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Tracleer (Bosentan) - Side Effect Reports to FDA

 
 



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 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



Possible Tracleer side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 60 year old female

Reactions: Cholecystectomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Aspirin; Plavix



Possible Tracleer side effects in 30 year old female

Reported by a physician from United States on 2012-08-27

Patient: 30 year old female

Reactions: Medical Device Complication, Syncope, Pulmonary Arterial Hypertension, Loss of Consciousness, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Oxygen; Digoxin; Viagra; Remodulin; 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: Dyspnoea, Respiratory Failure, Pulmonary Arterial Hypertension, Respiratory Arrest, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Pradaxa; Calcium Channel Blockers; Revatio; Adcirca; Coumadin



Possible Tracleer side effects in 53 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 53 year old male

Reactions: Myocardial Ischaemia, Transient Ischaemic Attack

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil



Possible Tracleer side effects in 55 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 55 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 65 year old female

Reactions: Weight Increased, Death, Fluid Retention

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 83 year old male

Reported by a physician from United States on 2012-08-27

Patient: 83 year old male

Reactions: Malaise, Dyspnoea, Oedema Peripheral, Asthenia, Chronic Obstructive Pulmonary Disease, Cardiac Disorder, Nervousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension



Possible Tracleer side effects in 75 year old female

Reported by a pharmacist from United States on 2012-08-27

Patient: 75 year old female

Reactions: Oral Surgery

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 75 year old male

Reported by a physician from United States on 2012-08-27

Patient: 75 year old male

Reactions: Cardiac Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin



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

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