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Atripla

Generic Name: efavirenz, emtricitabine, and tenofovir (ef AV ir enz, em trye SYE ta been, and ten OF oh vir)
Brand Names: Atripla
Atripla prevents the human immunodeficiency virus (HIV) from reproducing in your body. Learn about side effects, interactions and indications.
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Drug Information:
Atripla contains a combination of efavirenz, emtricitabine, and tenofovir. Efavirenz, emtricitabine, and tenofovir are antiviral medications that prevent human immunodeficiency virus (HIV) from reproducing in your body. Atripla is used to treat HIV, the virus that can cause acquired immunodeficiency syndrome (AIDS). This medicine is not a cure for HIV or AIDS. Atripla is for use in adults and children who are at least 12 years old and weigh at least 88 pounds (40 kilograms). Do not take Atripla together with adefovir, atazanavir, voriconazole, or medications that contain emtricitabine, lamivudine, or tenofovir. Learn more

Atripla Side Effects

Atripla Side Effects

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.

In Summary

Common side effects of Atripla include: dizziness, insomnia, and skin rash. Other side effects include: drowsiness, lack of concentration, and abnormal dreams. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to efavirenz/emtricitabine/tenofovir: oral tablet

Warning

Oral route (Tablet)

Severe acute exacerbations of hepatitis B virus (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), which are components of efavirenz / emtricitabine / tenofovir disoproxil fumarate. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue efavirenz / emtricitabine / tenofovir disoproxil fumarate. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Along with its needed effects, efavirenz / emtricitabine / tenofovir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking efavirenz / emtricitabine / tenofovir:

Less common

  • Blistering, peeling, or loosening of the skin
  • body aches or pain
  • chills
  • clay-colored stools
  • cough
  • dark urine
  • ear congestion
  • fever
  • headache
  • itching
  • loss of voice
  • muscle aches
  • nausea
  • severe skin rash
  • sore throat
  • stomach pain or tenderness
  • swelling of the feet or lower legs
  • tightness of the chest
  • trouble concentrating
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Some side effects of efavirenz / emtricitabine / tenofovir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Diarrhea
  • dizziness

Less common

  • Abnormal dreams
  • decreased appetite
  • decreased awareness or responsiveness
  • discouragement
  • feeling sad or empty
  • irritability
  • loss of appetite
  • loss of interest or pleasure
  • mild rash
  • mimicry of speech or movements
  • mutism
  • negativism
  • pain or tenderness around the eyes and cheekbones
  • peculiar postures or movements, mannerisms or grimacing
  • severe sleepiness
  • trouble sleeping
  • unusual drowsiness

For Healthcare Professionals

Applies to efavirenz / emtricitabine / tenofovir: oral tablet

General

The most common side effects reported with this drug were psychiatric disorders, nervous system disorders, and gastrointestinal disorders. During a clinical trial using the individual components, the most common side effects were diarrhea, nausea, headache, fatigue, dizziness, depression, insomnia, abnormal dreams, and rash.

In general, the most common side effects associated with efavirenz in combination with other antiretroviral drugs of at least moderate severity included rash, dizziness, nausea, headache, and fatigue; the most significant side effects were nervous system symptoms, psychiatric symptoms, and rash.

In general, the most common side effects associated with emtricitabine in combination with other antiretroviral drugs of mild to moderate severity included headache, diarrhea, nausea, and rash; mild and asymptomatic skin discoloration (hyperpigmentation on the palms and/or soles) occurred more often with emtricitabine than the control treatment.

In general, the most common side effects associated with tenofovir in combination with other antiretroviral drugs were mild to moderate gastrointestinal events, including nausea, diarrhea, vomiting, and flatulence.

Metabolic

Elevated fasting cholesterol (greater than 240 mg/dL), elevated fasting triglycerides (greater than 750 mg/dL), altered serum glucose (less than 40 mg/dL or greater than 250 mg/dL), hyperglycemia (greater than 250 mg/dL), and elevated alkaline phosphatase (greater than 550 units/L) have been reported in up to 22%, 4%, up to 3%, up to 2%, and 1% of patients, respectively.

Hypercholesterolemia and hypertriglyceridemia have also been reported during postmarketing experience with efavirenz.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with the use of nucleoside analogs.

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

Hypokalemia, lactic acidosis, and hypophosphatemia have also been reported during postmarketing experience with tenofovir.

