"The U.S. Food and Drug Administration today approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. "...
Atripla Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) treats HIV, which causes acquired immunodeficiency syndrome (AIDS). This medication is not a cure for HIV or AIDS. It is an antiviral medication. Common side effects include dizziness, trouble sleeping, drowsiness, unusual dreams, and trouble concentrating. Effects may begin 1-2 days after starting this medication and usually go away in 2-4 weeks. 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.
The adult dose of Atripla is one tablet once daily taken orally on an empty stomach. Dosing at bedtime may improve the tolerability of nervous system symptoms. Atripla may interact with acyclovir, ganciclovir, valacyclovir, valganciclovir, sertraline, methadone, adefovir, cidofovir, blood thinners, cholesterol medications, antibiotics, calcium channel blockers, seizure medicines, or other HIV medicines. Tell your doctor all medications you use. Atripla is not recommended for use during pregnancy. It may harm a fetus, especially if taken during the first 3 months of pregnancy. Women of childbearing age should have a pregnancy test before starting Atripla. Consult your doctor about using 2 forms of birth control (such as condoms with birth control pills) during treatment and for 3 months after the end of treatment. Atripla decreases effectiveness of hormonal birth control, so barrier protection must be used. If you become pregnant or think you may be pregnant, tell your doctor. Discuss other HIV treatment options during pregnancy to decrease risk of HIV transmission to the baby. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
Our Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Atripla in Detail - Patient Information: Side Effects
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, stomach pain, nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
Stop using this medication and call your doctor at once if you have any other serious side effects such as:
- signs of liver damage - nausea, upper stomach pain, itching, 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, anger, severe depression, thoughts of hurting yourself or others, hallucinations;
- severe blistering, peeling, and red skin rash; or
- seizure (convulsions).
Less serious side effects may include:
- mild nausea, vomiting, diarrhea, gas, upset stomach;
- headache, dizziness, drowsiness, tired feeling;
- trouble concentrating;
- sleep problems (insomnia), strange dreams;
- darkened skin on the palms of your hands or the soles of your feet; 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 entire detailed patient monograph for Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Atripla Overview - Patient Information: Side Effects
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, bone pain, easily broken bones, 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.
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 entire patient information overview for Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Atripla FDA Prescribing Information: Side Effects
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate: The following adverse reactions are discussed in other sections of the labeling:
- Lactic Acidosis/Severe Hepatomegaly with Steatosis [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Severe Acute Exacerbations of Hepatitis B [See BOXED WARNING, WARNINGS AND PRECAUTIONS].
- Psychiatric Symptoms [See WARNINGS AND PRECAUTIONS].
- Nervous System Symptoms [See WARNINGS AND PRECAUTIONS].
- New Onset or Worsening Renal Impairment [See WARNINGS AND PRECAUTIONS].
- Rash [See WARNINGS AND PRECAUTIONS].
- Hepatotoxicity [See WARNINGS AND PRECAUTIONS].
- Decreases in Bone Mineral Density [See WARNINGS AND PRECAUTIONS].
- Immune Reconstitution Syndrome [See WARNINGS AND PRECAUTIONS].
- Drug Interactions [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
For additional safety information about SUSTIVA (efavirenz), EMTRIVA (emtricitabine), or VIREAD (tenofovir DF) in combination with other antiretroviral agents, consult the prescribing information for these products.
Adverse Reactions from Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials in Adult Subjects
Study 934 was an open-label active-controlled trial in which 511 antiretroviral-naive subjects received either emtricitabine + tenofovir DF administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254).
The most common adverse reactions (incidence greater than or equal to 10%, any severity) occurring in Study 934 include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Adverse reactions observed in Study 934 were generally consistent with those seen in previous trials of the individual components (Table 2).
