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Note: This document contains side effect information about bosentan. Some of the dosage forms listed on this page may not apply to the brand name Tracleer.
Common side effects of Tracleer include: increased serum alanine aminotransferase and increased serum aspartate aminotransferase. Other side effects include: decreased hematocrit, decreased hemoglobin, hepatic insufficiency, hypotension, palpitations, and flushing. See below for a comprehensive list of adverse effects.
Applies to bosentan: oral tablet, oral tablet for suspension
Oral route (Tablet; Tablet for Suspension)
Use of bosentan may result in hepatotoxicity or liver failure. Measure serum aminotransferase levels prior to initiation of treatment and then monthly. Stop treatment if liver aminotransferase elevations are accompanied by clinical symptoms of hepatotoxicity, or increases in bilirubin greater than or equal to 2 times ULN occur. Use of bosentan is likely to produce major birth defects if used by pregnant women. Exclude pregnancy before initiation of therapy and prevent pregnancy thereafter by the use of 2 forms of reliable contraception for the duration of treatment and for 1 month after stopping bosentan. If the patient has an intrauterine device (IUD) or tubal sterilization, no other contraception is needed. Monthly pregnancy tests should be obtained. Bosentan may be prescribed only through the Tracleer® REMS Program.
Along with its needed effects, bosentan (the active ingredient contained in Tracleer) 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 bosentan:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking bosentan:
Symptoms of overdose
Some side effects of bosentan 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:
Applies to bosentan: oral tablet, oral tablet dispersible
The most frequently reported side effects were headache, respiratory tract infection, anemia, decreased sperm count, and fluid retention/edema.
Very common (10% or more): Liver function test abnormal (up to 10.9%)
Common (1% to 10%): ALT increased, AST increased, hepatic enzyme increased
Frequency not reported: Hepatotoxicity
Postmarketing reports: Hepatic cirrhosis, liver failure, jaundice
Very common (10% or more): Headache (up to 15%)
Common (1% to 10%): Syncope
Very common (10% or more): Respiratory tract infection (up to 22%)
Common (1% to 10%): Sinusitis, nasal congestion, upper respiratory tract infection, lower respiratory tract infection, sinus congestion, rhinitis, oropharyngeal pain, epistaxis, nasopharyngitis, idiopathic pulmonary fibrosis
Very common (10% or more): Hemoglobin decreased (up to 57%)
Common (1% to 10%): Anemia, hematocrit decreased
Postmarketing reports: Thrombocytopenia, transfusion, neutropenia, leukopenia
Common (1% to 10%): Flushing, hypotension, palpitation, orthostatic hypotension, unstable angina, hot flush
Common (1% to 10%): Gastroesophageal reflux disease, diarrhea
Common (1% to 10%): Pruritus, erythema
Postmarketing reports: Angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), rash, dermatitis
Very common (10% or more): Sperm count decreased (25%)
Common (1% to 10%): Arthralgia, joint swelling
Common (1% to 10%): Vision blurred
Very common (10% or more): Edema/fluid retention (up to 13.2%)
Common (1% to 10%): Chest pain, peripheral edema, influenza-like illness, vertigo, pyrexia, chest pain
Common (1% to 10%): Hypersensitivity reaction
Postmarketing reports: Anaphylaxis