Very common (10% or more): Elevated fasting cholesterol (up to 22%)

Common (1% to 10%): Anorexia, elevated fasting triglycerides, altered serum glucose, hyperglycemia, elevated alkaline phosphatase

Uncommon (0.1% to 1%): Increased appetite

Efavirenz:

-Common (1% to 10%): Anorexia, hypertriglyceridemia

-Uncommon (0.1% to 1%): Hypercholesterolemia

-Postmarketing reports: Redistribution/accumulation of body fat (in areas such as back of neck, breasts, abdomen, retroperitoneum)

Emtricitabine:

-Common (1% to 10%): Hyperglycemia, hypertriglyceridemia

Tenofovir:

-Very common (10% or more): Hypophosphatemia

-Uncommon (0.1% to 1%): Hypokalemia

-Rare (less than 0.1%): Lactic acidosis

Combination antiretroviral therapy:

-Frequency not reported: Metabolic abnormalities (e.g., hypertriglyceridemia, hypercholesterolemia, insulin resistance, hyperglycemia, hyperlactatemia), redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")

Gastrointestinal

Common (1% to 10%): Diarrhea, nausea, elevated serum amylase, vomiting

Uncommon (0.1% to 1%): Dry mouth

Emtricitabine or tenofovir:

-Common (1% to 10%): Dyspepsia, abdominal pain, elevated pancreatic amylase, elevated serum lipase

Efavirenz:

-Common (1% to 10%): Dyspepsia, abdominal pain, diarrhea, vomiting, nausea

-Uncommon (0.1% to 1%): Pancreatitis

-Postmarketing reports: Constipation, malabsorption

Emtricitabine:

-Very common (10% or more): Diarrhea, nausea

-Common (1% to 10%): Elevated amylase (including elevated pancreatic amylase), elevated serum lipase, vomiting, abdominal pain, dyspepsia

Tenofovir:

-Very common (10% or more): Diarrhea, vomiting, nausea

-Common (1% to 10%): Abdominal pain, abdominal distension, flatulence

-Uncommon (0.1% to 1%): Pancreatitis

-Postmarketing reports: Increased amylase

Elevated serum amylase (greater than 175 units/L) has been reported in up to 8% of patients.

Elevated pancreatic amylase (greater than 2 x ULN) and serum lipase (greater than 2 x ULN) have each been reported with emtricitabine or tenofovir in up to 3% of patients.

Pancreatitis and abdominal pain have also been reported during postmarketing experience with efavirenz and tenofovir.

Psychiatric

Serious psychiatric side effects associated with efavirenz have included severe depression, suicidal ideation, nonfatal suicide attempts, aggression, paranoia, and mania.

Aggression, agitation, affect lability, psychosis, paranoia, and mania have also been reported during postmarketing experience with efavirenz.

Common (1% to 10%): Depression, anxiety, insomnia

Uncommon (0.1% to 1%): Decreased libido

Efavirenz:

-Very common (10% or more): Insomnia (up to 16.3%)

-Common (1% to 10%): Depression, anxiety, severe depression, abnormal dreams, nervousness, hallucination

-Uncommon (0.1% to 1%): Suicidal ideation, nonfatal suicide attempts, aggression, paranoia, mania, psychosis, euphoric mood, affect/emotional lability, confusional state, agitation

-Frequency not reported: Depersonalization, delirium

-Postmarketing reports: Delusions, neurosis, psychosis-like behavior, completed suicide

Emtricitabine:

-Common (1% to 10%): Insomnia, abnormal dreams

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Incoherent speech

Emtricitabine or tenofovir:

-Common (1% to 10%): Paresthesia, peripheral neuropathy (including peripheral neuritis and neuropathy)

Efavirenz:

-Very common (10% or more): Nervous system symptoms (53%), dizziness (up to 28.1%)

-Common (1% to 10%): Impaired concentration, somnolence, cerebellar coordination and balance disturbances, headache, disturbance in attention

-Uncommon (0.1% to 1%): Convulsions, amnesia, abnormal thinking, ataxia, abnormal coordination, tremor, vertigo, tinnitus

-Frequency not reported: Stupor

-Postmarketing reports: Hypoesthesia, paresthesia, neuropathy

Emtricitabine:

-Very common (10% or more): Headache

-Common (1% to 10%): Dizziness

Tenofovir:

-Very common (10% or more): Dizziness

-Common (1% to 10%): Headache

Nervous system symptoms of any grade and regardless of causality (53%) included dizziness, insomnia, impaired concentration, somnolence, abnormal dreams, hallucinations, 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; generally began the first or second day of therapy and often resolved after 2 to 4 weeks. Therapy was discontinued in 2.1% of patients due to these side effects.

