Product information for raltegravir updated to warn of Stevens Johnson syndrome and hypersensitivity reaction

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Product information for the HIV integrase inhibitor raltegravir (Isentress) has been updated in the US.

The “Warnings and Precautions” section now cautions that rare cases of Stevens-Johnson syndrome, a severe and potentially life-threatening skin reaction, have been associated with the drug, as have hypersensitivity reactions.

The updated product information was released by the Food and Drug Administration on November 2nd.



A rash is an area of irritated or swollen skin, affecting its colour, appearance, or texture. It may be localised in one part of the body or affect all the skin. Rashes are usually caused by inflammation of the skin, which can have many causes, including an allergic reaction to a medicine.


When using a diagnostic test, the probability that a person who does have a medical condition will receive the correct test result (i.e. positive). 


Being sick.



A group of symptoms and diseases that together are characteristic of a specific condition. AIDS is the characteristic syndrome of HIV.



The feeling that one is about to vomit.

Patients are advised to contact their doctor immediately if they develop a rash.

Individuals should stop taking raltegravir at once and seek medical attention if this rash is accompanied by any of the following symptoms:

  • Fever.

  • Feeling generally unwell.

  • Extreme tiredness.

  • Aching in muscles or joints.

  • Blistering.

  • Mouth ulcers or lesions.

  • Inflammation of the eyes.

  • Swelling of the eyes, lips or mouth.

  • Facial swelling.

  • Breathing difficulties.

  • Yellowing of the skin or eyes.

  • Dark urine.

  • Pale stools.

  • Nausea.

  • Vomiting.

  • Loss of appetite.

  • Pain, aching or sensitivity on the right hand side, below the ribs.

Individuals experiencing these symptoms will be closely monitored and appropriate therapy will be initiated if necessary.

The revised product information can be read here.