"On January 7, 2010, FDA approved an updated Atripla label including new efficacy, safety and resistance data in treatment experienced patients from a trial (Study 073: A Phase IV, Open-Label, Randomized, Multicenter Study Evaluating Efficacy "...
Atripla Consumer (continued)
Dizziness, trouble sleeping, drowsiness, unusual dreams, and trouble concentrating may frequently occur. These side effects may begin 1-2 days after starting this medication and usually go away in 2-4 weeks. They are also reduced by taking this medication on an empty stomach at bedtime.
Tiredness, headache, nausea, vomiting, diarrhea, and skin discoloration (such as small spots/freckles, darkening of the palms of the hands/soles of the feet) may also occur.
If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Some people may experience worsening of a previous medical condition (such as an old infection) as their immune systems improve, or develop new conditions because their immune systems have become overactive. This reaction may occur at any time (soon after starting HIV treatment or many months later). Tell your doctor right away if you have any serious side effects, including: unexplained weight loss, persistent muscle aches/weakness, joint pain, numbness/tingling of the hands/feet/arms/legs, severe tiredness, vision changes, severe/persistent headaches, signs of infection (such as fever, chills, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre Syndrome (such as difficulty breathing/swallowing/moving your eyes, drooping face, paralysis, slurred speech).
Infrequently, serious psychiatric symptoms may occur during efavirenz/emtricitabine/tenofovir treatment. These effects may be seen especially in people who have mental/mood conditions. Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as depression, rare thoughts of suicide, strange thoughts, anxiety, angry behavior, hallucinations, confusion).
Tell your doctor immediately if any of these rare but serious side effects occur: signs of kidney problems (such as a change in the amount of urine), unusual thirst, signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).
Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.
Tenofovir may increase the risk of bone loss. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of calcium and vitamin D to reduce this side effect. If you are at risk for bone loss, your doctor may monitor your bone mineral density. Tell your doctor right away if any of the following serious side effects occur: bone pain, easily broken bones.
Efavirenz/emtricitabine/tenofovir can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, seek immediate medical attention if you develop any rash.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, blisters, peeling skin, fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Atripla (efavirenz, emtricitabine, and tenofovir disoproxil fumarate) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking efavirenz/emtricitabine/tenofovir, tell your doctor or pharmacist if you are allergic to any of the ingredients; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems (such as hepatitis B or C, cirrhosis), mental/mood conditions (such as depression, thoughts of suicide, psychosis), drug/substance/alcohol abuse, seizures, high cholesterol/triglyceride levels, bone problems (such as bone disease, bone loss/osteoporosis, weak/broken bones), disease of the pancreas (pancreatitis).
This drug may make you dizzy or drowsy or cause trouble concentrating. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
Avoid alcohol and street drugs because they may worsen the side effects of this medication (such as liver problems, pancreatitis, dizziness, drowsiness, mental/mood symptoms).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
A rash may be more common and serious in children taking this medication. Report any rash immediately. The doctor may prescribe an antihistamine for your child to take before this medication is started. Consult the doctor for more information.
This medication is not recommended for use during pregnancy. It may harm an unborn baby, especially if taken during the first 3 months of pregnancy. Women of childbearing age should have a pregnancy test before starting efavirenz/emtricitabine/tenofovir. It is important to prevent pregnancy while taking this medication and for 3 months after treatment. Consult your doctor about using at least 2 reliable forms of birth control (such as condoms with birth control pills) during treatment and for 3 months after the end of treatment (see also Drug Interactions section). If you become pregnant or think you may be pregnant, tell your doctor immediately. Discuss the risks and benefits and other HIV treatment options during pregnancy to decrease the risk of HIV transmission to the baby.
This medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Additional Atripla Information
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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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