Mint Explainer: What is Trump’s problem with paracetamol?

The administration has linked the use of Tylenol by pregnant women to an increased risk of autism in children, leading to widespread alarm and criticism globally. Medical and public health bodies have swiftly put out statements refuting the “unfounded" claims.

Tylenol is the brand name for acetaminophen or paracetamol. It is a non-opioid analgesic used to treat pain and fever, and is considered one of the safest drugs in the world if used in the correct dosage. It is also one of the few options available to pregnant women. It is “the first choice of painkiller if you're pregnant. It's commonly taken during pregnancy and does not harm your baby," the UK’s NHS says on its website. Mint explains the controversy.

What are Trump’s claims about Tylenol?

Trump’s administration has claimed that acetaminophen use in pregnant women, especially late in pregnancy, may cause long-term neurological effects in their children. ASD cases have surged nearly 400% in the US since 2000, and now affect one in 31 American children.

Trump on Monday advised pregnant women to “fight like hell not to take it" and that doctors in the US would be advised not to prescribe Tylenol to pregnant women. The US FDA will initiate a safety label change for acetaminophen (Tylenol and similar products) and the HHS will launch a nationwide public service campaign to inform families, the administration said in a press note.

Is there really a link between the drug and autism?

The administration cited large-scale cohort studies, including the Nurses’ Health Study II and the Boston Birth Cohort, which found associations between in-utero exposure and later diagnoses of ASD and ADHD. It also cited research by the dean of Harvard University’s Chan School of Public Health, which found a potential association.

The author said that more research was needed to confirm the findings, but recommended caution while using the drug in a statement. Health secretary RFK Jr has previously made links between vaccines and autism which have been debunked by experts.

What do experts say about Trump's claim?

The response to the announcement was swift. Several leading bodies, including the World Health Organization, the UK’s health regulator, MHRA, the European Medical Association, and health officials from Australia, Germany, and New Zealand, put out statements countering the claim. “I trust doctors over President Trump," UK health secretary Wes Streeting told reporters.

Health groups, such as the Society for Maternal-Fetal Medicine (SMFM) and the American College of Obstetricians and Gynecologists (ACOG), called the claims “highly concerning" and “irresponsible."

Experts said there was no conclusive evidence for the claims and cited studies, including a 2024 Swedish study of 2.4 million births, which used sibling data and found no link between in-utero paracetamol exposure and subsequent autism, ADHD or intellectual disability.

In fact, they cautioned that not treating high fevers in pregnant women can pose a risk to children. Other painkillers like aspirin and ibuprofen have well-documented adverse impacts on the foetus as well.

Is there a history to the controversy?

The issue goes back a few years to hundreds of lawsuits filed in 2022 against Tylenol marketer Kenvue, claiming links between Tylenol consumption during pregnancy and autism or ADHD. The suits were dismissed in 2023 after scientific evidence cited by the plaintiffs was deemed inadequate.

However, attorneys are planning to appeal it and are hoping for a government push, according to the Wall Street Journal. In fact, lead attorney Ashley Keller told Reuters earlier this month that he planned to alert the appellate court “if HHS follows through and does the right thing."

What is the scenario in India?

Paracetamol is sold as an OTC drug in India, under brand names like Dolo 650, Calpol and Crocin. The drug remains widely used, with Calpol (marketed by GSK) and Dolo (marketed by Micro Labs Ltd) clocking sales of ₹422 crore and ₹380 crore, respectively, as of August 2025 on a moving annual total basis.

However, concerns over its dosage have persisted. Last year, the Centre banned 156 fixed-dose drug combinations, including some with paracetamol, deemed ‘unsafe’. However, standalone paracetamol is not banned, the Centre clarified last month.