Last month, former President Trump made a sweeping claim, unsupported by scientific evidence, that taking the pain reliever acetaminophen (Tylenol’s active ingredient) during pregnancy caused autism. This assertion lacked credible backing from studies.
However, for many years, medical professionals and researchers have consistently highlighted a very real and proven danger linked to acetaminophen: severe liver damage resulting from accidental overdose.
While experts confirm that acetaminophen is safe when used as directed, exceeding the recommended dosage, whether on purpose or by mistake, can lead to critical liver injury, necessitating hospitalization, a liver transplant, or even proving fatal.
Each year, several hundred individuals in the U.S. succumb to liver failure due to accidental acetaminophen poisoning. Medical researchers note that this often occurs when people, desperate for pain relief, inadvertently consume too much. Furthermore, acetaminophen is also involved in a number of suicides.
Despite the small percentage of users who overdose compared to the billions of doses consumed annually, acetaminophen remains the primary cause of acute liver failure in America.
Dr. Timothy Davern, a San Francisco-based liver specialist treating severe acetaminophen-induced liver injuries, stated, “I believe it’s a safely acceptable medication. However, if taken in excessive amounts, everyone is vulnerable to liver damage, and the repercussions can be catastrophic.”
Product labels for all Tylenol forms (pills or liquids) clearly state that “severe liver damage may occur” if the dosage exceeds four grams (4,000 milligrams) within a 24-hour period. For example, adults using Tylenol Extra Strength should not take more than eight tablets, as each contains 500 milligrams of acetaminophen. Labels also caution against using the drug daily if consuming three or more alcoholic beverages.
Mr. Trump’s recent warning amplified public scrutiny on Tylenol. Medical professionals widely condemned his remarks as irresponsible, emphasizing that the drug, a crucial option for pregnant women with fevers, is already prescribed cautiously.
Kenvue, the manufacturer of Tylenol, has consistently asserted the drug’s safety. They claim acetaminophen is the safest pain reliever for expectant mothers, advising them to always consult their physician before use.
Tylenol, available for seven decades, is the most recognized of approximately 600 acetaminophen-containing products. Roughly a quarter of American adults use acetaminophen weekly.
For decades, Johnson & Johnson marketed Tylenol. Under regulatory pressure, the company implemented numerous safety warnings and updates to combat overdoses. Almost every emergency room stocks an antidote, N-acetylcysteine (known as N.A.C.), which has been instrumental in saving lives from acetaminophen poisoning.
Despite these measures, accidental deaths, hospitalizations, and the need for liver transplants due to acetaminophen poisoning continue.
Over a 25-year period, nearly 3,900 individuals died from accidental acetaminophen poisoning, based on CDC death certificate data. Experts studying this issue consider this data, despite its imperfections, the most reliable estimate for unintentional acetaminophen-related fatalities.
Accidental acetaminophen deaths in the U.S.
Annual death certificate data shows a death toll of nearly 3,900 over 25 years. Experts said such deaths are almost exclusively from acetaminophen overdoses that lead to liver failure.
Data includes death certificates in which the primary cause of death listed was accidental poisoning from a category of 4-Aminophenol derivatives, by far the most common of which is acetaminophen.
Source: C.D.C. WONDER Multiple Causes of Death database
Rebecca Robbins/The New York Times
Many people inadvertently overdose on acetaminophen partly because they mistakenly believe this widely available over-the-counter drug is completely harmless.
Dr. Davern noted that the drug’s non-prescription status “lulls you into a false sense of security.” (It’s worth noting that in 2015, Dr. Davern testified as a paid expert witness in lawsuits alleging Tylenol-induced liver damage.)
Kenvue, the Johnson & Johnson spin-off responsible for Tylenol since 2023, maintains it actively works to educate consumers on proper product usage.
Kenvue spokeswoman, Melissa Witt, stated that both the current company and its predecessor have “studied this topic for decades,” emphasizing the critical importance for consumers to “read and follow product labels.”
