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Tracleer Side Effects

Generic Name: bosentan

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)

Because of the risks of hepatotoxicity and embryo-fetal toxicity, bosentan may be prescribed only through the Bosentan REMS Program. 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.

Side effects requiring immediate medical attention

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

Side effects not requiring immediate medical attention

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

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.[Ref]

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[Ref]

Nervous system

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

Common (1% to 10%): Syncope[Ref]

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[Ref]

Hematologic

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

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

Postmarketing reports: Thrombocytopenia, transfusion, neutropenia, leukopenia[Ref]

Cardiovascular

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

Gastrointestinal

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

Dermatologic

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

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

Genitourinary

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

Musculoskeletal

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

Ocular

Common (1% to 10%): Vision blurred[Ref]

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[Ref]

Immunologic

Common (1% to 10%): Hypersensitivity reaction

Postmarketing reports: Anaphylaxis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Tracleer (bosentan)." Acetelion Pharmaceuticals US, Inc, South San Francisco, CA.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.