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Atazanavir Side Effects

For the Consumer

Applies to atazanavir: oral capsule, oral powder

Along with its needed effects, atazanavir 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 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 side effects of atazanavir 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
  • 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
  • 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, oral powder for reconstitution


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.[Ref]


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.[Ref]

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[Ref]


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.[Ref]

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[Ref]


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[Ref]


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.[Ref]

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[Ref]

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[Ref]


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[Ref]

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


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

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.[Ref]


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[Ref]


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


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


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


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.[Ref]

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[Ref]


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[Ref]

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%.[Ref]


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


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


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


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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.