Drug information

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Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate
Brand Name
Atripla (brand product discontinued)
Other Names
EFV / FTC / TDF, efavirenz / emtricitabine / tenofovir DF
Drug Class
Combination Drugs
Non-Nucleoside Reverse Transcriptase Inhibitor (efavirenz)
Nucleoside Reverse Transcriptase Inhibitor (emtricitabine, tenofovir DF)
 

What are the most important things to know about efavirenz/emtricitabine/tenofovir DF?What are the most important things to know about efavirenz/emtricitabine/tenofovir DF?

What are the most important things to know about efavirenz/emtricitabine/tenofovir DF?

Efavirenz/emtricitabine/tenofovir DF can cause serious, life-threatening side effects. These include a buildup of lactic acid in the blood (lactic acidosis), liver problems, severe skin rash and allergic reactions, mental health problems, and new or worsening kidney problems, including kidney failure.

Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis:

  • Weakness or tiredness
  • Unusual muscle pain
  • Shortness of breath or fast breathing
  • Stomach pain with nausea and vomiting
  • Cold or blue hands and feet
  • Dizziness or lightheadedness
  • Fast or abnormal heartbeat

Some people taking efavirenz, a component of efavirenz/emtricitabine/tenofovir DF, have had liver problems. People with a history of hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV) or who have elevated results on liver function tests may have an increased risk of developing new or worsening liver problems while taking efavirenz/emtricitabine/tenofovir DF. Liver problems have also occurred in people taking efavirenz who have no history of liver disease.

Contact your health care provider right away if you have any of the following symptoms that could be signs of liver problems:

  • Yellowing of your skin or the whites of your eyes (jaundice)
  • Dark-colored urine
  • Light-colored bowel movements
  • Loss of appetite for several days or longer
  • Nausea or vomiting
  • Pain, aching, or tenderness on the right side of your stomach/abdominal area
  • Itching

If you have both HIV and HBV and take efavirenz/emtricitabine/tenofovir DF, your HBV infection may get much worse (flare up) if you stop taking efavirenz/emtricitabine/tenofovir DF. Do not stop taking efavirenz/emtricitabine/tenofovir DF without first talking with your health care provider.

Contact your health care provider right away if you develop a rash while taking efavirenz/emtricitabine/tenofovir DF. Stop taking efavirenz/emtricitabine/tenofovir DF and get medical help right away if you develop a rash with any of the following symptoms:

  • General ill feeling
  • Extreme tiredness
  • Muscle or joint aches
  • Fever
  • Blistering or peeling skin
  • Blisters or sores in your mouth
  • Redness or swelling of the eyes (conjunctivitis)
  • Swelling of your face, lips, mouth, tongue, or throat
  • Trouble breathing or swallowing

Contact your health care provider right away if you have any of the following symptoms that could be signs of mental health problems:

  • Feeling sad or hopeless
  • Feeling anxious or restless
  • Harming yourself or others or having thoughts about harming yourself (including suicidal thoughts) or others
  • Not being able to tell the difference between what is true or real and what is false or unreal
  • Not trusting other people
  • Hearing or seeing things that are not real
  • Not being able to move or speak normally

Contact your health care provider right away if you have any of the following symptoms that could be signs of a worsening kidney problem (called Fanconi Syndrome), which may be related to tenofovir-containing drugs:

  • Bone pain that does not go away or gets worse
  • Pain in your arms, hand, legs, or feet
  • Broken bones
  • Muscle pain or weakness

While taking efavirenz/emtricitabine/tenofovir DF, it is important to keep all of your appointments with your health care provider.

What is efavirenz/emtricitabine/tenofovir DF?What is efavirenz/emtricitabine/tenofovir DF?

What is efavirenz/emtricitabine/tenofovir DF?

Efavirenz/emtricitabine/tenofovir DF is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children who weigh at least 88 lb (40 kg). Efavirenz/emtricitabine/tenofovir DF can be used alone as a complete treatment regimen or with other HIV medicines.

Efavirenz/emtricitabine/tenofovir DF contains three different HIV medicines: efavirenz, emtricitabine, and tenofovir disoproxil fumarate.

For more information on the use of efavirenz/emtricitabine/tenofovir DF in people with HIV, please refer to the Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV and the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. 

HIV medicines cannot 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 transmission. If you are taking HIV medicines, do not 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 efavirenz/emtricitabine/tenofovir DF?What should I tell my health care provider before taking efavirenz/emtricitabine/tenofovir DF?

What should I tell my health care provider before taking efavirenz/emtricitabine/tenofovir DF?