Table 2 : Selected Treatment-Emergent Adverse
Reactionsa (Grades 2-4) Reported in ≥ 5% in Either
Treatment Group in Study 934 (0-144 Weeks)
|FTC + TDF + EFVb
|AZT/3TC + EFV
|General Disorders and Administration Site Condition|
|Infections and Infestations|
|Upper respiratory tract infections||8%||5%|
|Nervous System Disorders|
|Skin and Subcutaneous Tissue Disorders|
|aFrequencies of adverse reactions are based on
all treatment-emergent adverse events, regardless of relationship to study
bFrom Weeks 96 to 144 of the trial, subjects received emtricitabine/tenofovir DF administered in combination with efavirenz in place of emtricitabine + tenofovir DF with efavirenz.
cRash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.
In Study 073, subjects with stable, virologic suppression on antiretroviral therapy and no history of virologic failure were randomized to receive ATRIPLA or to stay on their baseline regimen. The adverse reactions observed in Study 073 were generally consistent with those seen in Study 934 and those seen with the individual components of ATRIPLA when each was administered in combination with other antiretroviral agents.
Efavirenz, Emtricitabine, or Tenofovir Disoproxil Fumarate
In addition to the adverse reactions in Study 934 and Study 073 the following adverse reactions were observed in clinical trials of efavirenz, emtricitabine, or tenofovir DF in combination with other antiretroviral agents.
Efavirenz: The most significant adverse reactions observed in subjects treated with efavirenz are nervous system symptoms [See WARNINGS AND PRECAUTIONS], psychiatric symptoms [See WARNINGS AND PRECAUTIONS], and rash [See WARNINGS AND PRECAUTIONS].
Selected adverse reactions of moderate-severe intensity observed in greater than or equal to 2% of efavirenz-treated subjects in two controlled clinical trials included pain, impaired concentration, abnormal dreams, somnolence, anorexia, dyspepsia, abdominal pain, nervousness, and pruritus.
Pancreatitis has also been reported, although a causal relationship with efavirenz has not been established. Asymptomatic increases in serum amylase levels were observed in a significantly higher number of subjects treated with efavirenz 600 mg than in control subjects.
Emtricitabine and Tenofovir Disoproxil Fumarate: Adverse reactions that occurred in at least 5% of treatment-experienced or treatment-naive subjects receiving emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials include arthralgia, increased cough, dyspepsia, fever, myalgia, pain, abdominal pain, back pain, paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy), pneumonia, rhinitis and rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash and allergic reaction).
Skin discoloration has been reported with higher frequency among emtricitabine-treated subjects; it was manifested by hyperpigmentation on the palms and/or soles and was generally mild and asymptomatic. The mechanism and clinical significance are unknown.
Clinical Trials in Pediatric Subjects
Efavirenz: In a pediatric clinical trial in 57 NRTI-experienced subjects aged 3 to 16 years, the type and frequency of adverse experiences was generally similar to that of adult subjects with the exception of a higher incidence of rash, which was reported in 46% (26/57) of pediatric subjects compared to 26% of adults, and a higher frequency of Grade 3 or 4 rash reported in 5% (3/57) of pediatric subjects compared to 0.9% of adults [See WARNINGS AND PRECAUTIONS]. For additional information, please consult the SUSTIVA prescribing information.
Emtricitabine: In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with emtricitabine in the larger of two open-label, uncontrolled pediatric trials (N=116). For additional information, please consult the EMTRIVA prescribing information.
Tenofovir Disoproxil Fumarate: In a pediatric clinical trial conducted in subjects 12 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with tenofovir DF were consistent with those observed in clinical trials of tenofovir DF in adults [See WARNINGS AND PRECAUTIONS].
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate: Laboratory abnormalities observed in Study 934 were generally consistent with those seen in previous trials (Table 3).
