On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label under the Active Ingredient(s) section. Acetaminophen is an ingredient in many over-the-counter (OTC) and prescription medicines.Acetaminophen is available alone in single-ingredient products and also combined with other medicines in products used to treat colds, coughs, allergies, pain, and sleeplessness.
#Side effect of tylenol arthritis skin
FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of OTC acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the same.įDA has prepared a list of questions and answers to provide more information about this safety issue.Īdditional Information for Patients and Consumers long-term use), and the long period of time that the drug has been on the market however it is likely that these events (i.e., SJS, TEN, and AGEP) occur rarely.įDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. It is difficult to determine how frequently serious skin reactions occur with acetaminophen, due to the widespread use of the drug, differences in usage among individuals (e.g., occasional vs. This new information resulted from the Agency’s review of the FDA Adverse Event Reporting System (FAERS) database and the medical literature 1-20 to evaluate cases of serious skin reactions associated with acetaminophen (see Data Summary). Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions.
#Side effect of tylenol arthritis professional
Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers. Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.Īnyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen.
Acetaminophen is a common active ingredient to treat pain and reduce fever it is included in many prescription and over-the-counter (OTC) products. These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions.
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