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Last reviewed on RxList: 5/10/2019
Tracleer Side Effects Center

Last reviewed on RxList 5/10/2019

Tracleer (bosentan) is an endothelin receptor antagonist, which works to help decrease blood pressure in the lungs, used to treat pulmonary arterial hypertension (PAH). Tracleer improves your ability to exercise and prevents your condition from getting worse. Common side effects of Tracleer include:

  • dizziness,
  • flushing,
  • upset stomach,
  • fatigue,
  • tiredness,
  • headache,
  • swelling of the feet/ankles/legs, or
  • itching.

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.


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Tracleer Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

  • swelling in your legs or ankles, with or without weight gain;
  • a light-headed feeling, like you might pass out;
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;
  • liver problems--nausea, vomiting, fever, upper stomach pain, tiredness, dark urine, jaundice (yellowing of the skin or eyes); or
  • new lung problems--anxiety, sweating, pale skin, severe shortness of breath, wheezing, gasping for breath, cough with foamy mucus, chest pain, fast or uneven heart rate.

Common side effects may include:

  • headache, joint pain;
  • low blood pressure, fainting;
  • flushing (warmth, redness, or tingly feeling);
  • irregular heartbeats; or
  • cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

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.

Read the entire detailed patient monograph for Tracleer (Bosentan)


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Tracleer Professional Information


The following important adverse reactions are described elsewhere in the labeling:

Clinical Trials 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 openlabel) in 870 adult patients with PAH 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 PAH 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 adult patients with PAH 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 PAH at doses of 125 or 250 mg twice daily are shown in Table 3:

Table 3. 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

Adverse Event   Tracleer
n = 258
n = 172
No. % No. %
Respiratory Tract Infection** 56 22% 30 17%
Headache 39 15% 25 14%
Edema 28 11% 16 9%
Chest Pain 13 5% 8 5%
Syncope 12 5% 7 4%
Flushing 10 4% 5 3%
Hypotension 10 4% 3 2%
Sinusitis 9 4% 4 2%
Arthralgia 9 4% 3 2%
Serum Aminotransferases, abnormal 9 4% 3 2%
Palpitations 9 4% 3 2%
Anemia 8 3% - -
*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.
** Respiratory Tract Infection combines the terms "Nasopharyngitis", "Upper Respiratory Tract Infection" and "Respiratory Tract Infection". Combined data from Study 351, BREATHE-1 and EARLY

Tracleer was evaluated for safety in 119 pediatric patients in uncontrolled studies. The safety profile was similar to that observed in adult patients with PAH.

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. Twentyfive 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 adult 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 Tracleertreated 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.

In a pooled analysis of pediatric patients (N=100) with PAH treated with Tracleer, a decrease in hemoglobin levels to < 10 g/dL from baseline was reported in 11% of patients. There was no decrease to < 8 g/dL.

Postmarketing Experience

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 BOX WARNING]
Liver failure [see BOX WARNING]
Hypersensitivity, DRESS, and anaphylaxis [see CONTRAINDICATIONS]
Anemia requiring transfusion
Neutropenia and leukopenia
Nasal congestion

Read the entire FDA prescribing information for Tracleer (Bosentan)

Related Resources for Tracleer

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Read the Tracleer User Reviews »

© Tracleer Patient Information is supplied by Cerner Multum, Inc. and Tracleer Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.


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