog.org/news/news-releases/2025/09/acog-affirms-safety-benefits-acetaminophen-pregnancy
  12. Ahlqvist VH, Sjöqvist H, Dalman C, et al. Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability. JAMA. 2024;331(14):1205-1214. doi:10.1001/jama.2024.3172
  13. About the AAP. Aap.org. Published 2020. Accessed October 21, 2025. https://www.aap.org/en/about-the-aap/?srsltid=AfmBOooDR5PLL2DOx4B1ypHKl7RVZHdpWc6g_XL9AKDyixB36cEMK393
  14. Acetaminophen is safe for children when taken as directed, no link to autism. Home. Published September 30, 2025. Accessed October 21, 2025. https://www.aap.org/en/news-room/fact-checked/acetaminophen-is-safe-for-children-when-taken-as-directed-no-link-to-autism/?srsltid=AfmBOoojiCIEb5txXwmS5tlty8jAW-7NflDOMNLHU7FO0GvaV4iXMpTt.
  15. Society for Maternal-Fetal Medicine. Mission & Vision. Accessed October 21, 2025. https://www.smfm.org/mission-and-vision
  16. Society for Maternal-Fetal Medicine. SMFM Response to Administration announcement on acetaminophen use during pregnancy and Autism. Accessed October 21, 2025. https://www.smfm.org/news/smfm-response-to-administration-announcement-on-acetaminophen-use-during-pregnancy-and-autism

Prepared by:
Faria Munir, PharmD, MS, BCPS
Clinical Assistant Professor, Drug Information Specialist
University of Illinois at Chicago Retzky College of Pharmacy

November 2025

The information presented is current as October 21, 2025. This information is intended as an educational piece and should not be used as the sole source for clinical decision-making.