Tylenol, which is made and sold by Johnson & Johnson, is one of the most popular painkillers available over the counter. It is also used to reduce fevers associated with colds, the flu, and other infections. Tylenol is also found in some prescription medications, but as an over the counter drug, it accounts for billions of doses of medication taken each year.

While Tylenol is widely used and is considered to be mostly safe and effective for people of all age groups, this medication also has some serious possible risks. Overdosing on Tylenol is a leading cause of liver damage and liver failure. The U.S. Food and Drug Administration (FDA) considers is a major public health problem and over the years has issued several warnings and changed the labeling requirements to try to protect the public. In spite of the warnings, people have suffered and are suing Johnson & Johnson for damages.

What is Tylenol?

Tylenol is an over the counter drug that is found in many different formulations. It is also found in prescription formulations. Tylenol is made by McNeil Laboratories, which is a subsidiary of Johnson & Johnson. The generic name for the active ingredient in Tylenol is acetaminophen, sometimes also called paracetamol. In 2008, Americans took nearly 25 million doses of acetaminophen to treat pain and reduce fever.

McNeil and Johnson & Johnson market Tylenol as a safe and effective painkiller and fever reducer, and as a safer option than similar drugs like aspirin and ibuprofen. These other medications have been associated with stomach upset and stomach bleeding. Thanks to its effectiveness and relative safety, Tylenol generates around $1 billion in revenue every year.

Acetaminophen Formulations

Tylenol comes in many different formulations, and all of them contain acetaminophen. There is extra strength Tylenol, Children’s Tylenol Plus Cold, Tylenol Cold Sore Throat, Tylenol PM, Tylenol Cold Multi-Symptom Daytime, and many others. Johnson & Johnson makes all the Tylenol products, but there are many other brands that contain acetaminophen. These include Actifed, Coricidin, Midol, Sinutab, Dayquil, Anacin, Cepacol, Panadol, Theraflu, Triaminic, Zicam, and also store-brand medications.

Prescription drugs that contain acetaminophen include Percocet, Vicodin, Ultracet, Tapano, Hydrocet, Endocet, Phenaphen, Tylox, Sedapap, and Tylenol with codeine. Because acetaminophen treats both pain and fever, you may find it in formulations labeled for colds, the flu, headaches, arthritis pain, and many other conditions.

How it Works

Acetaminophen belongs to two different classes of drugs. As an analgesic, it relieves pain, and as an antipyretic, it also reduces fever. It is not fully understood how acetaminophen works as a pain killer, but it may be that as an analgesic it raises the threshold of pain by inhibiting receptors in the brain related to the sensation of pain.

A fever is a side effect of inflammation, the body’s immune response to an infection. Part of the inflammation process involves the formation of pro-inflammatory compounds called prostaglandins. Acetaminophen blocks the formation of one of these, called prostaglandin E. This, in turn, lowers the overall temperature of the body and reduces the fever.

Although it can lower the body’s temperature and reduce fever, acetaminophen doesn’t actually treat or reduce inflammation. Other over the counter painkillers, like ibuprofen, treat pain by reducing inflammation at the site of the pain, while acetaminophen blocks pain signals in the brain.

Tylenol and Liver Damage

Most people tolerate Tylenol well and do not experience side effects. However, at doses higher than what is recommended, acetaminophen can cause liver damage and even liver failure. When you take Tylenol, small amounts of the acetaminophen are converted into a compound that is toxic. This toxic compound binds to cells in the liver and causes damage and injury.

In normal doses, the amount of toxic compound produced is minimal and not harmful. It is an amount that the liver can safely handle and remove it. The more acetaminophen is taken, the more toxic compound is produced and the less able the liver is to process and remove it from the body. Too much acetaminophen leads to damage to the liver.

According to the FDA, acetaminophen was the leading cause of liver failure in the U.S. between 1998 and 2003. Nearly half of those acute liver failure cases recorded that were related to acetaminophen occurred when someone accidentally overdosed on the medication. Per year, there are around 56,000 emergency room visits and 458 deaths caused by liver failure from acetaminophen.

Liver damage or liver failure caused by acetaminophen may be worsened or may happen at lower doses if the person taking it drinks three or more alcoholic beverages per day or has or has ever had liver disease. The labeling on acetaminophen, as required by the FDA, states that no one should take more than 4,000 milligrams of it per day. Even a small amount of acetaminophen over what is recommended can damage the liver, and makes an overdose, which can be fatal, possible.

Why is Liver Damage from Acetaminophen so Common?

If you take acetaminophen and Tylenol products as directed, there is little risk of liver damage. Why then are so many cases of liver damage and failure caused by this medication? According to the FDA, there are several reasons. One is that the safety margin is small. For some people, just a little bit too much can be problematic.

Another reason is that there are so many products out there that contain acetaminophen. Someone who has a cold or chronic pain may take several medications, not realizing how much acetaminophen they are actually taking in per day. Also, the signs of liver damage early on are hard to detect. You may do damage to your liver, but not realize it right away and in the meantime continue to take more acetaminophen.

FDA Warnings

The FDA has taken several steps to educate the public, issue warnings, and reduce the amount of liver damage done by Tylenol and other acetaminophen products. The FDA first included the alcohol warning in 1998, initiated an advisory committee to produce warnings in 2002, and began a public education campaign in 2004.

The FDA also tacked the prescription painkillers that include acetaminophen. In 2011 the group required that these drugs, like Vicodin and Percocet, include no more than 325 milligrams of acetaminophen per capsule. The FDA also requires that these products have a black box warning to inform patients of the risks of liver damage.

Skin Reactions

Liver damage and failure are among the most serious possible consequences of using acetaminophen incorrectly, but there are also some rare skin conditions that may occur. The FDA warned about these in 2013. Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis are all possible with Tylenol use. They are very rare, but the first two are deadly. Signs of these serious conditions include a rash, blistering, changes in skin pigment, scars, blindness, and flu-like symptoms.

Recalls

In addition to the dangerous risks associated with taking acetaminophen, Tylenol has also seen a number of recalls over the years. Between 2009 and 2012, several lots had to be recalled for being contaminated with a dangerous chemical that caused vomiting and diarrhea. An infant formulation was also recalled for having a dosing system that could cause babies to get too much or too little of the medicine. Recalls were extensive enough that the FDA stepped in to monitor factories and ensure adequate quality control.

Lawsuits

Several lawsuits have been filed against McNeill and Johnson & Johnson because of the dangers of Tylenol. For example, one individual sued after taking a Tylenol product as directed for just a few days. She had to go to the emergency room where she got the diagnosis of liver failure caused by acetaminophen and then required weeks to recover. The plaintiff accused the drug maker of failing to adequately warn of the risks.

In another tragic case, a family sued Johnson & Johnson after their son, just one year old, died from liver failure. They had been giving him an infant’s formula of Tylenol. The courts awarded $5 million to the family for the tragedy. If you have experienced liver damage from Tylenol products and feel that you were not fully warned of the risks before taking the medication, you may also have a valid case against the drug manufacturer.