Possible side effects with EDURANT^®

EDURANT^® can cause serious side effects including

• Severe skin rash and allergic reactions. Skin rash is a common side effect of EDURANT^®. Skin rash can be serious. Call your healthcare professional right away if you get a rash. In some cases, rash and allergic reaction may need to be treated in a hospital

If you get a rash with any of the following symptoms, stop taking EDURANT^® and get medical help right away:

• fever
• tiredness
• difficulty breathing or swallowing
• skin blisters
• swelling of the face, lips, mouth, tongue or throat
• generally ill feeling
• muscle or joint aches
• blisters or mouth sores
• redness or swelling of the eyes (conjunctivitis)
• Liver problems. People with a history of hepatitis B or C virus infection or who have certain liver function test changes may have an increased risk of developing new or worsening liver problems during treatment with EDURANT^®. Liver problems have also happened during treatment with EDURANT^® in people without a history of liver disease. Your healthcare professional may need to do tests to check your liver enzymes before and during treatment with EDURANT^®. Call your healthcare professional right away if you develop any of the following signs or symptoms of liver problems:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • light-colored stools (bowel movements)
  • loss of appetite
  • dark or tea-colored urine
  • pain, aching, or tenderness on the right side of the stomach area
  • nausea or vomiting
• Depression or mood changes. Tell your healthcare professional right away if you have any of the following symptoms:
  • feeling sad or hopeless
  • feeling anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself
• Changes in body fat can happen in people who take HIV medicine. These changes may include 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
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare professional right away if you start having any new symptoms after starting your HIV-1 medicine

The most common side effects of EDURANT^® include depression, headache, trouble sleeping (insomnia), and rash.

This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-332-1088. You may also report side effects to Janssen Products, LP, at 1-800-JANSSEN (1-800-526-7736).