FDA: paracetamol rash should be discontinued Paracetamol (acetaminophen) is a commonly used antipyretic and analgesic drug, the U.S. Food and Drug Administration said in an August 1 alert that paracetamol can cause a rare but serious skin condition, and it is recommended that once a rash, skin blisters or more serious skin damage occurs when taking it, the drug should be discontinued for medical attention. Staff at the FDA’s Adverse Drug Reaction Reporting System looked at cases between 1969 and 2012 and found 107 cases related to paracetamol-induced skin disease in people of all ages, 67 hospitalizations and 12 deaths from skin disease. Adverse reactions to paracetamol can be fatal, mainly because it can cause Stevens-Johnson syndrome and toxic epidermolysis bullosa, two serious skin conditions manifested by rash, edema, and skin necrosis, with a high mortality rate. The FDA raised the warning level for adverse reactions to the highest level of black box warning for prescription drugs containing paracetamol and also advised patients that it is not possible to predict who is more likely to develop skin diseases after taking paracetamol and that patients are advised to strictly follow the medical advice and dosage instructions when taking such drugs. Once an adverse reaction such as a rash occurs, stop the drug immediately and seek medical attention and close observation.