Bosentan Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 11, 2025.

Applies to bosentan: oral tablet, oral tablet for suspension.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests are needed to check your liver function before you start using bosentan and each month after that. Urine tests may also be needed to check for unwanted effects.

Using this medicine while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using this medicine (even if the medicine is temporarily stopped), and for at least one month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had tubal ligation, she does not need to use a second form of birth control. If you think you have become pregnant while using this medicine, tell your doctor right away.

You must have a negative pregnancy test before you will be allowed to take this medicine. You will also be required to have a pregnancy test every month during your treatment and for 1 month after your last dose. If you miss a period while you are using this medicine, tell your doctor right away.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Bosentan may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

This medicine may cause fluid retention (edema) in some patients. Check with your doctor right away if you are gaining weight rapidly, have swelling in your hands, ankles, feet, or all over the body, or if you have trouble with breathing while you are using this medicine.

Pulmonary edema may occur while using this medicine. Check with your doctor right away if you have chest pain, difficult, fast, noisy breathing, sometimes with wheezing, blue lips and fingernails, pale skin, increased sweating. coughing that sometimes produces a pink frothy sputum, or shortness of breath.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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

Symptoms of overdose

• increased heart rate

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:

For healthcare professionals

Applies to bosentan: oral tablet, oral tablet dispersible.

General adverse events

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]

See also:

Further information

Bosentan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer