Atazanavir Side Effects

Not all side effects for atazanavir may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to atazanavir: oral capsule, oral powder

In addition to its needed effects, some unwanted effects may be caused by atazanavir. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking atazanavir:

Incidence not known
  • Abdominal or stomach discomfort, fullness, or pain
  • bloating
  • blood in the urine
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • constipation
  • dark colored urine
  • decreased appetite
  • diarrhea
  • dizziness or lightheadedness
  • dry mouth
  • fainting
  • fast heartbeat
  • fast, shallow breathing
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • gaseous abdominal or stomach pain
  • general feeling of discomfort
  • headache
  • hives, itching, or skin rash
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • irregular heartbeat
  • loss of appetite
  • loss of consciousness
  • muscle pain or cramping
  • nausea
  • pain in the groin or genitals
  • pain in the stomach, side, or abdomen, possibly radiating to the back
  • recurrent fever
  • severe nausea or vomiting
  • sharp back pain just below the ribs
  • sleepiness
  • slow or irregular heartbeat
  • stomachache
  • sweating
  • swelling
  • tightness in the chest
  • trouble with breathing
  • unexplained weight loss
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting
  • vomiting of blood
  • yellow eyes or skin

Some of the side effects that can occur with atazanavir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Back pain
  • cough, increased
  • discouragement
  • extra body fat
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • trouble concentrating
  • trouble sleeping
Less common
  • Burning, numbness, tingling, or painful sensations
  • difficulty with moving
  • muscle stiffness
  • pain
  • pain in the joints
  • sleeplessness
  • unable to sleep
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Incidence not known
  • Hair loss or thinning of the hair
  • rash with flat lesions or small raised lesions on the skin

For Healthcare Professionals

Applies to atazanavir: oral capsule

General

The most common side effects reported in therapy-naive patients during clinical trials were nausea, jaundice/scleral icterus, and rash. The most common side effects reported in therapy-experienced patients during clinical trials were jaundice/scleral icterus and myalgia.

Hepatic

Elevated total bilirubin (at least 2.6 times upper limit of normal [ULN]), ALT (at least 5.1 times ULN), and AST (at least 5.1 times ULN) have been reported in up to 53%, up to 25%, and up to 10% of patients, respectively.

Most patients taking this drug experienced asymptomatic elevations in indirect (unconjugated) bilirubin related to inhibition of UDP-glucuronosyl transferase. This hyperbilirubinemia was reversible upon discontinuation of this drug.

Very common (10% or more): Elevated indirect (unconjugated) bilirubin (up to 87%), elevated total bilirubin (up to 53%), elevated ALT (up to 25%), jaundice (up to 19%)
Common (1% to 10%): Elevated AST, jaundice/scleral icterus
Uncommon (0.1% to 1%): Hepatitis
Rare (less than 0.1%): Hepatosplenomegaly
Frequency not reported: Hepatomegaly, liver damage, acute hepatic cytolysis, biliary lithiasis, choledocholithiasis
Postmarketing reports: Hepatic function abnormalities, cholelithiasis, cholecystitis, cholestasis

Metabolic

Elevated total cholesterol (at least 240 mg/dL), triglycerides (at least 751 mg/dL), and glucose (at least 251 mg/dL) have been reported in up to 25%, up to 8%, and 5% of patients.

Very common (10% or more): Elevated total cholesterol (up to 25%)
Common (1% to 10%): Elevated triglycerides, elevated glucose
Uncommon (0.1% to 1%): Anorexia, increased appetite, decreased weight, weight gain
Rare (less than 0.1%): Ketoacidosis
Frequency not reported: Elevated LDL cholesterol, elevated HDL cholesterol, hyperkalemia, lactic acidosis, hyperlactatemia, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance"), hypertriglyceridemia, hypercholesterolemia, insulin resistance
Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia

Dermatologic

Very common (10% or more): Rash (up to 20%)
Common (1% to 10%): Lipodystrophy
Uncommon (0.1% to 1%): Alopecia, pruritus, urticaria
Rare (less than 0.1%): Vesiculobullous rash, eczema
Frequency not reported: Photosensitivity
Postmarketing reports: Maculopapular rash, erythema multiforme, toxic skin eruptions, drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, angioedema, Stevens-Johnson syndrome

Gastrointestinal

Elevated amylase (at least 2.1 times ULN) and lipase (at least 2.1 times ULN) have been reported in up to 14% and up to 11% of patients, respectively.

