Note: This document contains side effect information about atazanavir. Some of the dosage forms listed on this page may not apply to the brand name Reyataz.
Applies to atazanavir: oral capsule, oral powder
Along with its needed effects, atazanavir (the active ingredient contained in Reyataz) 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
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:
Incidence not known
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.
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
Elevated total bilirubin (at least 2.6 times the upper limit of normal [2.6 x ULN]), ALT (at least 5.1 x ULN), and AST (at least 5.1 x 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.
Elevated total cholesterol (at least 240 mg/dL) and triglycerides (at least 751 mg/dL) have been reported in up to 25% and up to 8% of patients, respectively.
Very common (10% or more): Elevated total cholesterol (up to 25%)
Common (1% to 10%): Elevated triglycerides, fever/pyrexia, pain, fatigue, asthenia, lipodystrophy syndrome
Uncommon (0.1% to 1%): Chest pain, malaise, gait disturbances, decreased weight, weight gain
Rare (less than 0.1%): Edema
Frequency not reported: Elevated low-density lipoprotein cholesterol, elevated high-density lipoprotein cholesterol, burning sensation, dysplasia, facial atrophy, generalized edema, heat sensitivity, infection, overdose, pallor, peripheral edema, substernal chest pain, sweating, semicircular canal lithiasis
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
Elevated amylase (at least 2.1 x ULN) and lipase (at least 2.1 x 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
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
Elevated creatine kinase (at least 5.1 x ULN) has been reported in up to 11% of patients.
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
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.
Elevated glucose (at least 251 mg/dL) has been reported in 5% of patients.
Common (1% to 10%): Elevated glucose
Uncommon (0.1% to 1%): Anorexia, increased appetite
Rare (less than 0.1%): Ketoacidosis
Frequency not reported: 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
Common (1% to 10%): Depression, insomnia
Uncommon (0.1% to 1%): Anxiety, disorientation, sleep disorder, abnormal dream
Common (1% to 10%): Scleral icterus/ocular icterus
Common (1% to 10%): Increased cough
Uncommon (0.1% to 1%): Dyspnea
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 (the active ingredient contained in Reyataz) 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
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, granulomatous interstitial nephritis, chronic kidney disease
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%.
Postmarketing reports of chronic kidney disease in HIV-infected patients using this drug (with or without ritonavir) included biopsy-proven cases of granulomatous interstitial nephritis associated with deposition of atazanavir crystals in renal parenchyma.
Uncommon (0.1% to 1%): Hypersensitivity
Frequency not reported: Allergic reaction
Uncommon (0.1% to 1%): Hematuria, frequency of micturition/pollakiuria, proteinuria, gynecomastia
Frequency not reported: Decreased male fertility
Frequency not reported: Immune reconstitution syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome)
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Reyataz (www.drugs.com/reyataz.html).
March 28, 2020
March 28, 2020
March 28, 2020
March 28, 2020
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March 28, 2020