Kenvue Brands LLC, the maker of Tylenol®, issued the following statement related to unfounded claims that taking acetaminophen causes autism:
Nothing is more important to us than the health and safety of the people who use our products. We believe independent, sound science clearly shows that taking acetaminophen does not cause autism. We strongly disagree with allegations that it does and are deeply concerned about the health risks and confusion this poses for expecting mothers and parents.
The Bottom Line
- Does acetaminophen (also known as paracetamol) cause autism or ASD? No. Current scientific evidence does not support a causal relationship.
- Do leading medical authorities recommend acetaminophen during pregnancy when medically indicated and used as directed? Yes.
- Has Kenvue changed its safety guidance? No. Pregnant women should follow the label and consult a healthcare professional before taking acetaminophen or any over-the-counter medication.
What Science Shows
We have continuously evaluated the relevant science and there is no credible data that shows a proven link between taking acetaminophen and autism. Rigorous, independent research, endorsed by leading medical professionals and global health regulators, confirms this, and trusted health professionals agree.
Here is the context behind that conclusion:
- Causation vs. association: Observational findings can be influenced by “confounding by indication” including the underlying condition (e.g., fever, infection or pain) that acetaminophen is taken for.
- Totality of scientific evidence: Across the available data, the weight of evidence does not establish that taking acetaminophen during pregnancy causes autism.
- Clinical experience: Major maternal health and obstetric groups consider acetaminophen an appropriate first-line treatment option during pregnancy when used as directed and clinically indicated.
When science gets sidelined, people’s health is put at risk. High fevers and pain, for example, are widely recognized as potential risks to a pregnancy if left untreated. Acetaminophen is the safest pain reliever option for pregnant women as needed throughout their entire pregnancy and without it, women face dangerous choices: suffer through conditions like fever that are potentially harmful to both mom and baby or use riskier alternatives.
Acetaminophen is also one of the most widely studied pain relievers and fever reducers in infants and children, and numerous randomized, controlled clinical trials support the safety of acetaminophen in infants and children when used as directed.
What Health Authorities Say
We stand with the many public health and medical professionals who have reviewed this science and agree. This includes the World Health Organization, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the Autism Science Foundation, the American Academy of Pediatrics, Health Canada, the Society of Obstetricians and Gynaecologists of Canada, and others.
Legal Claims Lack Merit and Scientific Support
When it comes to any pending or potential legal claims related to this topic, science matters. We believe there is a deliberate distortion of the facts being driven by plaintiffs’ attorneys attempting to revive legal claims that have already been thrown out of federal court.
Additionally, recent media characterizations of documents produced in litigation omit critical context and do not reflect the full record.
Legal Record to Date:
California state case (Davey, May 2025): A California judge in May 2025 reviewed all the relevant materials, including our company documents, and recognized that we acted responsibly and demonstrated “positive corporate behavior.” The case was ultimately dismissed, with the court finding no credible causal link between acetaminophen and autism:
“… that a company that makes pharmaceuticals regularly reviews the literature potentially relevant to the safety of its products and supports candid internal discussion, however, is positive corporate behavior. While these discussions show awareness of the science, they do not change the state of that science.”
- Federal multi-district litigation (In re: Acetaminophen ASD-ADHD Product Liability Litigation, December 2023): In dismissing the federal multi-district litigation in December 2023, the judge in that case made clear that the experts supporting these false claims used a flawed and biased approach, picking data that fit their argument while ignoring the weaknesses in the evidence.
We believe we will continue to be successful in litigation as the claims lack legal merit and scientific support.
Safety Guidance
To be clear: our full guidance on the safe use of Tylenol® has not changed. Our products are safe and effective when used as directed on the product label, and we recommend pregnant women do not take any over-the-counter medication, including acetaminophen, without talking to their doctor first. Healthcare professionals – not lawyers – are best positioned to advise their patients on whether taking acetaminophen is appropriate based on their patient’s unique medical conditions.
Our Commitment
We stand with science. We will continue to monitor emerging research, engage with regulators and medical societies, and ensure that our product labels provide clear guidance and reflect the best available scientific data.
We will continue to explore all options to protect the health interests of women and children.
Cautions Concerning Forward-Looking Statements
This statement contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, litigation related to acetaminophen. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kenvue Brands LLC and its affiliates.
A list and descriptions of risks, uncertainties and other factors can be found in Kenvue Inc.’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 29, 2024 and subsequent Quarterly Reports on Form 10-Q and other filings, available at www.kenvue.com or on request. Kenvue Brands LLC and its affiliates undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or developments or otherwise.