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Bosentan Side Effects

In Summary

Commonly reported side effects of bosentan 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

In addition to its needed effects, some unwanted effects may be caused by bosentan. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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 and vomiting
  • stomach pain
  • sudden sweating
  • unusual tiredness or weakness
  • 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, sometimes with wheezing
  • fainting
  • fast heartbeat
  • fatigue on exertion
  • fever
  • headache
  • hives
  • hoarseness
  • increased sweating
  • irritation
  • itching
  • 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
  • rash
  • 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
  • troubled breathing or swallowing
  • troubled breathing with exertion
  • unpleasant breath odor
  • unusual bleeding or bruising
  • vomiting of blood
  • weight gain
  • wheezing

If any of the following symptoms of overdose occur while taking bosentan, get emergency help immediately:

Symptoms of overdose:
  • Increased heart rate

Minor Side Effects

Some of the side effects that can occur with bosentan may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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:
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain

For Healthcare Professionals

Applies to bosentan: oral tablet

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

Not all side effects for bosentan may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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