Table 3 : Significant Laboratory Abnormalities
Reported in ≥ 1% of Subjects in Either Treatment Group in Study 934
|FTC + TDF + EFVa
|AZT/3TC + EFV
|Any ≥ Grade 3 Laboratory Abnormality||30%||26%|
|Fasting Cholesterol ( > 240 mg/dL)||22%||24%|
|Creatine Kinase (M: > 990 U/L) (F: > 845 U/L)||9%||7%|
|Serum Amylase ( > 175 U/L)||8%||4%|
|Alkaline Phosphatase ( > 550 U/L)||1%||0%|
|AST (M: > 180 U/L) (F: > 170 U/L)||3%||3%|
|ALT (M: > 215 U/L) (F: > 170 U/L)||2%||3%|
|Hemoglobin ( < 8.0 mg/dL)||0%||4%|
|Hyperglycemia ( > 250 mg/dL)||2%||1%|
|Hematuria ( > 75 RBC/HPF)||3%||2%|
|Glycosuria ( ≥ 3+)||< 1%||1%|
|3 Neutrophils ( < 750/mm³ )||3%||5%|
|Fasting Triglycerides ( > 750 mg/dL)||4%||2%|
|a From Weeks 96 to 144 of the trial, subjects received emtricitabine/tenofovir DF administered in combination with efavirenz in place of emtricitabine + tenofovir DF with efavirenz.|
Laboratory abnormalities observed in Study 073 were generally consistent with those in Study 934.
In addition to the laboratory abnormalities described for Study 934 (Table 3), Grade 3/4 laboratory abnormalities of increased bilirubin (greater than 2.5 x upper limit of normal (ULN)), increased pancreatic amylase (greater than 2.0 x ULN), increased or decreased serum glucose (less than 40 or greater than 250 mg/dL), and increased serum lipase (greater than 2.0 x ULN) occurred in up to 3% of subjects treated with emtricitabine or tenofovir DF with other antiretroviral agents in clinical trials.
Hepatic Events: In Study 934, 19 subjects treated with efavirenz, emtricitabine, and tenofovir DF and 20 subjects treated with efavirenz and fixed-dose zidovudine/lamivudine were hepatitis B surface antigen or hepatitis C antibody positive. Among these coinfected subjects, one subject (1/19) in the efavirenz, emtricitabine and tenofovir DF arm had elevations in transaminases to greater than five times ULN through 144 weeks. In the fixed-dose zidovudine/lamivudine arm, two subjects (2/20) had elevations in transaminases to greater than five times ULN through 144 weeks. No HBV and/or HCV coinfected subject discontinued from the trial due to hepatobiliary disorders [See WARNINGS AND PRECAUTIONS].
The following adverse reactions have been identified during postapproval use of efavirenz, emtricitabine, or tenofovir DF. Because postmarketing reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac Disorders - Palpitations
Endocrine Disorders - Gynecomastia
Eye Disorders - Abnormal vision
Gastrointestinal Disorders - Constipation, malabsorption
General Disorders and Administration Site Conditions- Asthenia
Hepatobiliary Disorders - Hepatic enzyme increase, hepatic failure, hepatitis. A few of the postmarketing reports of hepatic failure, including cases in patients with no pre-existing hepatic disease or other identifiable risk factors, were characterized by a fulminant course, progressing in some cases to transplantation or death.
Immune System Disorders - Allergic reactions
Musculoskeletal and Connective Tissue Disorders - Arthralgia, myalgia, myopathy
Respiratory, Thoracic and Mediastinal Disorders - Dyspnea
No postmarketing adverse reactions have been identified for inclusion in this section.
Tenofovir Disoproxil Fumarate
Immune System Disorders - Allergic reaction, including angioedema
Respiratory, Thoracic, and Mediastinal Disorders - Dyspnea
Gastrointestinal Disorders - Pancreatitis, increased amylase, abdominal pain
Hepatobiliary Disorders - Hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT, gamma GT)
Skin and Subcutaneous Tissue Disorders - Rash
Renal and Urinary Disorders - Acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
General Disorders and Administration Site Conditions - Asthenia
The following adverse reactions, listed under the body system headings above, may occur as a consequence of proximal renal tubulopathy: rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, hypophosphatemia.
Read the entire FDA prescribing information for Atripla (Efavirenz, Emtricitabine, and Tenofovir Disoproxil Fumarate) »
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