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.

Some side effects of Tracleer may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to bosentan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking bosentan (the active ingredient contained in Tracleer) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• nausea, stomach pain, loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects of bosentan may include:

• headache;

• flushing;

• swelling of the feet, ankles, or legs;

• dizziness;

• upset stomach;

• fatigue; or

• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to bosentan: oral tablet

Hepatic

Hepatic side effects including elevations in aminotransferases (ALT/AST) have been reported. Bosentan has resulted in at least 3-fold upper limit of normal elevation of liver aminotransferases (ALT/AST) in approximately 11% of treated patients accompanied by elevated bilirubin in small number of cases. Serum aminotransferases must be measured prior to initiating therapy and monthly thereafter. Due to the potential for serious liver injury, bosentan (the active ingredient contained in Tracleer) should be avoided in patients with moderate or severe liver impairment. In addition, it should generally be avoided in patients with elevated aminotransferases (more than 3 times the upper limit of normal) since monitoring liver injury in such patients may be more difficult.

Rare cases of liver failure have been reported during postmarketing.

Elevations of AST and/or ALT associated with bosentan are dose-dependent and can occur both early and late in treatment. The elevations generally progress slowly and are typically asymptomatic. Elevations are usually reversible after treatment, interruption or cessation. In addition, the aminotransferase observations may reverse spontaneously while continuing treatment with bosentan.

If aminotransferase elevations are accompanied by clinical symptoms of liver injury (e.g., nausea, vomiting, fever, abdominal pain, jaundice, lethargy, fatigue) or increases in bilirubin are >= 2 times the upper limit of normal, treatment should be stopped.

Postmarketing studies have reported rare cases of unexplained hepatic cirrhosis after prolonged therapy (greater than 12 months) with bosentan in patients with multiple comorbidities and drug therapies. In at least one case, the initial presentation (after more than 20 months of treatment) included pronounced elevations in aminotransferases and bilirubin levels accompanied by nonspecific symptoms, all of which resolved slowly over time after discontinuation of bosentan. This reinforces the importance of strict adherence to the monthly monitoring schedule for the duration of treatment and the treatment algorithm, which includes stopping bosentan with a rise of aminotransferases accompanied by signs or symptoms of liver dysfunction. Elevations in aminotransferases require close attention.

Hematologic

Hematologic side effects including dose-related decreases in hematocrit and hemoglobin have been observed in patients treated with bosentan (the active ingredient contained in Tracleer) Hemoglobin levels should be monitored after 1 and 3 months of treatment and then every 3 months. If a marked decrease in hemoglobin concentration occurs, further examination should be undertaken to determine the cause and need for specific treatment. Thrombocytopenia has been reported in postmarketing studies.

General

General side effects including flushing (9%), lower limb edema (8%), edema (4%), and fatigue (4%) have been reported.

Cardiovascular

Cardiovascular side effects including hypotension (7%) and palpitations (5%) have been reported. At least one case of leukocytoclastic vasculitis has been reported. In addition, data from a placebo-controlled trial of patients with severe chronic heart failure treated with bosentan (the active ingredient contained in Tracleer) showed an increased incidence of hospitalization for CHF associated with weight gain and increased leg edema during the first 4 to 8 weeks of therapy. There have also been numerous postmarketing reports of fluid retention in patients with pulmonary hypertension occurring within weeks after starting bosentan. In addition, the possibility of associated pulmonary veno-occlusive disease should be considered if signs of pulmonary edema develop following bosentan administration. If this occurs, bosentan should be discontinued.

Respiratory

Respiratory side effects including nasopharyngitis (11%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (9%) and dyspepsia (4%) have been reported.

Hypersensitivity

Hypersensitivity reactions including rash and angioneurotic edema have been reported in postmarketing studies.

Dermatologic

Dermatologic side effects have included pruritus (4%).

Nervous system

Nervous system side effects have included headache (14% to 22%) and dizziness (8%).

Genitourinary

Genitourinary side effects including reduced sperm counts have been reported.

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