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Bosentan Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 7, 2023.

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.

Serious side effects of Bosentan

Along with its needed effects, bosentan 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

Less common

Incidence not known

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

Symptoms of overdose

Other side effects of Bosentan

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

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. (2001) "Product Information. Tracleer (bosentan)." Actelion Pharmaceuticals US Inc

2. Cerner Multum, Inc. "UK Summary of Product Characteristics."

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

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.