Raltegravir can cause serious, life-threatening side effects. These include skin reactions, allergic reactions, and liver problems.
Raltegravir chewable tablets contain phenylalanine as part of the artificial sweetener aspartame. The artificial sweetener may be harmful to people with phenylketonuria (PKU).
Stop taking raltegravir and contact your health care provider right away if you develop a rash with any of the following symptoms:
- General ill feeling.
- Extreme tiredness.
- Muscle or joint aches.
- Blisters or sores in your mouth.
- Blisters or peeling of your skin.
- Redness or swelling of your eyes.
- Swelling of your mouth or face.
- Trouble breathing.
An allergic reaction to raltegravir can cause liver problems. Contact your health care provider right away if you have any of the following symptoms that may signal liver problems:
- Yellowing of your skin or the whites of your eyes (jaundice).
- Dark-colored urine.
- Light-colored bowel movements.
- Loss of appetite.
- Pain, aching, or tenderness on the right side below your ribs.
While taking raltegravir, it is important to keep all of your appointments with your health care provider.
What is raltegravir?
Raltegravir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 4 weeks of age and older. Raltegravir is always used in combination with other HIV medicines.
Raltegravir belongs to a class (group) of HIV drugs called integrase inhibitors. Integrase inhibitors block an HIV enzyme called integrase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking integrase, integrase inhibitors prevent HIV from multiplying and can reduce the amount of HIV in the body.
Raltegravir does not cure HIV/AIDS. People with HIV should stay on continuous HIV treatment as directed by their health care provider and should take steps to avoid passing HIV to others (for example, always using a condom during sex).
What should I tell my health care provider before taking raltegravir?
Before taking raltegravir, tell your health care provider:
- If you are allergic to raltegravir or any other medicines.
- If you have liver problems.
- If you have a history of a muscle disorder called rhabdomyolysis or myopathy.
- If you have increased levels of creatine kinase (an enzyme found mainly in the heart, brain, and skeletal muscle) in your blood.
- If you have phenylketonuria (PKU). Raltegravir chewable tablets contain phenylalanine as part of the artificial sweetener aspartame. Phenylalanine may be harmful to people with PKU.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether raltegravir can harm an unborn baby is unknown.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you are infected with HIV or are taking raltegravir.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Raltegravir may affect the way other medicines or products work, and other medicines or products may affect how raltegravir works. Taking raltegravir together with certain medicines or products may cause serious side effects.
How should I take raltegravir?
Raltegravir comes in the following forms and strengths:
- 400-mg film-coated tablets (brand name: Isentress).
- 25-mg and 100-mg chewable tablets (brand name: Isentress).
- 100-mg single-use packets for oral suspension (brand name: Isentress). (Note: This formulation is not yet available. The drug manufacturer expects to have raltegravir for oral suspension commercially available by the third quarter of 2014.)
Take raltegravir according to your health care provider’s instructions.
Take raltegravir by mouth, with or without food. Always swallow the film-coated tablets whole. The chewable tablets may be chewed or swallowed. Raltegravir for oral suspension must be mixed with water before use and given within 30 minutes of mixing. Raltegravir for oral suspension comes in a kit that contains the packets of raltegravir and reusable syringes and cups needed to mix and give the medicine. See the detailed instructions that come with the kit for information about the correct way to mix and give a dose of raltegravir for oral suspension. If you have questions about how to mix or give raltegravir for oral suspension, talk to your health care provider or pharmacist.
Do not switch between the film-coated tablet, the chewable tablet, or the oral suspension without talking with your health care provider first.
Always take raltegravir in combination with other HIV medicines.
If you take too much raltegravir, contact your health care provider or local poison control center (1-800-222-1222) right away, or go to the nearest hospital emergency room.
For more information on how to take raltegravir, see the FDA drug label from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. But if it is almost time for your next dose, skip the missed dose and just take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.
What side effects can raltegravir cause?
Raltegravir can cause serious, life-threatening side effects. These include skin reactions, allergic reactions, and liver problems. (See the WARNING above.)
Other possible side effects of raltegravir include:
- Changes in the immune system (immune reconstitution inflammatory syndrome [IRIS]).
- Unexplained muscle pain, tenderness, or weakness. This may be a sign of a rare but serious muscle problem that can lead to kidney problems.
Tell your health care provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of raltegravir. Ask your health care provider or pharmacist for more information on possible side effects of raltegravir.
You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
How should raltegravir be stored?
- Store raltegravir at room temperature, 68°F to 77°F (20°C to 25°C).
- Keep raltegravir film-coated tablets in the container that they came in and keep the container tightly closed.
- Keep raltegravir chewable tablets in the container that they came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture. Do not use raltegravir chewable tablets if the original seal over the bottle opening is broken or missing.
- Keep raltegravir for oral suspension in the container that it came in. Do not open the foil packet until ready for use.
- Safely throw away raltegravir that is no longer needed or expired (out of date).
- Keep raltegravir and all medicines out of reach of children.
Where can I find more information about raltegravir?
More information about raltegravir is available:
Last Reviewed: February 4, 2014
Last Updated: February 4, 2014