Atripla Side Effects

Generic name: efavirenz / emtricitabine / tenofovir

Note: This document contains side effect information about efavirenz / emtricitabine / tenofovir. Some of the dosage forms listed on this page may not apply to the brand name Atripla.

Some side effects of Atripla may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to efavirenz / emtricitabine / tenofovir: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking efavirenz / emtricitabine / tenofovir: 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;

• pale skin, feeling light-headed or short of breath, trouble concentrating;

• rapid heart rate, increased sweating, tremors in your hands, anxiety, feeling irritable, sleep problems (insomnia);

• diarrhea, unexplained weight loss, menstrual changes, impotence, loss of interest in sex;

• swelling in your neck or throat (enlarged thyroid);

• weakness or prickly feeling in your fingers or toes;

• problems with walking, breathing, speech, swallowing, or eye movement;

• severe lower back pain, loss of bladder or bowel control;

• 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 of efavirenz / emtricitabine / tenofovir may include:

• mild nausea, vomiting, gas, upset stomach;

• headache, dizziness, drowsiness, 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.

For Healthcare Professionals

Applies to efavirenz / emtricitabine / tenofovir: oral tablet

General

The most common side effects (any severity; greater than or equal to 10%) reported during a clinical study of efavirenz, emtricitabine, and tenofovir included diarrhea, nausea, headache, fatigue, dizziness, depression, insomnia, abnormal dreams, and rash. The most significant side effects associated with efavirenz are nervous system symptoms, psychiatric symptoms, and rash.

Hepatic

Hepatic side effects have included elevated AST (greater than 180 units/L in males and 170 units/L in females; 3%) and ALT (greater than 215 units/L in males and 170 units/L in females; 2%). Elevated bilirubin (greater than 2.5 times ULN) has been reported in up to 3% of patients treated with emtricitabine or tenofovir. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with nucleoside analogs, including tenofovir, in combination with other antiretrovirals. Hepatic enzyme increase, hepatic failure (a few reports were characterized by a fulminant course, with some cases progressing to transplantation or death), and hepatitis have been reported during postmarketing experience with efavirenz. Hepatic steatosis, hepatitis, and increased liver enzymes (primarily AST, ALT, and gamma glutamyl transferase) have been reported during postmarketing experience with tenofovir. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and hepatitis B after discontinuation of emtricitabine or tenofovir and were associated with liver failure and liver decompensation in some of the emtricitabine-treated patients.

Some of the postmarketing reports of hepatic failure with efavirenz occurred in patients with no preexisting liver disease or other identifiable risk factors.

Gastrointestinal

Gastrointestinal side effects (Grades 2 to 4) have included diarrhea (9%), nausea (9%), and vomiting (2%). Selected side effects of moderate to severe intensity have included anorexia, dyspepsia, and abdominal pain in greater than or equal to 2% of efavirenz-treated patients. Pancreatitis has been reported with efavirenz, although causality was not determined. Dyspepsia and abdominal pain have been reported in at least 5% of patients receiving emtricitabine or tenofovir. Constipation and malabsorption have been reported during postmarketing experience with efavirenz. Pancreatitis, abdominal pain, and increased amylase have been reported during postmarketing experience with tenofovir.

Psychiatric

Psychiatric side effects (Grades 2 to 4) have included depression (9%), anxiety (5%), and insomnia (5%). Selected side effects of moderate to severe intensity have included abnormal dreams and nervousness in greater than or equal to 2% of efavirenz-treated patients. Serious psychiatric side effects associated with efavirenz have included severe depression (2.4%), suicidal ideation (0.7%), nonfatal suicide attempts (0.5%), aggressive behavior (0.4%), paranoid reactions (0.4%), and manic reactions (0.2%). Aggressive reactions, agitation, delusions, emotional lability, mania neurosis, paranoia, psychosis, and suicide have been reported during postmarketing experience with efavirenz.

Dermatologic

Dermatologic side effects (Grades 2 to 4) have included rash event (including rash, exfoliative rash, generalized rash, macular rash, maculopapular rash, pruritic rash, and vesicular rash; 7%). Selected side effects of moderate to severe intensity have included pruritus in greater than or equal to 2% of efavirenz-treated patients. In patients treated with 600 mg of efavirenz during clinical trials, skin rash of any grade (26%) included Grade 1 rash (erythema, pruritus; approximately 10%), Grade 2 rash (diffuse maculopapular rash, dry desquamation;,14.7%), Grade 3 rash (vesiculation, moist desquamation, ulceration; less than 1%), and Grade 4 rash (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis; 0.1%). Treatment was discontinued in 1.7% of patients due to rash. Nail disorders, skin discoloration, and leukocytoclastic vasculitis have also been reported with efavirenz. Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, and allergic reaction) has been reported in at least 5% of patients receiving emtricitabine or tenofovir. Skin discoloration (palmar-plantar hyperpigmentation) has been reported with emtricitabine. Erythema multiforme, photoallergic dermatitis, and Stevens-Johnson syndrome have been reported during postmarketing experience with efavirenz. Rash has also been reported during postmarketing experience with tenofovir.

Rashes associated with efavirenz are usually mild-to-moderate maculopapular skin eruptions. The median time to onset of rash was 11 days. In most patients, the rash resolved within one month despite continued use of the drug. Patients who discontinue efavirenz therapy because of rash may be reinstated with the use of appropriate antihistamines and/or corticosteroids. The drug should be withdrawn if severe rash develops, such as that associated with blistering, desquamation, mucosal involvement, or fever.

