US President Donald Trump has sparked a controversy yet again, this time by linking a common over-the-counter pain reliever, Tylenol, to autism.
In a press conference and on social media, Trump claimed
that taking Tylenol during pregnancy may cause autism in children, urging pregnant women to avoid the drug “unless absolutely necessary”.
The US President on Monday announced that the Food and Drug Administration will be notifying physicians that the use of acetaminophen during pregnancy “can be associated with a very increased risk of autism”. “They are strongly recommending that women limit Tylenol (Acetaminophen is Tylenol’s active ingredient) use during pregnancy unless medically necessary,” such as to treat fever, “if you can’t tough it out,” Trump said in the Oval Office alongside Health Secretary Robert F Kennedy Jr.
Let’s take a look at what Tylenol is, the autism claims, and how doctors have responded.
What is Tylenol?
Tylenol is a widely used brand of the drug acetaminophen, which is also referred to as paracetamol in countries like the UK and India. It’s commonly taken to ease pain and bring down fever.
Easily available without a prescription, Tylenol is generally viewed as safe for broad use. During pregnancy, it’s often suggested as a preferred option over medications such as ibuprofen, which may pose higher risks during specific stages of pregnancy.
Acetaminophen has been used by millions of pregnant women worldwide for decades. It’s typically advised for occasional use, particularly for fevers, which themselves can pose a risk to foetal development.
What is Autism?
Formally known as Autism Spectrum Disorder (ASD), it is a neurodevelopmental condition that affects how a person communicates, interacts socially, and experiences the world. It is called a “spectrum” because it includes a wide range of strengths and challenges, which can vary greatly from one individual to another.
The core features of autism generally fall into two categories: Social Communication and Interaction Differences and Restricted and Repetitive Behaviours.
What Does Scientific Evidence Say?
Some observational studies in the past decade have suggested a potential association between prenatal acetaminophen use and increased risk of autism spectrum disorder (ASD). However, experts emphasise that correlation is not causation.
For instance, a 2019 meta-analysis published in JAMA Psychiatry noted a small increase in autism diagnoses among children whose mothers reported acetaminophen use during pregnancy. However, researchers highlighted that confounding factors, such as the reason the medication was taken (e.g., fever, infection, inflammation), could explain the association.
More recently, a 2024 study in Sweden, which followed 2.5 million children, found no increased risk of autism, ADHD, or intellectual disability when comparing siblings whose mothers did and did not take acetaminophen during pregnancy. This type of sibling-comparison design is considered more rigorous, as it controls for genetic and environmental variables.
However, there is no strong evidence that acetaminophen use during pregnancy causes autism. The most rigorous studies (especially those using sibling comparisons) do not find elevated risk once familial confounders are controlled.
Some studies show modest associations, particularly for subtypes of autism (for instance with hyperactivity symptoms), or with long duration of use, but these findings are not definitive and are subject to many limitations.
What Do Doctors Say?
Medical and regulatory bodies generally consider acetaminophen safe for use in pregnancy when needed, especially since untreated fever or pain also carry risks.
According to the American College of Obstetricians and Gynecologists (ACOG) and Centers for Disease Control and Prevention (CDC), acetaminophen is still regarded as a safe and effective medication when used in moderation during pregnancy.
Speaking to CNN-News18, Dr Jayashree Sundar, gynaecologist and obstetrician for 30 years at Rainbow Children’s Hospital & Rosewalk Hospital, said there is no direct link or causative link between paracetamol and autism. “Just because the US President has made this remark, the panic button should not be pushed. There is no Indian study to show any such findings till now. I have an experience of 30 years and I have prescribed paracetamol to my pregnant patients as painkillers for joint pains. If my patient has 103 degree fever, it can affect the baby so it is better to take paracetamol to bring down the fever. That being said, over-the-counter medication in pregnancy should be avoided.”
What Has Kenvue Said?
Kenvue, the company that owns the Tylenol brand after its spinoff from Johnson & Johnson, has firmly rejected Trump’s claims.
In a statement, Kenvue said: “We strongly disagree with any suggestion that acetaminophen causes autism. The totality of the scientific evidence does not support this claim.”
The company also warned that misleading statements could lead to public health risks, if pregnant women are dissuaded from taking appropriate medical action. Internal reports suggest that Kenvue’s executives, including interim CEO Kirk Perry, had previously met with Trump allies and even Robert F Kennedy Jr to express concerns over promoting this theory.
According to a Wall Street Journal report, Kenvue attempted to prevent the inclusion of Tylenol in an RFK Jr-backed report linking consumer products to developmental disorders.