The FDA has issued a warning saying that acetaminophen, the active ingredient in Tylenol, ibuprofen, Excedrin, Nyquil and many other prescription and over-the-counter pain medications, could potentially lead to Stevens Johnson Syndrome (SJS), a life-threatening skin rash. 

In a drug safety communication issued in August 2013, the FDA said it will require that this SJS warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. The agency will also request that manufacturers of OTC acetaminophen drug products add a warning, but only when they are marketed under a new drug application. The announcement has led to a number of SJS lawsuits accusing drug makers of failing to adequately disclose this risk on the warning labels of these drugs.

What is Stevens Johnson Syndrome

Stevens Johnson Syndrome is a very serious, potentially life-threatening reaction to a medication or ingredient in medication. SJS symptoms typically begin with red or purplish rashes on the skin and develop into severe blistering, causing the skin to burn from the inside out. Sometimes the infected skin will even shed itself. It can also affect the mucous membranes of the body, such as the mouth, eyes and genitals.

SJS symptoms require immediate medical attention and can take a few weeks up to several months to properly heal. If SJS was caused by a medication or medication ingredient, the drug will have to be permanently avoided.

When the SJS skin rash covers more than 30% of the body, the diagnosis changes to Toxic Epidermal Necrolysis (TEN). TEN is more dangerous, causing more skin to peel off in larger quantities. SJS and TEN open the possibility of secondary skin or blood infection, blindness, internal organ damage, or even death. While about 5%-15% of SJS patients die, the statistic changes to 30%-40% in TEN patients.

Common Acetaminophen Products

Acetaminophen is the most common drug ingredient in America. More than 600 OTC and prescription medications contain acetaminophen, including generic and store brand pain relievers, fever reducers, and sleep aids as well as cough, cold, and allergy medicines. (Source: KnowYourDose.org.)

Due to the widespread use of acetaminophen products, the FDA said it is difficult to determine how frequently serious skin reactions like Stevens Johnson Syndrome occur. The following acetaminophen products list contains some — but not all — of the common medications containing the ingredient. Consumers who took one of these drugs and were diagnosed with Stevens Johnson Syndrome may be eligible to join a free SJS lawsuit investigation and pursue compensation for their medical bills, pain and suffering, and other damages.

Actifed®
Alka-Seltzer Plus Liquid Gels®
Anacin®
Cepacol®
Contac®
Coricidin®
Dayquil®
Dimetapp®
Dristan®
Excedrin®
Feverall®
Formula 44®
Goody’s® Powders
Liquiprin®
Midol®
Nyquil®
Panadol®
Robitussin®
Saint Joseph® Aspirin-Free
Singlet®
Sinutab®
Sudafed®
Theraflu®
Triaminic®
TYLENOL® Brand Products
Vanquish®
Vicks®
Zicam®Common Prescription Acetaminophen Products

Butalbital
Endocet®
Fioricet®
Hycotab
Hydrocet®
Hydrocodone Bitartrate
Lortab®
Oxycodone
Percocet®
Phenaphen®
Sedapap®
Tapanol®
Tramadol
Tylenol® with Codeine
Tylox®
Ultracet®
Vicodin®
Zydone®

–Additional Reporting by Sarah Mirando