President Trump went far beyond the science when, based on an unproven link and inconclusive studies, he warned last month that taking the pain reliever acetaminophen, the active ingredient in Tylenol, during pregnancy caused autism.
But for decades, doctors and scientists have sounded an alarm about a different risk associated with acetaminophen products that is well established: liver damage from accidentally overdosing on the drug.
Experts emphasize that acetaminophen is safe when taken as directed. But when people take too much, either intentionally or unintentionally, it can cause such serious injury to the liver that it can lead to hospitalization, a liver transplant or even death.
Every year, a few hundred Americans die from liver failure from unintentionally taking too much acetaminophen, often because, while struggling with pain, they lose track of how much they have taken, according to medical researchers. Suicides involving acetaminophen account for additional deaths.
Relative to the number of people who take acetaminophen, the number of overdoses is very small. But because billions of doses of the drug are taken by Americans each year, acetaminophen overdoses are nevertheless the leading cause of acute liver failure.
“I think it’s an acceptably safe medication,” said Dr. Timothy Davern, a liver specialist in San Francisco who treats people with severe liver injury or acute liver failure from acetaminophen poisoning. “But if it’s used in higher doses, we’re all susceptible to liver injury from that. The consequences can be devastating.”
The labels of all Tylenol products, which are usually taken as pills or liquids, say that “severe liver damage may occur” if users take too much: more than four grams — or 4,000 milligrams — in 24 hours. For Tylenol Extra Strength for adults, that would be more than eight tablets: Each tablet contains 500 milligrams of acetaminophen. The label also warns people against taking the drug if they consume at least three alcoholic drinks “every day while using this product.”
Public attention on Tylenol soared after Mr. Trump’s warning. Many doctors viewed the president’s words as reckless, and said that the drug, one of few options for pregnant women with high fevers, was already used sparingly.
Kenvue, the maker of Tylenol, has repeatedly defended the drug’s safety. It said that acetaminophen was the safest pain relief option for pregnant women, but added that they should consult their doctors before taking it.
Tylenol has been on the market for 70 years and is the best known among some 600 products containing acetaminophen. Each week, nearly a quarter of U.S. adults use acetaminophen.
Johnson & Johnson sold Tylenol for decades. Over the years, and often under pressure from U.S. regulators, the company has issued a series of safety warnings and updates to try to prevent overdoses. Nearly all emergency departments stock an antidote to acetaminophen poisoning — nicknamed N.A.C. for its chemical name, N-acetylcysteine — that has saved countless lives.
But unintentional deaths, hospitalizations and the need for liver transplants persist.
Nearly 3,900 people died from unintentional acetaminophen poisoning over 25 years, according to death certificate data tracked by the Centers for Disease Control and Prevention. Experts who have studied the issue said the C.D.C. data, while imperfect, was the best estimate of accidental deaths primarily involving acetaminophen.
People sometimes take too much acetaminophen in part because they perceive the drug, which is readily accessible on the shelves of most American supermarkets and drugstores, to be harmless.
“You’re lulled into a false sense of security because it’s not a prescription drug,” Dr. Davern said. (In 2015, Dr. Davern was a paid expert witness for plaintiffs in lawsuits claiming liver damage from Tylenol.)
Kenvue, the Johnson & Johnson spinoff company that has made Tylenol since 2023, said it has tried to help people use the product appropriately.
Melissa Witt, a spokeswoman for Kenvue, said the company and its predecessor “have studied this topic for decades.” She also said it was “important for consumers to read and follow product labels.”
When acetaminophen is taken as directed, the liver generally metabolizes it without a problem. But at higher levels taken over sustained periods, the drug can overwhelm the body’s defenses and kill liver cells.
Anti-inflammatory drugs like aspirin and ibuprofen taken in excess almost never cause liver damage, but they can cause other serious side effects, like gastrointestinal bleeding or kidney damage. Stronger painkillers, like opioids, have their own dangers. These problems are part of why acetaminophen became so widely used.
‘The common factor is pain’
Dr. Richard Dart has been studying the characteristics of people who overdose on acetaminophen for years as the director of a poison center at Denver’s public hospital.
“The common factor is pain,” Dr. Dart said. “It’s often dental pain or low back pain, or people who can’t get access to stronger pain medicines, so they take too much acetaminophen.”
People in these situations, he said, often take a handful of pills every few hours and lose track of the count. The small print used in safety warnings on pill bottles does not help. “When you’ve got pain, and you’re suffering, you’re not reading labels carefully,” Dr. Dart said. “You’re not getting your magnifying glass out, for sure.”
Dr. William Lee, a professor at the University of Texas Southwestern Medical Center in Dallas, recounted a case he recently heard about: A woman in her 70s had been falling frequently and appeared to have bruised or cracked a few ribs, but told no one for fear of losing her independence. She started taking Tylenol to relieve her pain, but did not keep track of how much she was taking or how often. She wound up in the intensive care unit with liver damage and nearly died, Dr. Lee said.
“I think it probably does need stronger warnings,” he said. (Years ago, Dr. Lee was an expert witness on behalf of plaintiffs in lawsuits claiming liver damage from Tylenol. He said he was not paid for that work, at his request.)
People who abuse alcohol are more likely to experience acetaminophen poisoning. Some research suggests that this is driven at least partly by behaviors like losing track of how many pills were taken because of intoxication. People who drink heavily may also damage their liver, making it more susceptible to injuries from acetaminophen.
For years, Dr. Dart said, his research group has received funding from Johnson & Johnson and Kenvue to study acetaminophen’s risks to the liver, including work on the association with alcohol.
Experts said they virtually never see pregnant women with Tylenol poisoning, because the women tend to be extra cautious about taking medicine.
The accidental overdoses generally involve steadily taking too much of the drug over several days. People often don’t know there is a problem until the liver damage is already severe, because there are often few or no early symptoms. That can dangerously delay treatment because the antidote must be given promptly to take full effect.
Mixed results from legal claims
Over the years, hundreds of plaintiffs have sued Johnson & Johnson, saying that the company had not done enough to warn users of Tylenol’s liver danger. The plaintiffs are people claiming that they survived accidental Tylenol poisonings or families of people who died.
In the 1990s, one high-profile case received national attention. Antonio Benedi, a 37-year-old who had just left his job as a White House aide at the end of President George H.W. Bush’s term, took Tylenol Extra Strength for a few days while sick with the flu and barely eating, he said. He fell into a coma, nearly died and received an emergency liver transplant.
Mr. Benedi sued, and a jury ordered the company to pay him more than $8 million. Now 70, he said he has struggled with years of health problems stemming from losing his liver. “It’s been a rocky road,” he said.
Kenvue declined to comment on Mr. Benedi’s case. In the 1990s, the company’s lawyers argued that its Tylenol warnings were adequate and that a virus or something else unrelated to acetaminophen caused Mr. Benedi’s liver injury.
The company has prevailed in other cases that have gone to trial. But in 2017, Johnson & Johnson reached a confidential settlement with about 200 plaintiffs.
Neither Kenvue nor the plaintiffs’ lawyers would say whether the settlement involved cash payments to the families or any admission of wrongdoing by the company.
If you are having thoughts of suicide, call or text 988 to reach the National Suicide Prevention Lifeline or go to SpeakingOfSuicide.com/resources for a list of additional resources. If you are someone living with loss, the American Foundation for Suicide Prevention offers grief support.
Susan C. Beachy contributed research.
Rebecca Robbins is a Times reporter covering the pharmaceutical industry. She has been reporting on health and medicine since 2015.
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