Rilpivirine can cause serious, life-threatening side effects. These include depression, mood changes, and liver problems.
Contact your health care provider right away if you have any of the following symptoms of depression or mood changes:
Some people taking rilpivirine have had liver problems. People with a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking rilpivirine. Liver problems have also occurred in people taking rilpivirine who have no history of liver disease. Liver function tests may be done before and during treatment with rilpivirine.
While taking rilpivirine, it is important to keep all of your appointments with your health care provider.
Rilpivirine is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children 12 years of age and older who have never taken HIV medicines before and who have a viral load (number of HIV RNA copies per mL of blood) of 100,000 copies/mL or less at the start of treatment. Rilpivirine is always used in combination with other HIV medicines.
Rilpivirine belongs to a class (group) of HIV drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs). NNRTIs attach to and block an HIV enzyme called reverse transcriptase. (An enzyme is a protein that starts or increases the speed of a chemical reaction.) By blocking reverse transcriptase, NNRTIs 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 treatment regimen) every day helps people with HIV live longer, healthier lives. HIV medicines also reduce the risk of HIV transmission. If you are taking HIV medicines, including rilpivirine, don’t cut down on, skip, or stop taking them unless your health care provider tells you to.
Before taking rilpivirine, tell your health care provider:
Rilpivirine comes in tablet form, under the brand name Edurant. Each tablet contains 25 mg rilpivirine.
Take rilpivirine according to your health care provider’s instructions.
Always take rilpivirine with a meal. (A protein drink alone does not replace a meal.)
Always take rilpivirine in combination with other HIV medicines.
If you take too much rilpivirine, 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 rilpivirine, 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 rilpivirine within 12 hours of the time you usually take it, take your dose with a meal as soon as possible. Then take your next dose at the regularly scheduled time. If you miss a dose by more than 12 hours from the time you usually take it, wait and then take the next dose at the regularly scheduled time.
Rilpivirine can cause serious, life-threatening side effects. These include depression, mood changes, and liver problems. (See the WARNING above.)
Other possible side effects of rilpivirine 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 rilpivirine. To learn more about possible side effects of rilpivirine, 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 rilpivirine.
You can also 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 rilpivirine is available:
Janssen Pharmaceuticals, Inc.
Last Reviewed: September 15, 2015