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Tracleer

Generic Name: bosentan (boe SEN tan)
Brand Name: Tracleer
Physician reviewed Tracleer patient information - includes Tracleer description, dosage and directions.
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Drug Information:
Tracleer lowers blood pressure in your lungs, helping your heart pump blood more efficiently. Tracleer is used to treat pulmonary arterial hypertension (PAH) in adults and children who are at least 3 years old. It improves your ability to exercise and prevents your condition from getting worse. Tracleer is available only under a special program from a certified pharmacy. You must be registered in the program and understand the risks and benefits of taking this medication. Tracleer may also be used for purposes not listed in this medication guide. Learn more

Tracleer Side Effects

Tracleer Side Effects

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.

In Summary

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.

For the Consumer

Applies to bosentan: oral tablet, oral tablet for suspension

Warning

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:

More common

  • Blurred vision
  • confusion
  • dizziness
  • dark urine
  • faintness or lightheadedness when getting up from a lying or sitting position
  • fever with or without chills
  • light-colored stools
  • loss of appetite
  • nausea
  • stomach pain
  • sudden sweating
  • unusual tiredness or weakness
  • vomiting
  • yellow eyes or skin

Less common

  • Swelling

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blue lips and fingernails
  • chest pain
  • chills
  • clay-colored stools
  • coughing that sometimes produces a pink frothy sputum
  • coughing up blood
  • dark urine
  • decrease in the amount of urine
  • difficult, fast, or noisy breathing
  • fainting
  • fast heartbeat
  • fatigue on exertion
  • fever
  • headache
  • hives, itching, skin rash
  • hoarseness
  • increased sweating
  • irritation
  • joint pain, stiffness, or swelling
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • noisy, rattling breathing
  • pale skin
  • pinpoint red spots on the skin
  • redness of the skin
  • shortness of breath
  • swelling of the eyelids, face, lips, hands, fingers, legs, ankles, or feet
  • tightness in the chest
  • troubled breathing at rest or exertion
  • troubled breathing or swallowing
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking bosentan:

Symptoms of overdose

  • Increased heart rate

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:

More common

  • Fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • muscle aches
  • redness of the face, neck, arms, and occasionally upper chest
  • sore throat
  • stuffy or runny nose

Less common

  • Belching
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to bosentan: oral tablet, oral tablet dispersible

General

The most frequently reported side effects were headache, respiratory tract infection, anemia, decreased sperm count, and fluid retention/edema.

Hepatic

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

Nervous system

Very common (10% or more): Headache (up to 15%)

Common (1% to 10%): Syncope

Respiratory

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

Hematologic

Very common (10% or more): Hemoglobin decreased (up to 57%)

Common (1% to 10%): Anemia, hematocrit decreased

Postmarketing reports: Thrombocytopenia, transfusion, neutropenia, leukopenia

Cardiovascular

Common (1% to 10%): Flushing, hypotension, palpitation, orthostatic hypotension, unstable angina, hot flush

Gastrointestinal

Common (1% to 10%): Gastroesophageal reflux disease, diarrhea

Dermatologic

Common (1% to 10%): Pruritus, erythema

Postmarketing reports: Angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), rash, dermatitis

Genitourinary

Very common (10% or more): Sperm count decreased (25%)

Musculoskeletal

Common (1% to 10%): Arthralgia, joint swelling

Ocular

Common (1% to 10%): Vision blurred

Other

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

Immunologic

Common (1% to 10%): Hypersensitivity reaction

Postmarketing reports: Anaphylaxis

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Tracleer