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Tracleer Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Tracleer (bosentan) is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse. It is an endothelin receptor antagonist, which works to help decrease blood pressure in the lungs, slow the worsening of symptoms from the disease, and improve ability to exercise. Common side effects include dizziness, flushing, upset stomach, or tiredness.
The starting dose of Tracleer is 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily. Tracleer may interact with amiodarone, diltiazem, erythromycin, rifampin, tacrolimus, antifungal medications, blood thinners, or cholesterol-lowering medicines. Tell your doctor all medications you use. Tracleer must not be used during pregnancy. It may harm a fetus. If you become pregnant or think you may be pregnant, tell your doctor. Women of child-bearing age must have a negative pregnancy test before starting this medication and monthly while taking it; consult your doctor. It is recommended that men and women use 2 forms of birth control (e.g., condoms and diaphragm with spermicide) while taking this medication. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended.
Our Tracleer (bosentan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Tracleer in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 may include:
- swelling of the feet, ankles, or legs;
- upset stomach;
- fatigue; or
Read the entire detailed patient monograph for Tracleer (Bosentan)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Tracleer Overview - Patient Information: Side Effects
Dizziness, flushing, upset stomach, or tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, extreme tiredness, swelling of the ankles/feet, sudden/unexplained weight gain.
Tell your doctor immediately if any of these rare but very serious side effects occur: fainting, shortness of breath, coughing up blood.
In men, this medication can decrease sperm production, which may affect the ability to father a child. Talk to your doctor for more details.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Tracleer (Bosentan)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Tracleer FDA Prescribing Information: Side Effects
The following important adverse reactions are described elsewhere in the labeling:
- Hepatotoxicity [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
- Fluid retention [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Safety data on Tracleer were obtained from 13 clinical studies (9 placebo-controlled and 4 open-label) in 870 patients with pulmonary arterial hypertension and other diseases. Doses up to 8 times the currently recommended clinical dose (125 mg twice daily) were administered for a variety of durations. The exposure to Tracleer in these trials ranged from 1 day to 4.1 years (n=94 for 1 year; n=61 for 1.5 years and n=39 for more than 2 years). Exposure of pulmonary arterial hypertension patients (n=328) to Tracleer ranged from 1 day to 1.7 years (n=174 more than 6 months and n=28 more than 12 months).
Treatment discontinuations due to adverse events other than those related to pulmonary hypertension during the clinical trials in patients with pulmonary arterial hypertension were more frequent on Tracleer (6%; 15/258 patients) than on placebo (3%; 5/172 patients). In this database the only cause of discontinuations > 1% and occurring more often on Tracleer was abnormal liver function.
The adverse drug events that occurred in ≥ 3% of the Tracleer-treated patients and were more common on Tracleer in placebo-controlled trials in pulmonary arterial hypertension at doses of 125 or 250 mg twice daily are shown in Table 2:
Table 2: Adverse events* occurring in ≥ 3% of
patients treated with Tracleer 125-250 mg twice daily and more common on
Tracleer in placebo-controlled studies in pulmonary arterial hypertension
n = 258
n = 172
|Respiratory Tract Infection||56||22%||30||17%|
|Serum Aminotransferases, abnormal||9||4%||3||2%|
|*Note: only AEs with onset from start of treatment to 1 calendar day after end of treatment are included. All reported events (at least 3%) are included except those too general to be informative, and those not reasonably associated with the use of the drug because they were associated with the condition being treated or are very common in the treated population. Combined data from Study 351, BREATHE-1 and EARLY|
Decreased Sperm Counts
An open-label, single arm, multicenter, safety study evaluated the effect on testicular function of Tracleer 62.5 mg twice daily for 4 weeks, followed by 125 mg twice daily for 5 months. Twenty-five male patients with WHO functional class III and IV PAH and normal baseline sperm count were enrolled. Twenty-three completed the study and 2 discontinued due to adverse events not related to testicular function. There was a decline in sperm count of at least 50% in 25% of the patients after 3 or 6 months of treatment with Tracleer. Sperm count remained within the normal range in all 22 patients with data after 6 months and no changes in sperm morphology, sperm motility, or hormone levels were observed. One patient developed marked oligospermia at 3 months and the sperm count remained low with 2 follow-up measurements over the subsequent 6 weeks. Tracleer was discontinued and after 2 months the sperm count had returned to baseline levels. Based on these findings and preclinical data from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as Tracleer have an adverse effect on spermatogenesis.
Decreases in Hemoglobin and Hematocrit
Treatment with Tracleer can cause a dose-related decrease in hemoglobin and hematocrit. It is recommended that hemoglobin concentrations be checked after 1 and 3 months, and every 3 months thereafter. If a marked decrease in hemoglobin concentration occurs, further evaluation should be undertaken to determine the cause and need for specific treatment.
The overall mean decrease in hemoglobin concentration for Tracleer-treated patients was 0.9 g/dL (change to end of treatment). Most of this decrease of hemoglobin concentration was detected during the first few weeks of Tracleer treatment and hemoglobin levels stabilized by 4-12 weeks of Tracleer treatment. In placebo-controlled studies of all uses of Tracleer, marked decreases in hemoglobin ( > 15% decrease from baseline resulting in values < 11 g/dL) were observed in 6% of Tracleer-treated patients and 3% of placebo-treated patients. In patients with PAH treated with doses of 125 and 250 mg twice daily, marked decreases in hemoglobin occurred in 3% compared to 1% in placebo-treated patients.
A decrease in hemoglobin concentration by at least 1 g/dL was observed in 57% of Tracleer-treated patients as compared to 29% of placebo-treated patients. In 80% of those patients whose hemoglobin decreased by at least 1 g/dL, the decrease occurred during the first 6 weeks of Tracleer treatment.
During the course of treatment the hemoglobin concentration remained within normal limits in 68% of Tracleer-treated patients compared to 76% of placebo patients. The explanation for the change in hemoglobin is not known, but it does not appear to be hemorrhage or hemolysis.
There have been several postmarketing reports of angioedema associated with the use of Tracleer. The onset of the reported cases occurred within a range of 8 hours to 21 days after starting therapy. Some patients were treated with an antihistamine and their signs of angioedema resolved without discontinuing Tracleer.
The following additional adverse reactions have been reported during the postapproval use of Tracleer. Because these adverse reactions are reported from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Tracleer exposure:
Unexplained hepatic cirrhosis [see BOXED WARNING]
Liver failure [see BOXED WARNING]
Hypersensitivity [see CONTRAINDICATIONS]
Anemia requiring transfusion
Neutropenia and leukopenia
Read the entire FDA prescribing information for Tracleer (Bosentan)
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