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
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
- 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
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- blue lips and fingernails
- chest pain
- 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
- fast heartbeat
- fatigue on exertion
- increased sweating
- 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
- troubled breathing or swallowing
- troubled breathing with exertion
- 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
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
- Acid or sour stomach
- stomach discomfort, upset, or pain
For Healthcare Professionals
Applies to bosentan: oral tablet
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 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 side effects including flushing (9%), lower limb edema (8%), edema (4%), and fatigue (4%) have been reported.
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 side effects including nasopharyngitis (11%) have been reported.
Gastrointestinal side effects including diarrhea (9%) and dyspepsia (4%) have been reported.
Hypersensitivity reactions including rash and angioneurotic edema have been reported in postmarketing studies.
Dermatologic side effects have included pruritus (4%).
Nervous system side effects have included headache (14% to 22%) and dizziness (8%).
Genitourinary side effects including reduced sperm counts have been reported.
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