Darunavir can cause serious, life-threatening side effects. These include liver problems and severe skin reactions or rash.
Contact your health care provider right away if you have any of the following symptoms that may signal liver problems:
- Dark-colored urine.
- Yellowing of your skin or the whites of your eyes (jaundice).
- Light-colored bowel movements.
- Pain or tenderness on the right side below your ribs.
- Loss of appetite.
Contact your health care provider right away if you develop a rash. Stop taking darunavir (and ritonavir, the HIV medicine always used with darunavir) and contact your health care provider immediately if you develop any skin changes along with the following symptoms:
- Muscle or joint pain.
- Blisters or skin lesions.
- Mouth sores or ulcers.
- Red or inflamed eyes, like “pink eye” (conjunctivitis).
Taking darunavir with certain other medicines may cause serious side effects.
While taking darunavir, it is important to keep all of your appointments with your health care provider.
What is darunavir?
Darunavir is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 3 years of age and older. Darunavir is always used in combination with the HIV medicine ritonavir (brand name: Norvir) and other HIV medicines.
Darunavir belongs to a class (group) of HIV medicines called protease inhibitors (PIs). PIs block an HIV enzyme called protease. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking protease, PIs prevent HIV from multiplying and can reduce the amount of HIV in the body.
Darunavir does not cure HIV/AIDS. It is not known if darunavir reduces the risk of passing HIV to other people. 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 darunavir?
Before taking darunavir, tell your health care provider:
- If you are allergic to darunavir, sulfa medicines, or any other medicines.
- If you have liver problems, including hepatitis B virus (HBV) infection or hepatitis C virus (HCV) infection.
- If you have high blood sugar (hyperglycemia) or diabetes.
- If you have hemophilia.
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Whether darunavir 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 darunavir.
- If you are using estrogen-based birth control (such as pills, injections, or implants). Darunavir may make these forms of birth control less effective. Your health care provider can help you decide how to adjust your birth control while you are taking darunavir.
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Darunavir may affect the way other medicines or products work, and other medicines or products may affect how darunavir works. Taking darunavir together with certain medicines or products may cause serious side effects.
How should I take darunavir?
Darunavir comes in the following forms and strengths:
- 75-mg tablets (brand name: Prezista).
- 150-mg tablets (brand name: Prezista).
- 400-mg tablets (brand name: Prezista).
- 600-mg tablets (brand name: Prezista).
- 800-mg tablets (brand name: Prezista).
- 100-mg/mL oral suspension (brand name: Prezista).
Take darunavir according to your health care provider’s instructions. If your child is prescribed darunavir, follow the instructions given to you by your health care provider for using the drug.
Always take darunavir in combination with the HIV medicine ritonavir (brand name: Norvir) and other HIV medicines.
Take darunavir and ritonavir at the same time with food. Swallow darunavir tablets whole with a drink.
Take (or give) darunavir oral suspension with the oral dosing syringe that comes with the medicine. See the instructions that come with darunavir oral suspension for information about the right way to prepare and take a dose. Shake the oral suspension well before each use.
If you take too much darunavir, 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 darunavir, 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?
For people who take darunavir one time a day: If you miss a dose by less than 12 hours, take your missed dose of darunavir right away. Then take your next dose at your regularly scheduled time. If you miss a dose by more than 12 hours, wait and then take the next dose at your regularly scheduled time.
For people who take darunavir two times a day: If you miss a dose by less than 6 hours, take your missed dose of darunavir right away. Then take your next dose at your regularly scheduled time. If you miss a dose by more than 6 hours, wait and then take the next dose at your regularly scheduled time.
Do not take two doses at the same time to make up for a missed dose.
What side effects can darunavir cause?
Darunavir can cause serious, life-threatening side effects. These include liver problems and severe skin reactions or rash. (See the WARNING above.)
Other possible side effects of darunavir include:
- Diabetes and high blood sugar (hyperglycemia).
- Changes in body fat (lipodystrophy).
- Changes in the immune system (immune reconstitution inflammatory syndrome [IRIS]).
- Increased bleeding in people with hemophilia.
- Nausea and/or vomiting.
- Abdominal pain.
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 darunavir. Ask your health care provider or pharmacist for more information on possible side effects of darunavir. You may also want to read this fact sheet about HIV medicines and side effects.
You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088).
How should darunavir be stored?
- Store darunavir tablets and oral suspension at room temperature, 77°F (25°C). Keep darunavir away from high heat. Do not refrigerate or freeze darunavir oral suspension.
- Keep darunavir in the container that it came in and keep the container tightly closed. If the darunavir tablets 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 darunavir if the original seal over the bottle opening is broken or missing.
- Safely throw away darunavir that is no longer needed or expired (out of date).
- Keep darunavir and all medicines out of reach of children.
Where can I find more information about darunavir?
More information about darunavir is available:
Janssen Pharmaceuticals, Inc.
Last Reviewed: April 11, 2014
Last Updated: April 11, 2014