What are the most important things to know about darunavir?
Darunavir can cause serious, life-threatening side effects. These includeproblems and severe skin reactions or rash.
Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:
- Dark-colored urine
- Yellowing of your skin or the whites of your eyes ( )
- Pale-colored bowel movements
- Pain or tenderness on your right side below your ribs
- Loss of appetite
Some people taking darunavir in combination with ritonavir (an HIV medicine always used with darunavir) have had liver problems, which may life-threatening. People with a history of chronic (HBV) or (HCV) may have an increased risk of developing new or worsening liver problems while taking darunavir in combination with ritonavir. Liver function tests may be done before and during treatment with darunavir.
Contact your health care provider right away if you develop a rash. Stop taking darunavir (and ritonavir) and contact your health care provider immediately if you develop any skin reactions along with the following symptoms:
- Muscle or joint pain
- Blisters or skin lesions
- Mouth sores or ulcers
- Redness or swelling of your eyes (conjunctivitis)
Taking darunavir with certain other medicines may cause serious, life-threatening side effects.
While taking darunavir, it is important to keep all of your appointments with your health care provider.
What is darunavir?
HIV medicines can’t cure HIV/AIDS, but taking HIV medicines every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV. If you are taking HIV medicines, don't cut down on, skip, or stop taking them unless your health care provider tells you to.
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 B infection (HBV) or hepatitis C virus infection (HCV).
- If you have high blood sugar ( ) or .
- If you have .
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. Talk to your health care provider about the risks and benefits of taking darunavir during pregnancy.
- If you are breastfeeding or plan to breastfeed. Do not breastfeed if you have HIV or are taking darunavir.
- If you are using HIV and Birth Control infographic. -based birth control (such as pills, implants, or vaginal rings). 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. For more information about using birth control and HIV medicines at the same time, view the
- About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products (particularly St. John’s wort) 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, life-threatening side effects.
How should I take darunavir?
Darunavir(brand name: Prezista)comes in the following forms and strengths:
- 75-mg tablets
- 150-mg tablets
- 600-mg tablets
- 800-mg tablets
- 100-mg/mL oral suspension
Take darunavir according to your health care provider’s instructions.
If your child is prescribed darunavir, follow the instructions for using the drug given to you by their health care provider.
Take darunavir and ritonavir at the same time with food.
Take (or give) darunavir oral suspension using the oral dosing syringe that comes with the medicine. Shake the oral suspension well before each use. See the instructions that come with darunavir oral suspension for more information about the right way to prepare and take a .
If your or your child's prescribed dose of darunavir oral suspension is more than six mL, you will need to divide the dose. Follow the instructions given to you by your health care provider or pharmacist about how to divide the dose. Ask your health care provider or pharmacist if you are not sure how to do this.
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.
What should I do if I forget a dose?
If you miss a dose of darunavir, 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 darunavir cause?
Darunavir may cause side effects. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the ClinicalInfo fact sheet on HIV Medicines and Side Effects for more information.
Some side effects of darunavir can be serious.Serious side effects of darunavir include liver problems and severe skin reactions or rash. (See section above: What are the most important things to know about darunavir?)
Other possible side effects of darunavir include:
- Diabetes and high blood sugar (hyperglycemia).
- Changes in body fat ( ).
- Changes in your (called or IRIS). IRIS is a condition that sometimes occurs when the immune system begins to recover after treatment with an HIV medicine. As the immune system gets stronger, it may have an increased response to a previously hidden infection.
- Increased bleeding in people with hemophilia.
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. To learn more about possible side effects of darunavir, read the drug label oror talk to your health care provider or pharmacist.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.
How should darunavir be stored?
- Store darunavir tablets and oral suspension at room temperature, 68°F to 77°F (20°C to 25°C). Keep darunavir oral suspension 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.
- Do not use darunavir if the original seal over the container opening is broken or missing.
- Throw away darunavir that is no longer needed or expired (out of date).Follow FDA guidelines on how to safely dispose of unused medicine.
- Keep darunavir and all medicines out of reach of children.
Where can I find more information about darunavir?
More information about darunavir is available:
Main number: 800-526-7736
Patient assistance: 800-652-6227
Janssen CarePath: 866-836-0114
The above Patient Version drug summary is based on the following FDA label(s): Oral suspension, tablet (film coated).
Last Reviewed: August 27, 2019