Understand possible INTELENCE®
side effects

It’s important to understand the possible side effects you may experience when taking INTELENCE® (etravirine) with other HIV medicines. While many side effects can be managed, some are more serious than others.

About INTELENCE®

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How to take INTELENCE®

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Patient Information

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Side Effects

INTELENCE® can cause serious side effects including:

  • Severe skin rash and allergic reactions. Skin rash is a common side effect of INTELENCE®. The risk of getting a skin rash is higher in females. Rarely, rash can be severe and may lead to death. Severe skin rash with blisters or peeling skin, including the area around the mouth or eyes, may happen more frequently in children less than 18 years of age who take INTELENCE® in combination with other HIV-1 medicines than in adults. Call your healthcare provider right away if a rash develops; severe cases may need to be treated in a hospital.
  • If you get a rash with any of the following symptoms, stop taking INTELENCE® and call your healthcare provider or get medical help right away:
    • Fever
    • Generally ill feeling
    • Extreme tiredness
    • Muscle or joint aches
    • Blisters or sores in mouth
    • Blisters or peeling of the skin
    • Redness or swelling of the eyes
    • Swelling of the mouth, lips, or face
    • Problems breathing
  • Sometimes allergic reactions can affect body organs, such as your liver. Call your healthcare provider right away if you have any of the following signs or symptoms of liver problems:
    • yellowing of your skin or whites of your eyes
    • dark or tea colored urine
    • pale colored stools (bowel movements)
    • nausea or vomiting
    • loss of appetite
    • pain, aching, or tenderness on the right side of your stomach area
  • As with other HIV medicines, INTELENCE® may cause side effects, including:
    • Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Call your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicines.
    • Changes in body fat can happen in people taking HIV-1 medicines. These changes may include an increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk). Loss of fat from the legs, arms, and face may also happen. The exact cause and long-term health effects of these problems are not known.
  • The most common side effects of INTELENCE® in adults include rash as well as numbness, tingling or pain in the hands or feet.
  • The most common side effects of INTELENCE® in children include rash and diarrhea.

These are not all the possible side effects of INTELENCE®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare provider right away. Do not stop taking INTELENCE® or any other medications without first talking to your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see additional Important Safety Information below.

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