FDA has issued a Consumer Update that warns of rare but serious skin reactions that may occur in patients taking acetaminophen. These complications include three serious skin diseases: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP). SJS and TEN can both be fatal, and usually require hospitalization. Patients suffering from AGEP commonly recover within a few weeks after they stop taking the medication that caused the problem.

Symptoms of these conditions include skin rashes, blisters, and widespread damage to the surface of the skin. Patients taking acetaminophen or other compounds that contain acetaminophen should be advised to stop taking the medication if they experience such symptoms and should consult their health care providers or seek an emergency department immediately.

FDA emphasizes that this information should be viewed within the context of millions of patients who, over generations, have used and benefited from acetaminophen and stresses that severe allergic skin reactions are an extremely rare condition. Further, the agency notes that many medications can cause allergic reactions, and skin allergy warnings have already been added to the drug labels of other categories of over-the-counter analgesics including ibuprofen and naproxen. “This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to use other medications,” said Sharon Hertz, MD, deputy director of FDA’s Division of Anesthesia, Analgesia, and Addiction Products, “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious side effects, which are potentially fatal.”