Abnormal coordination, ataxia, cerebellar coordination and balance disturbances, convulsions, tremor, tinnitus, and vertigo have also been reported during postmarketing experience with efavirenz.

Dermatologic

Rashes associated with efavirenz were usually mild-to-moderate maculopapular skin eruptions. The median time to onset of rash was 11 days. In most patients who continued therapy, the rash resolved within 1 month. Treatment was discontinued in 1.7% of patients due to rash.

There was limited experience using efavirenz in patients who previously discontinued other nonnucleoside reverse transcriptase inhibitors due to rash. In 19 such patients formerly on nevirapine, about half developed a mild to moderate rash; 2 of those patients discontinued efavirenz because of the rash.

Erythema multiforme, pruritus, photoallergic dermatitis, and Stevens-Johnson syndrome have also been reported during postmarketing experience with efavirenz. Rash has also been reported during postmarketing experience with tenofovir.

Common (1% to 10%): Rash event (including rash, exfoliative rash, generalized rash, macular rash, maculopapular rash, pruritic rash, vesicular rash)

Emtricitabine or tenofovir:

-Common (1% to 10%): Rash event (including rash, pruritus, maculopapular rash, urticaria, vesiculobullous rash, pustular rash, allergic reaction)

Efavirenz:

-Very common (10% or more): Skin rash of any grade (up to 26.3%), grade 2 rash (diffuse maculopapular rash, dry desquamation; 14.7%), grade 1 rash (erythema, pruritus; 10.7%)

-Common (1% to 10%): Pruritus

-Uncommon (0.1% to 1%): Grade 3 rash (vesiculation, moist desquamation, ulceration), grade 4 rash (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, necrosis requiring surgery, exfoliative dermatitis)

-Rare (less than 0.1%): Photoallergic dermatitis

-Frequency not reported: Nail disorders, skin discoloration, leukocytoclastic vasculitis

Emtricitabine:

-Common (1% to 10%): Vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discoloration (palmar-plantar hyperpigmentation)

-Postmarketing reports: Angioedema

Tenofovir:

-Very common (10% or more): Rash

-Rare (less than 0.1%): Angioedema

Other

Common (1% to 10%): Fatigue

Frequency not reported: Increased body weight

Emtricitabine or tenofovir:

-Common (1% to 10%): Fever, pain, back pain

Efavirenz:

-Common (1% to 10%): Pain, fatigue

-Uncommon (0.1% to 1%): Flushing

-Frequency not reported: False-positive urine cannabinoid test results

-Postmarketing reports: Contraceptive failure (with an implantable hormonal contraceptive), asthenia

Emtricitabine:

-Common (1% to 10%): Pain, asthenia

Tenofovir:

-Very common (10% or more): Asthenia

-Frequency not reported: Higher 1,25 vitamin D levels

False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV-infected patients receiving efavirenz.

Flushing and asthenia have also been reported during postmarketing experience with efavirenz and tenofovir, respectively.

Respiratory

Common (1% to 10%): Sinusitis, upper respiratory tract infections, nasopharyngitis

Emtricitabine or tenofovir:

-Common (1% to 10%): Increased cough, pneumonia, rhinitis

Efavirenz:

-Postmarketing reports: Dyspnea

Tenofovir:

-Postmarketing reports: Dyspnea

Hepatic

Elevated AST (greater than 180 units/L in males and 170 units/L in females) and ALT (greater than 215 units/L in males and 170 units/L in females) have been reported in 3% and 2% of patients, respectively.

AST and ALT elevations were reported more often in patients who were coinfected with hepatitis B or C than in patients without coinfection.

Elevated bilirubin (greater than 2.5 times the upper limit of normal [2.5 x ULN]) has been reported with emtricitabine or tenofovir in up to 3% of patients.

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.

Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) have been reported with nucleoside analogs.

Hepatic steatosis and hepatitis have also been reported during postmarketing experience with tenofovir.

