Reyataz Side Effects

Please note - some side effects for Reyataz may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Reyataz - for the Consumer

Reyataz

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Reyataz:

Changes in body fat; cough; diarrhea; fatigue; headache; increased cough; muscle pain; nausea; pain; stomach pain; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; chest pain; dizziness; fever, chills, or sore throat; increased urination or thirst; irregular heartbeat; lightheadedness; mental or mood changes (eg, depression); numbness, tingling, or extreme weakness especially in the arms or legs; painful urination; red, blistered, or swollen skin; severe nausea or vomiting; severe stomach or side pain; trouble breathing; unusual bleeding or bruising; yellowing of skin or eyes.

Reyataz Side Effects - for the Professional

Reyataz

Most common adverse reactions (≥2%) are nausea, jaundice/scleral icterus, rash, headache, abdominal pain, vomiting, insomnia, peripheral neurologic symptoms, dizziness, myalgia, diarrhea, depression, and fever. (6.1, 6.2)

Side Effects by Body System

Cardiovascular

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.

Cardiovascular side effects have included heart arrest, heart block, hypertension, myocarditis, palpitation, syncope, vasodilatation, and prolongation of the PR interval. Prolonged QT interval, ventricular tachycardia, torsades de pointes, and increased QRS interval have also been reported. In postmarketing experience second degree AV block, third degree AV block, left bundle branch block, and QTc prolongation have been reported.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain, acholia, anorexia, aphthous stomatitis, colitis, constipation, dental pain, diarrhea, dyspepsia, esophageal ulcer, gastritis, gastrointestinal disorder, nausea, vomiting, pancreatitis, and peptic ulcer. In postmarketing experience pancreatitis was reported.

Endocrine

Endocrine side effects have included decreased male fertility. In postmarketing experience, new onset and exacerbation of existing diabetes mellitus have been reported.

Musculoskeletal

Musculoskeletal side effects have included bone pain, extremity pain, muscle atrophy, myalgia, myasthenia, and myopathy. In postmarketing experience arthralgia has been reported.

Nervous system

Nervous system side effects have included depression, insomnia, dizziness, paresthesias, and peripheral neurological symptoms.

Respiratory

Respiratory side effects have included increased cough.

Hepatic

Hepatic side effects have included hepatitis, hepatomegaly, liver damage, jaundice/scleral icterus, and elevations of AST (greater than or equal to 5.1 times ULN), ALT (greater than or equal to 5.1 times ULN), total bilirubin (greater than or equal to 2.6 times ULN), amylase (greater than or equal to 2.1 times ULN), and lipase (greater than or equal to 2.1 times ULN). Acute hepatic cytolysis has also been reported. Monitoring of liver function is recommended in patients with a history of hepatitis B or C. In postmarketing experience hepatic function abnormalities, cholelithiasis, cholecystitis, and cholestasis have been reported.

Dermatologic

Dermatologic side effects have included rash, Stevens-Johnson syndrome, erythema multiforme, toxic skin eruptions, and photosensitivity. In postmarketing experience pruritus, alopecia, and maculopapular rash have been reported.

Metabolic

Metabolic side effects have included elevations of creatine kinase (greater than or equal to 5.1 times ULN), glucose (greater than 250 mg/dL), total cholesterol (greater than or equal to 240 mg/dL), LDL cholesterol, HDL cholesterol, and triglycerides (greater than or equal to 751 mg/dL). Ketoacidosis (rare), hyperkalemia, lactic acidosis, and symptomatic hyperlactatemia have also been reported. In postmarketing experience hyperglycemia has been reported.

Hematologic

Hematologic side effects have included decreases in hemoglobin (less than 8 g/dL), neutrophils (less than 750 cells/mm3), and platelets (less than 750 cells/mm3). Spontaneous bleeding in hemophiliacs has been reported rarely.

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%.

Renal side effects have rarely included acute interstitial nephritis, renal colic, reversible acute renal failure, and urolithiasis. Nephrolithiasis, hydronephrosis, and renal insufficiency have been reported in postmarketing experience.

Other

Redistribution and accumulation of body fat including central obesity, dorsocervical fat enlargement, peripheral wasting, facial wasting, breast enlargement and cushingoid appearance have been observed in patients receiving antiretroviral therapy.

Immunologic

Immunologic side effects have included immune reconstitution syndrome. Patients may develop inflammatory reactions to underlying or indolent opportunistic infections.

Other

Other side effects have included angioedema, asthenia, burning sensation, chest pain, dysplasia, edema, facial atrophy, fatigue, fever, generalized edema, headache, heat sensitivity, infection, malaise, overdose, pallor, peripheral edema, substernal chest pain, and sweating. In postmarketing experience edema was reported.

Hypersensitivity

Hypersensitivity reactions have been reported.

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