Tylenol (Acetaminophen)

Tylenol is a popular pain reliever and fever reducer. It’s the brand name for a medication called acetaminophen, which is also known as paracetamol. You can buy Tylenol without a prescription, and it’s often found in over-the-counter products, such as cold medicines. It’s also available in some prescription medications, such as the painkillers Percocet and Vicodin.

Tylenol reduces pain by altering the way your body senses pain, and it lowers fever by regulating your body’s temperature. Unlike some other pain relievers, like ibuprofen, which includes Advil and Motrin, Tylenol doesn’t help with inflammation.

Kenvue, a spin-off of Johnson & Johnson, makes Tylenol. Kenvue became a stand-alone company in 2023.

Tylenol’s Known Risks and Side Effects

Tylenol’s label carries warnings about possible liver damage and allergic or skin reactions. You should be careful not to take more than 4,000 milligrams of acetaminophen within 24 hours.

As of March 31, 2025, the U.S. Food and Drug Administration had received 30,099 reports of adverse events associated with Tylenol. Of those, 15,225 were categorized as serious, including 2,033 deaths.

You should stop taking Tylenol and seek immediate medical attention if you experience severe side effects.

If you suspect acetaminophen caused you an unusual problem, even if it’s not on this list, consider talking to your doctor.

Acetaminophen overdose ranks as the second leading reason for liver transplants around the world. In the United States, it is the top cause of liver failure. Each year, acetaminophen poisoning leads to about 56,000 visits to emergency rooms and causes 2,600 hospitalizations, resulting in approximately 500 deaths annually.

About half of these poisonings happen accidentally, often because people misunderstand the dosing instructions or use multiple acetaminophen-containing products at once.

“Liver damage from acetaminophen is particularly dangerous because it often develops silently until it reaches a critical stage,” Dr. John Abroon, a board-certified internist and primary care physician, told Drugwatch.

He said this means patients will often show up at emergency rooms with already severe liver damage.

“Despite being preventable with proper use, acetaminophen overdose remains a leading cause of acute liver failure due to factors like lack of public awareness, misuse and the drug’s widespread availability,” Dr. Abroon said.

You might exceed the safe limit for acetaminophen if you don’t follow the label instructions or if you use more than one product that contains it. Be cautious not to exceed 4,000 milligrams per day. If you’re using different acetaminophen products, you can ask your doctor or pharmacist for help with tracking the total amount.

Studies have suggested an association between Tylenol use during pregnancy and a higher risk for autism and ADHD (attention deficit/hyperactivity disorder).

A 2022 study in PLoS One found that children whose mothers used acetaminophen during pregnancy were more likely to have attention and sleep problems at age three. These links remained even after accounting for stress during pregnancy, suggesting a possible connection worth further study.

A 2019 study by Johns Hopkins Researchers published in JAMA found that higher levels of acetaminophen in newborns’ umbilical cord blood were linked to a greater risk of ADHD and autism spectrum disorder (ASD) in childhood. The risk increased with higher exposure levels, suggesting a possible dose-response relationship that needs more study.

The FDA has examined research on whether Tylenol use during pregnancy could be linked to ADHD or autism in children. They found the studies to be too limited to change the agency’s advice. The FDA recommends that pregnant women carefully consider any medications and consult their doctor before taking acetaminophen or other pain relievers. Although the announcement dates back to 2015, it remains the agency’s current stance.

Tylenol Lawsuits Claim It Caused ADHD & Autism

In 2022, a federal panel consolidated 65 Tylenol lawsuits from around the United States into a multidistrict litigation (MDL) in the United States District Court for the Southern District of New York. MDLs enable the consolidation of similar lawsuits into a single litigation to expedite the legal process.

The lawsuits claimed mothers who took over-the-counter acetaminophen during pregnancy may have an increased risk of their children developing ASD or ADHD.

At one time, over 600 lawsuits were filed in the MDL. The lawsuits targeted large retail pharmacies including CVS, Walgreens and Walmart.

The court granted Johnson & Johnson’s requests to exclude particular expert testimonies from the plaintiffs. The judge ruled that without these witnesses, the plaintiffs had no admissible evidence to support their claims.

As a result, individual lawsuits were sent back to the various courts where they were initially filed. However, attorneys have filed an appeal to reinstate expert witnesses and may still be accepting Tylenol cases.

If you believe you or your child experienced severe side effects or injury from acetaminophen, there are four steps you can take to protect your or your child’s health.

How To File a Tylenol Lawsuit

If you believe you or your children have been harmed by prenatal acetaminophen exposure, you may qualify to file a lawsuit. Your case is especially likely to qualify if there is a diagnosis of autism spectrum disorder or attention deficit hyperactivity disorder involved.

If you’re thinking about filing a lawsuit due to problems related to Tylenol, you can receive a complimentary case evaluation from Drugwatch. Just complete a brief form, and a member of our team will reach out to discuss your experience and determine if you have a viable case.

Our evaluations are completely free with no obligation to proceed. You’ll receive helpful information and support no matter what you choose.

Drugwatch collaborates with reputable law firms that focus on personal injury and hazardous drug cases. Our goal is to connect you with a lawyer who is familiar with your specific circumstances.

Make sure to gather your medical records in advance so you can reference them if necessary. Moreover, it’s essential to act promptly because legal time limits differ from state to state.