Atazanavir Side Effects

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.

For the Consumer

Applies to atazanavir: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking atazanavir: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Atazanavir may increase your risk of certain infections or autoimmune disorders by changing the way your immune system works. Symptoms may occur weeks or months after you start treatment with atazanavir. Tell your doctor if you have:

• signs of a new infection--fever, night sweats, swollen glands, diarrhea, stomach pain, weight loss;

• chest pain (especially when you breathe), dry cough, wheezing, feeling short of breath;

• cold sores, sores on your genital or anal area;

• rapid heart rate, feeling anxious or irritable, weakness or prickly feeling, problems with balance or eye movement;

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

• swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence, loss of interest in sex.

Stop taking atazanavir and call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• severe pain in your side or lower back, painful urination, blood in your urine;

• jaundice (yellowing of the skin or eyes);

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, stomach pain;

• muscle pain, mild itching or rash;

• headache, dizziness, depressed mood, sleep problems (insomnia);

• numbness or burning pain in your hands or 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 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), angioedema, photosensitivity
Postmarketing reports: Pruritus, alopecia, maculopapular rash

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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