Used as directed, acetaminophen is typically processed by the liver without issue. However, prolonged use at elevated doses can overwhelm the liver’s natural defenses, leading to the destruction of liver cells.
While excessive use of anti-inflammatory drugs like aspirin and ibuprofen rarely harms the liver, it can cause other severe issues such as gastrointestinal bleeding or kidney damage. Opioids, stronger pain relievers, come with their own distinct set of risks. The widespread adoption of acetaminophen is partly due to these alternative dangers.
The Pervasive Role of Pain in Overdoses
Dr. Richard Dart, who directs a poison center at Denver’s public hospital, has extensively researched the common traits among individuals who overdose on acetaminophen.
Dr. Dart emphasized, “The unifying element is pain.” He elaborated, “It’s frequently dental or lower back pain, or cases where individuals lack access to more potent pain relief, prompting them to overuse acetaminophen.”
He explained that in such distress, people often take multiple pills every few hours, losing track of the total dosage. The minuscule text on safety warnings doesn’t help. “When you’re in pain and suffering,” Dr. Dart observed, “you’re not carefully reading labels. You’re certainly not reaching for a magnifying glass.”
Dr. William Lee, a professor at the University of Texas Southwestern Medical Center in Dallas, shared a recent case: An elderly woman in her 70s, experiencing frequent falls and suspected bruised or fractured ribs, concealed her pain to maintain independence. She began taking Tylenol but failed to monitor her dosage or frequency, ultimately landing in the intensive care unit with severe liver damage, barely surviving.
He believes the product “probably needs stronger warnings.” (Years prior, Dr. Lee served as an unpaid expert witness for plaintiffs in Tylenol-related liver damage lawsuits.)
Individuals with alcohol use disorder are at higher risk for acetaminophen poisoning. Research indicates this is partly due to impaired judgment, leading to forgotten dosages. Additionally, heavy drinking can compromise liver health, increasing its vulnerability to acetaminophen-induced harm.
Dr. Dart confirmed that his research team has received ongoing funding from Johnson & Johnson and Kenvue to investigate acetaminophen’s liver risks, particularly its interaction with alcohol.
Remarkably, experts rarely encounter Tylenol poisoning in pregnant women, attributing this to their heightened caution regarding medication use.
Accidental overdoses typically involve gradually consuming excessive amounts of the drug over multiple days. Often, individuals remain unaware of the problem until liver damage is advanced, as early symptoms are minimal or absent. This lack of early warning can critically delay treatment, as the antidote must be administered quickly for maximum effectiveness.
Legal Battles and Their Mixed Outcomes
Over time, hundreds of lawsuits have been filed against Johnson & Johnson. Plaintiffs, comprising survivors of accidental Tylenol poisoning and the families of those who died, argued the company failed to adequately warn consumers about the drug’s liver risks.
A prominent case in the 1990s garnered national headlines. Antonio Benedi, then 37 and recently departed from his role as a White House aide, reportedly took Tylenol Extra Strength for several days while suffering from the flu and consuming little food. He subsequently fell into a coma, narrowly escaping death thanks to an emergency liver transplant.
Benedi’s lawsuit resulted in a jury ordering the company to pay him over $8 million. Now 70, he describes his life since losing his liver as “a rocky road,” marked by ongoing health struggles.
Kenvue refrained from commenting on Benedi’s case. In the 1990s, the company’s legal team maintained that Tylenol’s warnings were sufficient and that Benedi’s liver injury stemmed from a virus or other non-acetaminophen-related cause.
While the company has won other trials, Johnson & Johnson reached a confidential settlement with approximately 200 plaintiffs in 2017.
Details of the settlement, including any financial compensation or admission of fault, were not disclosed by either Kenvue or the plaintiffs’ legal representation.
If you or someone you know is struggling with thoughts of suicide, please reach out for help. You can call or text 988 to connect with the National Suicide Prevention Lifeline, or visit SpeakingOfSuicide.com/resources for more support. For those coping with the loss of a loved one to suicide, the American Foundation for Suicide Prevention provides valuable grief resources.
Research support provided by Susan C. Beachy.