Severe, life-threatening, and fatal skin reactions and allergic reactions have been reported in some patients taking ISENTRESS. 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.

Liver problems may be caused by an allergic reaction. Contact your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or whites of the eyes, dark or tea colored urine, pale colored stools/bowel movements, nausea/vomiting, loss of appetite, pain, aching or tenderness on the right side below the ribs.

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 doctor right away if you start having new symptoms after starting your HIV medicines.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS. This is because on rare occasions muscle problems can be serious and can lead to kidney damage.

When ISENTRESS has been given with other anti-HIV drugs, side effects included nausea, headache, tiredness, weakness, trouble sleeping, stomach pain, dizziness, depression, and suicidal thoughts and actions.

Other side effects include feeling anxious, paranoia, low blood platelet count, and diarrhea.

People taking ISENTRESS may still develop infections, including opportunistic infections or other conditions that occur with HIV infection.

Tell your doctor about all of your medical conditions, including if you have any allergies, are pregnant or plan to become pregnant, or are breast-feeding or plan to breast-feed. ISENTRESS is not recommended for use during pregnancy. Women with HIV should not breast-feed 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 used to treat infections such as tuberculosis), non-prescription medicines, vitamins, and herbal supplements.

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 read the Patient Information for ISENTRESS and discuss it with your doctor. The physician Prescribing Information also is available.