This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tracleer (Bosentan) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (6743)
Death (2110)
Life Threatening Events (206)
Disability (74)
Reports by Reaction Type
Death (1295),
Dyspnoea (1043),
Pneumonia (429),
Pulmonary Arterial Hypertension (398),
Fall (321),
Fluid Retention (281),
Dizziness (265),
Oedema Peripheral (259),
Cardiac Failure Congestive (249),
Syncope (249),
Fatigue (242),
Chest Pain (231)
Below are a few examples of reports where side effects / adverse reactions may be related to Tracleer (Bosentan). For a complete list or a specific selection of reports, please use the links above.
Possible Tracleer side effects in 54 year old female
Reported by a physician from United States on 2012-08-27
Patient: 54 year old female
Reactions: Sepsis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epoprostenol Sodium
Dosage: 38.3 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2011-01-12
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in 75 year old female
Reported by a physician from United States on 2012-08-27
Patient: 75 year old female
Reactions: Right Ventricular Failure, Fall, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Treprostinil; Oxygen; Sildenafil; Warfarin Sodium
Possible Tracleer side effects in 25 year old female
Reported by a physician from United States on 2012-08-27
Patient: 25 year old female
Reactions: Appendicitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in 58 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 58 year old male
Reactions: Lung Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 83 year old female
Reported by a physician from United States on 2012-08-27
Patient: 83 year old female
Reactions: Arrhythmia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 86 year old female
Reported by a pharmacist from United States on 2012-08-27
Patient: 86 year old female
Reactions: Death, Malaise, Bladder Disorder, Bladder Cancer
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: unk
Administration route: Oral
Start date: 2012-01-01
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-01-05
End date: 2012-01-01
Possible Tracleer side effects in 53 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 53 year old female
Reactions: Renal Disorder, Hypotension, Generalised Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-05-05
End date: 2009-05-19
Tracleer
Dosage: unk
Administration route: Oral
Other drugs received by patient: Acetylsalicylic Acid SRT
Possible Tracleer side effects in 69 year old male
Reported by a pharmacist from United States on 2012-08-27
Patient: 69 year old male
Reactions: Disease Complication, Dyspnoea, Palpitations, Atrial Fibrillation, Cardiac Ablation, Cardiac Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 80 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 80 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Adcirca; Coumadin
Possible Tracleer side effects in 67 year old female
Reported by a physician from United States on 2012-08-27
Patient: 67 year old female
Reactions: Chest Tube Insertion, Pneumothorax, Blood Pressure Decreased, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 75 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 75 year old female
Reactions: Blood Potassium Abnormal, Haemorrhage, Pleural Effusion, Blood Potassium Increased, Oedema, Cardiac Failure Congestive, International Normalised Ratio Fluctuation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Tyvaso; Lasix; Coumadin; Sildenafil
Possible Tracleer side effects in 22 month old female
Reported by a physician from United States on 2012-08-27
Patient: 22 month old female
Reactions: Gastrointestinal Tube Insertion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil; Flolan
Possible Tracleer side effects in 62 year old female
Reported by a physician from France on 2012-08-27
Patient: 62 year old female
Reactions: Diarrhoea, Vertigo, Asthenia
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Start date: 2010-10-25
End date: 2010-12-13
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2010-09-25
End date: 2010-10-24
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Indication: Digital Ulcer
Start date: 2010-12-14
End date: 2011-02-15
Other drugs received by patient: Spironolactone; Motilium; Nexium
Possible Tracleer side effects in 35 year old female
Reported by a physician from United States on 2012-08-27
Patient: 35 year old female
Reactions: Pulmonary Arterial Hypertension, Fibrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in 77 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 77 year old female
Reactions: Dyspnoea, Pneumonia, Dementia Alzheimer's Type, Pulmonary Oedema, Pleural Effusion, Pulmonary Mass, Chronic Obstructive Pulmonary Disease, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Oxygen
Possible Tracleer side effects in 77 year old male
Reported by a physician from United States on 2012-08-27
Patient: 77 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil; Coumadin
Possible Tracleer side effects in 85 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 85 year old female
Reactions: Cerebrovascular Accident
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 47 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 47 year old female
Reactions: Subarachnoid Haemorrhage, Mental Disorder, Pulmonary Oedema
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Epoprostenol Sodium
Dosage: 24 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2012-06-06
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Possible Tracleer side effects in 68 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 68 year old female
Reactions: Dyspnoea, Cellulitis, Dizziness Exertional, Head Injury, Parkinson's Disease, Fall, Limb Injury, Chest Pain, Rotator Cuff Syndrome
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 47 year old male
Reactions: Paralysis, Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Lovenox; Sildenafil
Possible Tracleer side effects in 60 year old male
Reported by a pharmacist from United States on 2012-08-27
Patient: 60 year old male
Reactions: Nausea, Multiple Fractures
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Tyvaso
Possible Tracleer side effects in 13 year old male
Reported by a physician from United States on 2012-08-27
Patient: 13 year old male
Reactions: Weight Decreased, Death, Dysarthria, Hypoaesthesia Oral, Surgery, Hemiparesis, Convulsion
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil; Amicar; Tyvaso
Possible Tracleer side effects in 65 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 65 year old male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 53 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 53 year old male
Reactions: Medical Device Removal, Cardiac Failure Congestive
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 79 year old male
Reported by a pharmacist from United States on 2012-08-27
Patient: 79 year old male
Reactions: Atrioventricular Block Complete, Ventricular Tachycardia, Cardiac Arrest, Metastatic Carcinoma of THE Bladder
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Folic Acid; Adcirca; Terazosin Hydrochloride; Aspirin; Prednisone TAB; Citalopram Hydrobromide; Calcium +D; Finasteride; Multi-Vitamin
Possible Tracleer side effects in 55 year old female
Reported by a physician from United States on 2012-08-27
Patient: 55 year old female
Reactions: Dental Caries, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Aspirin
Possible Tracleer side effects in 73 year old male
Reported by a physician from United States on 2012-08-27
Patient: 73 year old male
Reactions: Cardiac Failure, Pulmonary Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in 52 year old female
Reported by a physician from United States on 2012-08-27
Patient: 52 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 61 year old female
Reported by a physician from United States on 2012-08-27
Patient: 61 year old female
Reactions: Transient Ischaemic Attack
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Effient; Ranexa; Adcirca
Possible Tracleer side effects in 70 year old female
Reported by a physician from United States on 2012-08-27
Patient: 70 year old female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Tyvaso; Aspirin; Sildenafil
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