Very common (10% or more): Nausea (up to 20%), elevated amylase (up to 14%), elevated lipase (up to 11%)
Common (1% to 10%): Abdominal pain, diarrhea, vomiting, dyspepsia
Uncommon (0.1% to 1%): Dry mouth, flatulence, gastritis, pancreatitis, abdominal distension, aphthous stomatitis
Frequency not reported: Acholia, colitis, constipation, dental pain, esophageal ulcer, gastrointestinal disorder, peptic ulcer, sialolithiasis/parotid gland lithiasis

Nervous system

Very common (10% or more): Headache (up to 14%)
Common (1% to 10%): Peripheral neurological symptoms, dizziness
Uncommon (0.1% to 1%): Syncope, peripheral neuropathy, amnesia, somnolence, dysgeusia
Frequency not reported: Paresthesias

Musculoskeletal

Very common (10% or more): Elevated creatine kinase (up to 11%)
Common (1% to 10%): Back pain, myalgia, arthralgia
Uncommon (0.1% to 1%): Muscle atrophy
Rare (less than 0.1%): Myopathy
Frequency not reported: Bone pain, extremity pain, myasthenia, osteonecrosis

Elevated creatine kinase (at least 5.1 times ULN) has been reported in up to 11% of patients.

Hematologic

Common (1% to 10%): Decreased neutrophils, decreased hemoglobin, decreased platelets
Rare (less than 0.1%): Spontaneous bleeding in hemophiliacs

Decreased neutrophils (less than 750 cells/mm3), hemoglobin (less than 8 g/dL), and platelets (less than 50,000 cells/mm3) have been reported in up to 8%, up to 5%, and up to 5% of patients, respectively.

Other

Common (1% to 10%): Fever/pyrexia, pain, fatigue, asthenia, lipodystrophy syndrome
Uncommon (0.1% to 1%): Chest pain, malaise, gait disturbances
Rare (less than 0.1%): Edema
Frequency not reported: Burning sensation, dysplasia, facial atrophy, generalized edema, heat sensitivity, infection, overdose, pallor, peripheral edema, substernal chest pain, sweating, semicircular canal lithiasis

Psychiatric

Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Anxiety, disorientation, sleep disorder, abnormal dream

Ocular

Common (1% to 10%): Scleral icterus/ocular icterus

Respiratory

Common (1% to 10%): Increased cough
Uncommon (0.1% to 1%): Dyspnea

Cardiovascular

In healthy volunteers and patients, abnormalities in AV conduction were asymptomatic and generally limited to first-degree AV block.

A 59-year-old HIV-infected woman with congestive heart failure and an ejection fraction of 30% started lamivudine, zidovudine, and atazanavir. One month later, the patient presented with syncope and complained of nausea, which had begun 5 days prior. During the month after therapy initiation, the patient experienced slowly progressive shortness of breath. An ECG showed a QTc interval prolongation of 619 min. Prior to starting antiretroviral therapy, an ECG showed a QTc interval of 398 min for the patient. The patient developed continuous ventricular tachycardia and was defibrillated to sinus bradycardia, which worsened her QT interval prolongation. The patient developed torsades de pointes, which reverted after further defibrillation. Treatment to increase her heart rate and decrease her QT interval was started. The patient's antiretroviral therapy was discontinued during her hospitalization and was not restarted due to concerns regarding QT prolongation. The patient's QTc interval decreased to 394 min and she had no additional ventricular tachyarrhythmias. The patient was restarted on lamivudine, zidovudine, and atazanavir and within 2 days, ECG showed QTc interval prolongation to 571 min. The atazanavir was concluded to be the cause of the prolonged QT interval and torsades de pointes. The patient's QT interval returned to normal following discontinuation of her antiretroviral therapy.

Uncommon (0.1% to 1%): Hypertension
Rare (less than 0.1%): Palpitation, vasodilatation
Frequency not reported: Prolongation of the PR interval, abnormalities in atrioventricular (AV) conduction, first-degree AV block, prolonged QT interval, ventricular tachycardia, increased QRS interval, heart arrest, heart block, myocarditis
Postmarketing reports: Second-degree AV block, third-degree AV block, left bundle branch block, QTc prolongation, torsades de pointes

Renal

Uncommon (0.1% to 1%): Interstitial nephritis
Rare (less than 0.1%): Acute interstitial nephritis, renal colic, reversible acute renal failure, urolithiasis, kidney pain
Postmarketing reports: Nephrolithiasis, hydronephrosis, renal insufficiency

An analysis of a ureteral stone determined it was 60% atazanavir metabolite and 40% calcium phosphate (carbonate apatite). The stone was not metabolites adsorbed into the apatite but contained atazanavir crystals. Analysis of renal calculi from additional patients determined concentrations of atazanavir ranging from 40% to 100%.

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Allergic reaction

Genitourinary

Uncommon (0.1% to 1%): Hematuria, frequency of micturition/pollakiuria, proteinuria, gynecomastia
Frequency not reported: Decreased male fertility

Immunologic

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

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