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 could be signs of liver problems:
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:
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.
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 drugs 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.
HIV medicines can’t cure HIV/AIDS, but taking a combination of HIV medicines (called an HIV regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission.
Before taking darunavir, tell your health care provider:
Darunavir (brand name: Prezista) comes in the following forms and strengths:
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 your health care provider.
Take darunavir and ritonavir at the same time with food.
Take (or give) darunavir oral suspension with 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 information about the right way to prepare and take a dose.
If your or your child's prescribed dose of darunavir oral suspension is more than 6 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 from DailyMed. (DailyMed is a federal website that includes the most recent drug labels submitted to FDA.)
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.
Darunavir may cause side effects. Most side effects from darunavir are manageable, but a few can be serious. Serious side effects of darunavir include liver problems and severe skin reactions or rash. (See the WARNING box above.)
Other possible side effects of darunavir include:
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 or package insert or talk to your health care provider or pharmacist.
The AIDSinfo fact sheet on HIV Medicines and Side Effects also includes information that may apply to darunavir.
You can report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online at https://www.accessdata.fda.gov/scripts/medwatch/.
More information about darunavir is available:
Janssen Pharmaceuticals, Inc.
Last Reviewed: September 20, 2016