Before taking efavirenz/emtricitabine/tenofovir DF, tell your health care provider:

  • If you are allergic to any of the HIV medicines in efavirenz/emtricitabine/tenofovir DF (efavirenz, emtricitabine, or tenofovir disoproxil fumarate) or any other medicines.
  • If you have liver problems, including hepatitis B virus infection (HBV) or hepatitis C virus infection (HCV).
  • If you have heart problems.
  • If you have ever had a mental health problem.
  • If you have a history of drug or alcohol abuse.
  • If you have nervous system problems.
  • If you have kidney problems or receive kidney dialysis treatment.
  • If you have bone problems.
  • If you have ever had a seizure or if you take medicine to treat seizures.
  • 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 efavirenz/emtricitabine/tenofovir DF during pregnancy. For more information on the use of efavirenz/emtricitabine/tenofovir DF during pregnancy, please refer to the Recommendations for the Use of Antiretroviral Drugs During Pregnancy and Interventions to Reduce Perinatal HIV Transmission in the United States.
  • If you are breast/chestfeeding or plan to breast/chestfeed. For people with HIV in the United States, the Guideline recommends speaking with your health care provider to discuss options for feeding your baby. People with suppressed viral load have a less than 1% chance of transmitting HIV to their baby via their own milk.
  • If you are using hormone-based birth control (such as pills, implants, or vaginal rings). Efavirenz/emtricitabine/tenofovir DF 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 efavirenz/emtricitabine/tenofovir DF. For more information about using birth control and HIV medicines at the same time, view the HIVinfo HIV and Birth Control infographic.
  • About other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Efavirenz/emtricitabine/tenofovir DF may affect the way other medicines or products work, and other medicines or products may affect how efavirenz/emtricitabine/tenofovir DF works. Taking efavirenz/emtricitabine/tenofovir DF together with certain medicines or products may cause serious side effects.

How should I take efavirenz/emtricitabine/tenofovir DF?How should I take efavirenz/emtricitabine/tenofovir DF?

How should I take efavirenz/emtricitabine/tenofovir DF?

Efavirenz/emtricitabine/tenofovir DF comes in tablet form. Each tablet contains:

Take efavirenz/emtricitabine/tenofovir DF according to your health care provider’s instructions. Do not miss a dose of efavirenz/emtricitabine/tenofovir DF, and do not change your dose or stop taking efavirenz/emtricitabine/tenofovir DF without first talking with your health care provider.

Take efavirenz/emtricitabine/tenofovir DF by mouth and on an empty stomach, preferably at bedtime. Taking efavirenz/emtricitabine/tenofovir DF at bedtime might help to make some of the side effects less bothersome.

If you have taken too much efavirenz/emtricitabine/tenofovir DF, contact your health care provider or local poison control center (1-800-222-1222 or online) right away, or go to the nearest hospital emergency room.

For more information on how to take efavirenz/emtricitabine/tenofovir DF, see the FDA drug label.

What should I do if I forget a dose?What should I do if I forget a dose?

What should I do if I forget a dose?

If you miss a dose of efavirenz/emtricitabine/tenofovir DF, 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 efavirenz/emtricitabine/tenofovir DF cause?What side effects can efavirenz/emtricitabine/tenofovir DF cause?

What side effects can efavirenz/emtricitabine/tenofovir DF cause?

Efavirenz/emtricitabine/tenofovir DF may cause side effects. Some side effects of efavirenz/emtricitabine/tenofovir DF can be serious as noted above. Many side effects from HIV medicines, such as nausea or occasional dizziness, are manageable. See the HIVinfo fact sheet on HIV Medicines and Side Effects for more information.

Other possible side effects of efavirenz/emtricitabine/tenofovir DF include:

  • Nervous system problems, including dizziness, trouble concentrating, abnormal dreams, unusually happy mood, agitation, thought problems, slow thoughts and physical movement, problems sleeping, excessive sleepiness or difficulty awakening, hallucinations, confusion, memory problems, and lack of coordination or balance.
  • Bone problems, including bone pain, or softening or thinning of the bones (osteopenia), which may lead to fractures.
  • Seizures, which are more likely to happen if you have had seizures in the past.
  • Changes in your immune system (called immune reconstitution inflammatory syndrome 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. 
  • Changes in body fat (lipodystrophy syndrome).

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 efavirenz/emtricitabine/tenofovir DF. To learn more about possible side effects of efavirenz/emtricitabine/tenofovir DF, read the drug label or package insert or talk to your health care provider or pharmacist.

You can also report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or online.

How should efavirenz/emtricitabine/tenofovir DF be stored?How should efavirenz/emtricitabine/tenofovir DF be stored?

How should efavirenz/emtricitabine/tenofovir DF be stored?

  • Store efavirenz/emtricitabine/tenofovir DF at room temperature, 68°F to 77°F (20°C to 25°C).
  • Keep efavirenz/emtricitabine/tenofovir DF in the container that it came in and keep the container tightly closed. If the container has a small packet of drying agent (called a desiccant), do not remove it. The desiccant protects the medicine from moisture.
  • Do not use efavirenz/emtricitabine/tenofovir DF if the original seal over the container opening is broken or missing.
  • Throw away efavirenz/emtricitabine/tenofovir DF that is no longer needed or expired (out of date). Follow FDA guidelines on how to safely dispose of medicine.
  • Keep efavirenz/emtricitabine/tenofovir DF and all medicines out of reach of children.

Where can I find more information about efavirenz/emtricitabine/tenofovir DF?Where can I find more information about efavirenz/emtricitabine/tenofovir DF?

Where can I find more information about efavirenz/emtricitabine/tenofovir DF?

Manufacturer Information

Atripla brand product is discontinued. For manufacturer information on a generic efavirenz/emtricitabine/tenofovir DF product, please refer to the generic drug label or the manufacturer’s website.

 

Last Reviewed: July 2, 2024