April 28, 2017
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Complera Patient Information Including Side Effects

Brand Names: Complera

Generic Name: emtricitabine, rilpivirine, and tenofovir (Pronunciation: em trye SYE ta been, RIL pi VIR een, and ten OF oh vir)

What is emtricitabine, rilpivirine, and tenofovir (Complera)?

Emtricitabine, rilpivirine, and tenofovir are antiviral drugs that prevent preventing HIV (human immunodeficiency virus) cells from multiplying in the body.

The combination of emtricitabine, rilpivirine, and tenofovir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Emtricitabine, rilpivirine, and tenofovir is not a cure for HIV or AIDS.

This combination medicine should not be taken together with other antiviral medications to treat HIV or AIDS.

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

What are the possible side effects of emtricitabine, rilpivirine, and tenofovir (Complera)?

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

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as:

  • muscle pain or weakness;
  • numb or cold feeling in your arms and legs;
  • trouble breathing;
  • feeling dizzy, light-headed, tired, or very weak;
  • stomach pain, nausea with vomiting; or
  • fast or uneven heart rate.

Call your doctor at once if you have any of these other serious side effects:

  • signs of liver damage - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • confusion, severe depression, unusual thoughts or behavior, suicidal thoughts or actions;
  • increased thirst and urination, weakness, constipation;
  • urinating less than usual or not at all;
  • swelling, rapid weight gain, feeling short of breath;
  • signs of infection such as fever, chills, skin lesions, or cough with yellow or green mucus.

Less serious side effects may include:

  • headache, mild tired feeling;
  • dizziness, depressed mood;
  • sleep problems (insomnia), strange dreams;
  • diarrhea, mild nausea; or
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

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.

Read the Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate tablets) Side Effects Center for a complete guide to possible side effects

What is the most important information I should know about emtricitabine, rilpivirine, and tenofovir (Complera)?

You should not take this medication if you are allergic to emtricitabine (Emtriva), rilpivirine (Edurant), or tenofovir (Viread).

Do not take this medication with other medicines that also contain emtricitabine, rilpivirine, or tenofovir (Atripla, Edurant, Emtriva, Truvada, Viread), or adefovir or lamivudine (Combivir, Epivir, Epzicom, Hepsera, or Trizivir).

Some people develop lactic acidosis while taking tenofovir. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Emtricitabine, rilpivirine, and tenofovir can cause severe or fatal liver problems. Call your doctor at once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Side Effects Centers

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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