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If you develop a rash with any of the following symptoms, stop using ISENTRESS and contact your doctor right away: fever, generally ill feeling, extreme tiredness, muscle or joint aches, blisters or sores in mouth, blisters or peeling of skin, redness or swelling of the eyes, swelling of the mouth or face, problems breathing. Sometimes allergic reactions can affect body organs, such as your liver. Call your doctor 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/vomiting, loss of appetite, pain, aching or tenderness on the right side of your stomach area. 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. Tell your doctor right away if you start having new symptoms after starting your HIV-1 medicine. People taking ISENTRESS may still develop infections or other conditions associated with HIV infections. The most common side effects of ISENTRESS include: trouble sleeping, headache, dizziness, nausea and tiredness. Less common side effects include: depression, hepatitis, genital herpes, herpes zoster including shingles, kidney failure, kidney stones, indigestion or stomach area pain, vomiting, suicidal thoughts and actions, and weakness. Tell your doctor before you take ISENTRESS if you have a history of muscle disorders called rhabdomyolysis or myopathy or increased levels of creatine kinase in your blood. ISENTRESS Chewable Tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with phenylketonuria. Tell your doctor right away if you get unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This may be a sign of a rare but serious muscle problem that can lead to kidney problems. These are not all the possible side effects of ISENTRESS. For more information, ask your doctor or pharmacist. Tell your doctor if you have any side effect that bothers you or that does not go away. Tell your doctor about all your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breastfeed because their babies could be infected with HIV through their breast milk. Tell your doctor about all the medicines you take, including: prescription medicines like rifampin (a medicine commonly used to treat tuberculosis), over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take any of these medicines: rifampin (Rifadin, Rifamate, Rifater, Rimactane), an antacid medicine that contains aluminum or magnesium, a cholesterol lowering medicine (statin), a medicine that contains fenofibrate (Antara, Lipofen, Tricor, Trilipix), gemfibrozil (Lopid), a medcine that contains zidovudine (Combivir, Retrovir, Trizivir).

ISENTRESS® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in patients 4 weeks of age and older.