DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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 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



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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014