Emtricitabine, rilpivirine, and tenofovir is a combination antiviral medicine that is used to treat human immunodeficiency virus (HIV), the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS.

Emtricitabine, rilpivirine, and tenofovir is for use in adults and children who are at least 12 years old and who weigh at least 77 pounds (35 kilograms).

Emtricitabine, rilpivirine, and tenofovir may also be used for purposes not listed in this medication guide.

You should not take Complera or Odefsey if you are allergic to emtricitabine, rilpivirine, or tenofovir.

This medicine is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).

There are many other drugs that can make Complera or Odefsey less effective and should not be used at the same time:

• dexamethasone (more than 1 dose);
• St. John's wort;
• tuberculosis medication--rifampin, rifapentine;
• seizure medicine--carbamazepine, oxcarbazepine, phenobarbital, phenytoin; or
• stomach acid reducers--dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease (including hepatitis B or C);
• depression or suicidal thoughts; or
• bone problems.

Your doctor will perform blood tests to make sure you do not have hepatitis B.

Tell your doctor if you are pregnant, and use your medications properly to control your infection. HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of antiviral medicine on the baby.

Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.

Use Odefsey (Emtricitabine, Rilpivirine, And Tenofovir) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: a blistering skin rash, fever, mouth sores, eye redness, swollen glands, trouble breathing or swallowing, right-sided upper stomach pain, unusual bruising, or dark urine.

Call your doctor at once if you have:

• depression or mood changes, anxiety, restlessness, suicidal thoughts or actions;
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
• lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; or
• liver problems--stomach pain, nausea, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This medicine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
• trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

• headache, dizziness, tiredness;
• depressed mood, trouble sleeping, strange dreams;
• rash; or
• nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using this medicine will not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.