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Brand Names: Atripla

Generic Name: efavirenz, emtricitabine, and tenofovir (Pronunciation: ef AV ir enz, em trye SYE ta been, and ten OF oh vir)

• What is efavirenz, emtricitabine, and tenofovir (Atripla)?
• What are the possible side effects of efavirenz, emtricitabine, and tenofovir (Atripla)?
• What is the most important information I should know about efavirenz, emtricitabine, and tenofovir (Atripla)?
• What should I discuss with my healthcare provider before taking efavirenz, emtricitabine, and tenofovir (Atripla)?
• How should I take efavirenz, emtricitabine, and tenofovir (Atripla)?
• What happens if I miss a dose (Atripla)?
• What happens if I overdose (Atripla)?
• What should I avoid while taking efavirenz, emtricitabine, and tenofovir (Atripla)?
• What other drugs will affect efavirenz, emtricitabine, and tenofovir (Atripla)?
• Where can I get more information?

What is efavirenz, emtricitabine, and tenofovir (Atripla)?

Efavirenz, emtricitabine, and tenofovir is an antiviral medication that prevents human immunodeficiency virus (HIV) from reproducing in your body.

Efavirenz, emtricitabine, and tenofovir treats HIV, which causes acquired immunodeficiency syndrome (AIDS). Efavirenz, emtricitabine, and tenofovir is not a cure for HIV or AIDS.

Efavirenz, emtricitabine, and tenofovir may also be used for other purposes not listed in this medication guide.

What are the possible side effects of efavirenz, emtricitabine, and tenofovir (Atripla)?

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.

Efavirenz, emtricitabine, and tenofovir 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, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

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

• signs of liver damage - nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• urinating less than usual or not at all;
• fever, chills, body aches, flu symptoms;
• unusual thoughts or behavior, severe depression, extreme fear, thoughts of hurting yourself or others, hallucinations;
• severe blistering, peeling, and red skin rash; or
• seizure (convulsions).

Less serious side effects may include:

• dizziness, drowsiness, anxiety, depressed mood;
• headache, tired feeling, ringing in your ears, vision problems;
• sleep problems (insomnia), confusion, strange dreams, forgetfulness;
• mild nausea, vomiting, diarrhea, loss of appetite, upset stomach;
• darkened skin on the palms of your hands or the soles of your feet;
• joint pain, back pain;
• numbness or tingly feeling;
• runny or stuffy nose, cough; 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.

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

Do not use this medication while you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication, and for at least 12 weeks after your treatment ends. Tell your doctor if you become pregnant during treatment.

Do not take this medication if you are also taking cisapride (Propulsid), midazolam (Versed), triazolam (Halcion), St. John's wort, voriconazole (Vfend), or an ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine). Do not take this medication with other medicines that also contain efavirenz, emtricitabine, tenofovir (Sustiva, Emtriva, Truvada, or Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).

There are many other medicines that can cause interactions or serious medical problems if you take them together with efavirenz, emtricitabine, and tenofovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Some people have developed a life-threatening condition called lactic acidosis while taking this medication. 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, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Efavirenz, emtricitabine, 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).