There is limited experience with the use of efavirenz in patients who have previously discontinued other nonnucleoside reverse transcriptase inhibitors (NNRTIs) due to rash. In 19 such patients formerly on nevirapine, approximately half developed a mild to moderate rash, and two of them discontinued efavirenz because of the rash.

Nervous system

Nervous system side effects (Grades 2 to 4) have included dizziness (8%) and headache (6%). Selected side effects of moderate to severe intensity have included impaired concentration and somnolence in greater than or equal to 2% of efavirenz-treated patients. Nervous system symptoms of any grade and regardless of causality (53%) included dizziness (28.1%), insomnia (16.3%), impaired concentration (8.3%), somnolence (7%), abnormal dreams (6.2%), hallucinations (1.2%), amnesia, agitation, euphoria, depersonalization, confusion, abnormal thinking, and stupor during clinical trials of efavirenz in combination with other antiretroviral agents. These symptoms were mild in 33.3%, moderate in 17.4%, and severe in 2% of patients. Therapy was discontinued in 2.1% of patients due to these side effects. Paresthesia and peripheral neuropathy (including peripheral neuritis and neuropathy) have been reported in at least 5% of patients receiving emtricitabine or tenofovir. Abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, hypoesthesia, paresthesia, neuropathy, tremor, vertigo, and tinnitus have been reported during postmarketing experience with efavirenz.

Other

Other side effects (Grades 2 to 4) have included fatigue (9%). Pain (moderate to severe intensity; 2% or greater) has been reported with efavirenz. Fever, pain, and back pain have been reported in at least 5% of patients receiving emtricitabine or tenofovir. Asthenia has been reported during postmarketing experience with efavirenz and tenofovir. Contraceptive failure (with an implantable hormonal contraceptive) has been reported during postmarketing experience with efavirenz.

Metabolic

Metabolic side effects have included hyperglycemia (greater than 250 mg/dL; up to 2%), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL; up to 3%), and elevated fasting cholesterol (greater than 240 mg/dL; up to 22%), creatine kinase (greater than 990 units/L in males and 845 units/L in females; up to 9%), serum amylase (greater than 175 units/L; up to 8%), fasting triglycerides (greater than 750 mg/dL; 4%), and alkaline phosphatase (greater than 550 units/L; 1%). Elevated pancreatic amylase (greater than 2 times ULN; up to 3%) and serum lipase (greater than 2 times ULN; up to 3%) have been reported in up to 3% of patients treated with emtricitabine or tenofovir. Increased body weight has also been reported. Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, and "cushingoid appearance" have been observed in patients receiving antiretroviral therapy. Hypercholesterolemia and hypertriglyceridemia have been reported during postmarketing experience with efavirenz. Hypokalemia, lactic acidosis, and hypophosphatemia have been reported during postmarketing experience with tenofovir.

Hypokalemia and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Respiratory

Respiratory side effects (Grades 2 to 4) have included sinusitis (8%), upper respiratory tract infections (8%), and nasopharyngitis (5%). Increased cough, pneumonia, and rhinitis have been reported in at least 5% of patients receiving emtricitabine or tenofovir. Dyspnea has been reported during postmarketing experience with efavirenz and tenofovir.

Renal

Renal side effects have included new onset or worsening renal impairment with tenofovir. Renal insufficiency, renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, acute tubular necrosis, nephrogenic diabetes insipidus, and interstitial nephritis (including acute cases) have been reported during postmarketing experience with tenofovir.

Rhabdomyolysis, osteomalacia, hypokalemia, muscular weakness, myopathy, and hypophosphatemia may occur as a result of proximal renal tubulopathy.

Hematologic

Hematologic side effects have included decreased neutrophils (less than 750/mm3; 3%). Increased hemoglobin has been reported.

Endocrine

Endocrine side effects have included gynecomastia during postmarketing experience with efavirenz.

Cardiovascular

Cardiovascular side effects have included flushing and palpitations during postmarketing experience with efavirenz. QT interval prolongation and torsades de pointes have been reported with efavirenz.

Musculoskeletal

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy may occur as a result of proximal renal tubulopathy.

Musculoskeletal side effects have included arthralgia and myalgia in at least 5% of patients receiving emtricitabine or tenofovir. Arthralgia, myalgia, and myopathy have been reported during postmarketing experience with efavirenz. Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, and myopathy have been reported during postmarketing experience with tenofovir.

Hypersensitivity

Hypersensitivity side effects have included allergic reactions during postmarketing experience with efavirenz. Allergic reaction (including angioedema) has been reported during postmarketing experience with tenofovir.

Ocular

Ocular side effects have included abnormal vision during postmarketing experience with efavirenz.

Genitourinary

Genitourinary side effects have included hematuria (greater than 75 RBC/HPF; up to 3%) and glycosuria (3 plus or greater; less than 1%). Proteinuria and polyuria have been reported during postmarketing experience with tenofovir.

Immunologic

Immunologic side effects have included immune reconstitution syndrome.

Other

False positive urine drug screening test results for tetrahydrocannabinol and benzodiazepines have been reported in HIV-infected patients receiving efavirenz. False positive cannabinoid test results have been observed with the CEDIA DAU Multilevel THC assay and the InstaCheck multidrug Screen Panel. The Triage 8 and the Drug Screen Multi 5 have shown false-positive results for benzodiazepines and tetrahydrocannabinol.

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