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

Hepatic

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

Monitoring of liver function is recommended in patients with a history of hepatitis B or C.

Very common (10% or more): Asymptomatic elevations in indirect (unconjugated) bilirubin, elevated total bilirubin (greater than or equal to 2.6 times ULN: up to 49%), elevated ALT (greater than or equal to 5.1 times ULN: up to 25%)
Common (1% to 10%): Elevated AST (greater than or equal to 5.1 times ULN: up to 10%), jaundice/scleral icterus (moderate or severe intensity: up to 9%)
Rare (less than 0.1%): Biliary lithiasis (at least 1 case), choledocholithiasis (at least 1 case)
Frequency not reported: Hepatitis, hepatomegaly, liver damage, acute hepatic cytolysis
Postmarketing reports: Hepatic function abnormalities, cholelithiasis, cholecystitis, cholestasis

Metabolic

Very common (10% or more): Elevated total cholesterol (greater than or equal to 240 mg/dL: up to 25%)
Common (1% to 10%): Elevated triglycerides (greater than or equal to 751 mg/dL: up to 8%), elevated glucose (greater than or equal to 251 mg/dL: 5%)
Rare (less than 0.1%): Ketoacidosis
Frequency not reported: Elevated LDL cholesterol, elevated HDL cholesterol, hyperkalemia, lactic acidosis, symptomatic hyperlactatemia, redistribution/accumulation of body fat (including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement, "cushingoid appearance")
Postmarketing reports: New onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, hyperglycemia

Dermatologic

Very common (10% or more): Rash (all grades: up to 20%)
Common (1% to 10%): Rash (moderate or severe intensity: up to 7%)
Frequency not reported: Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions (including drug rash, eosinophilia, and systemic symptoms [DRESS] syndrome), photosensitivity
Postmarketing reports: Pruritus, alopecia, maculopapular rash, angioedema

Gastrointestinal

Very common (10% or more): Nausea (moderate or severe intensity: up to 14%), elevated amylase (greater than or equal to 2.1 times ULN: up to 14%)
Common (1% to 10%): Elevated lipase (greater than or equal to 2.1 times ULN: up to 5%), vomiting (moderate or severe intensity: up to 4%), abdominal pain (moderate or severe intensity: 4%), diarrhea (moderate or severe intensity: up to 3%)
Rare (less than 0.1%): Sialolithiasis/parotid gland lithiasis (at least 2 cases)
Frequency not reported: Acholia, anorexia, aphthous stomatitis, colitis, constipation, dental pain, dyspepsia, esophageal ulcer, gastritis, gastrointestinal disorder, peptic ulcer
Postmarketing reports: Pancreatitis

Musculoskeletal

Very common (10% or more): Elevated creatine kinase (greater than or equal to 5.1 times ULN: up to 11%)
Common (1% to 10%): Myalgia (moderate or severe intensity: 4%)
Frequency not reported: Bone pain, extremity pain, muscle atrophy, myasthenia, myopathy
Postmarketing reports: Arthralgia

Hematologic

Common (1% to 10%): Decreased neutrophils (less than 750 cells/mm3: up to 7%), decreased hemoglobin (less than 8 g/dL: up to 5%), decreased platelets (less than 50,000 cells/mm3: 2%)
Rare (less than 0.1%): Spontaneous bleeding in hemophiliacs

Nervous system

Common (1% to 10%): Headache (moderate or severe intensity: up to 6%), peripheral neurological symptoms (moderate or severe intensity: up to 4%), insomnia (moderate or severe intensity: up to 3%), dizziness (moderate or severe intensity: up to 2%)
Frequency not reported: Syncope, paresthesias

Cardiovascular

In healthy volunteers and patients, abnormalities in atrioventricular (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 following treatment initiation, the patient experienced slowly progressive shortness of breath. An electrocardiogram (EKG) showed a QTc interval prolongation of 619 min. Prior to starting antiretroviral treatment, an EKG 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 following further defibrillation. Treatment to increase her heart rate and decrease her QT interval was started. The patient's antiretroviral treatment 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, EKG 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 treatment.

Frequency not reported: Prolongation of the PR interval, abnormalities in AV conduction, first-degree AV block, prolonged QT interval, ventricular tachycardia, torsades de pointes, increased QRS interval, heart arrest, heart block, hypertension, myocarditis, palpitation, vasodilatation
Postmarketing reports: Second-degree AV block, third-degree AV block, left bundle branch block, QTc prolongation

Other

Common (1% to 10%): Fever (moderate or severe intensity: 2%)
Rare (less than 0.1%): Semicircular canal lithiasis (at least 1 case)
Frequency not reported: Asthenia, burning sensation, chest pain, dysplasia, facial atrophy, fatigue, generalized edema, heat sensitivity, infection, malaise, overdose, pallor, peripheral edema, substernal chest pain, sweating
Postmarketing reports: Edema

Psychiatric

Common (1% to 10%): Depression (moderate or severe intensity: 2%)

Renal

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%.

Rare (less than 0.1%): Acute interstitial nephritis, renal colic, reversible acute renal failure, urolithiasis
Postmarketing reports: Nephrolithiasis, interstitial nephritis, hydronephrosis, renal insufficiency

Hypersensitivity

Frequency not reported: Allergic reaction

Immunologic

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

Respiratory

Frequency not reported: Increased cough

Genitourinary

Frequency not reported: Decreased male fertility

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