Isentress Side Effects

Isentress (raltegravir) is an antiviral medication that prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Isentress is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

You should not use Isentress if you are allergic to raltegravir.

To make sure you can safely take Isentress, tell your doctor if you have any of these other conditions:

  • a muscle disorder;
  • kidney disease;
  • liver disease;
  • a history of mental illness or depression.

FDA pregnancy category C. It is not known whether Isentress will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Isentress. HIV can be passed to your baby if you are not properly treated during pregnancy. Take all of your HIV medicines as directed to control your infection.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Isentress on the baby.

Women with HIV or AIDS should not breast-feed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

The Isentress chewable tablet may contain phenylalanine. Talk to your doctor before using this form of Isentress if you have phenylketonuria (PKU).

Get emergency medical help if you have any of these signs of an allergic reaction to Isentress: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Isentress can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising or bleeding;
  • signs of a new infection, such as fever or chills, cough, or flu symptoms;
  • drowsiness, confusion, increased thirst, lower back pain, urinating less than usual or not at all;
  • depressed mood, unusual thoughts about hurting yourself;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
  • severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious Isentress side effects may include:

  • headache, sleep problems (insomnia);
  • mild stomach pain, vomiting, diarrhea;
  • tired feeling;
  • dizziness; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.