Common (1% to 10%): Elevated AST, elevated ALT

Emtricitabine or tenofovir:

-Common (1% to 10%): Elevated bilirubin

-Frequency not reported: Severe acute exacerbations of hepatitis B

Efavirenz:

-Common (1% to 10%): Elevated ALT, elevated AST, elevated GGT

-Uncommon (0.1% to 1%): Acute hepatitis

-Postmarketing reports: Hepatic enzyme increase, hepatic failure (a few reports were characterized by a fulminant course, with some cases progressing to transplantation or death), hepatitis

Emtricitabine:

-Common (1% to 10%): Elevated serum AST and/or elevated serum ALT, hyperbilirubinemia

-Frequency not reported: Liver failure, liver decompensation

Tenofovir:

-Common (1% to 10%): Increased transaminases

-Rare (less than 0.1%): Hepatic steatosis, hepatitis

-Frequency not reported: Lactic acidosis/severe hepatomegaly with steatosis

-Postmarketing reports: Elevated liver enzymes (primarily AST, ALT, GGT)

Hematologic

Decreased neutrophils (less than 750/mm3) has been reported in 3% of patients.

Common (1% to 10%): Decreased neutrophils

Frequency not reported: Increased hemoglobin

Emtricitabine:

-Common (1% to 10%): Neutropenia

-Uncommon (0.1% to 1%): Anemia

Musculoskeletal

Elevated creatine kinase (greater than 990 units/L in males and 845 units/L in females) has been reported in up to 9% of patients.

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

Rhabdomyolysis, osteomalacia, muscular weakness, and myopathy have also been reported during postmarketing experience with tenofovir.

Common (1% to 10%): Elevated creatine kinase

Uncommon (0.1% to 1%): Myalgia

Emtricitabine or tenofovir:

-Common (1% to 10%): Arthralgia, myalgia

Emtricitabine:

-Very common (10% or more): Elevated creatine kinase

Efavirenz:

-Postmarketing reports: Arthralgia, myalgia, myopathy

Tenofovir:

-Uncommon (0.1% to 1%): Rhabdomyolysis, muscular weakness

-Rare (less than 0.1%): Myopathy, osteomalacia (manifested as bone pain and infrequently contributing to fractures)

-Frequency not reported: Decreased bone mineral density, increased biochemical markers of bone metabolism

Combination antiretroviral therapy:

-Frequency not reported: Osteonecrosis

Genitourinary

Common (1% to 10%): Hematuria

Uncommon (0.1% to 1%): Glycosuria

Tenofovir:

-Uncommon (0.1% to 1%): Proteinuria

-Postmarketing reports: Polyuria

Hematuria (greater than 75 red blood cells/high power field) and glycosuria (3+ or greater) have been reported in up to 3% and less than 1% of patients, respectively.

Proteinuria has also been reported during postmarketing experience with tenofovir.

Renal

Tenofovir:

-Uncommon (0.1% to 1%): Increased creatinine

-Rare (less than 0.1%): Renal failure (acute and chronic), acute tubular necrosis, proximal renal tubulopathy (including Fanconi syndrome), nephrogenic diabetes insipidus

-Frequency not reported: New onset or worsening renal impairment

-Postmarketing reports: Renal insufficiency, nephritis (including acute interstitial nephritis)

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

Renal failure, acute renal failure, Fanconi syndrome, proximal renal tubulopathy, increased creatinine, acute tubular necrosis, and nephrogenic diabetes insipidus have also been reported during postmarketing experience with tenofovir.

Immunologic

Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)

Efavirenz:

-Postmarketing reports: Immune reconstitution syndrome

Emtricitabine:

-Postmarketing reports: Immune reconstitution syndrome

Tenofovir:

-Postmarketing reports: Immune reconstitution syndrome

Hypersensitivity

Efavirenz:

-Uncommon (0.1% to 1%): Hypersensitivity

-Postmarketing reports: Allergic reactions

Emtricitabine:

-Common (1% to 10%): Allergic reaction

Tenofovir:

-Postmarketing reports: Allergic reaction (including angioedema)

Cardiovascular

Efavirenz:

-Frequency not reported: QT interval prolongation, torsades de pointes

-Postmarketing reports: Palpitations

Endocrine

Efavirenz:

-Uncommon (0.1% to 1%): Gynecomastia

Tenofovir:

-Frequency not reported: Higher serum parathyroid hormone levels

Gynecomastia has also been reported during postmarketing experience with efavirenz.

Ocular

Efavirenz:

-Uncommon (0.1% to 1%): Blurred vision

-Postmarketing reports: Abnormal vision

Blurred vision has also been reported during postmarketing experience with efavirenz.

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Atripla