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Tracleer (Bosentan) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



Index of reports > Life Threatening Events (206)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tracleer (Bosentan) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 206   Next >>

Possible Tracleer side effects in 69 year old female

Reported by a pharmacist from United States on 2012-08-24

Patient: 69 year old female

Reactions: Malaise, Nausea, Urticaria, Dizziness, Transient Ischaemic Attack

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin



Possible Tracleer side effects in 74 year old male

Reported by a physician from United States on 2012-08-24

Patient: 74 year old male

Reactions: HIP Fracture, Dehydration

Adverse event resulted in: life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin



Possible Tracleer side effects in 58 year old male

Reported by a physician from United States on 2012-08-21

Patient: 58 year old male

Reactions: Pulmonary Artery Therapeutic Procedure, Pulmonary Artery Aneurysm, Arterial Rupture

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Tyvaso; Coumadin



Possible Tracleer side effects in 52 year old female

Reported by a pharmacist from United States on 2012-08-21

Patient: 52 year old female

Reactions: Back Pain, Pulmonary Hypertension, Respiratory Disorder, Dyspnoea, Cardiac Disorder, Fatigue, Lung Disorder, Joint Swelling, Chest Pain, Pleural Effusion, Heart Rate Irregular, Oxygen Saturation Decreased, Cardiac Failure Congestive

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Pradaxa; Adcirca; Aspirin



Possible Tracleer side effects in 70 year old male

Reported by a physician from United States on 2012-08-17

Patient: 70 year old male

Reactions: Lymphadenopathy, Increased Upper Airway Secretion, Dyspnoea, Lung Neoplasm, Pulmonary Fibrosis, Disease Progression, Pseudomonas Bronchitis, Acute Respiratory Failure

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Spironolactone; Aspirin



Possible Tracleer side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: 77 year old female

Reactions: Device Leakage, Pneumonia, Device Related Infection, Pyrexia, Thrombosis in Device

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Remodulin; Coumadin



Possible Tracleer side effects in 63 year old male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 63 year old male

Reactions: Contusion, Road Traffic Accident, Ventricular Tachycardia, Loss of Consciousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 42 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 42 year old male

Reactions: Pneumonia, Mental Disorder, Depression, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Tyvaso; Ventavis; Oxygen; Coumadin



Possible Tracleer side effects in 77 year old female

Reported by a physician from United States on 2012-08-09

Patient: 77 year old female

Reactions: Device Leakage, Device Related Infection, Thrombosis in Device

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Remodulin; Revatio; Coumadin



Possible Tracleer side effects in 81 year old female

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

Patient: 81 year old female

Reactions: Cellulitis, Dyspnoea, COR Pulmonale

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    End date: 2012-01-01

Tracleer
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Other drugs received by patient: Aspirin; Sildenafil



Possible Tracleer side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Aspirin



Possible Tracleer side effects in 87 year old female

Reported by a physician from Japan on 2012-08-06

Patient: 87 year old female, weighing 35.5 kg (78.1 pounds)

Reactions: Hepatic Function Abnormal, Renal Impairment

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Beraprost
    Dosage: 120 ug, 3x/day
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2008-06-02

Sildenafil Citrate
    Dosage: 60 mg, 3x/day
    Administration route: Oral
    Start date: 2008-06-10

Tracleer
    Dosage: 62.5 mg, 2x/day
    Administration route: Oral
    Start date: 2007-07-26

Other drugs received by patient: Torsemide; BUP-4; Gasmotin; Flolan; Norvasc; Lansoprazole; Flolan; Halcion; Aldactone; Amoban; Lasix



Possible Tracleer side effects in 79 year old female

Reported by a physician from United States on 2012-08-06

Patient: 79 year old female

Reactions: Renal Disorder, Haemorrhage, Nausea, Anaemia, International Normalised Ratio Increased, Mental Status Changes, Toxicity To Various Agents, Osteoarthritis, Malaise, Renal Failure, Neck Pain, Dehydration, Transfusion, Asthenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Coumadin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2004-06-05

Other drugs received by patient: Aldactone; Cozaar; Lovenox



Possible Tracleer side effects in 8 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: 8 year old male

Reactions: Pulmonary Hypertension, Lung Disorder, Dyspnoea, Withdrawal of Life Support

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil



Possible Tracleer side effects in 43 year old female

Reported by a physician from United States on 2012-07-30

Patient: 43 year old female

Reactions: Weight Decreased, Right Ventricular Failure, Dyspnoea, Nausea, Supraventricular Tachycardia, Condition Aggravated, Pulmonary Arterial Hypertension, Lactic Acidosis, Cardiogenic Shock, Hypokalaemia, Palpitations, Ischaemic Hepatitis, Decreased Appetite, Renal Failure Acute

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 18.0 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-21

Epoprostenol Sodium
    Dosage: 30 ng/kg, per min

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-06-11

Other drugs received by patient: Lasix; Spironolactone; Potassium Chloride; Zaroxolyn; Warfarin Sodium; Torsemide; Risperidone; Ultram; Hydrocodone; Reglan



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-27

Patient:

Reactions: Death, Pneumonia

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Diuretics



Possible Tracleer side effects in

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient:

Reactions: Renal Cell Carcinoma, Death, Appendicectomy, Nephrectomy

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Tyvaso



Possible Tracleer side effects in female

Reported by a physician from Ireland on 2012-07-24

Patient: female, weighing 60.0 kg (132.0 pounds)

Reactions: Scleroderma Renal Crisis, Surgery, Intestinal Obstruction, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Iloprost

Tracleer
    Dosage: 62.5 mg, unk
    Administration route: Oral
    Indication: Digital Ulcer
    Start date: 2009-01-01

Other drugs received by patient: Zofran; Oxycodone HCL; Motilium; Mirtazapine; Imodium; Actiq; Lansoprazole; Zopiclone



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-24

Patient:

Reactions: Platelet Transfusion, Liver Function Test Abnormal, Hepatic Failure, Nervousness, Cardiomegaly

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-01-04
    End date: 2012-06-14

Ventavis
    Dosage: 5 mcg, x6/day
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-01-05

Other drugs received by patient: Adcirca; Revatio; Coumadin



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-24

Patient:

Reactions: Diabetic Coma

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient:

Reactions: Vocal Cord Disorder, Endotracheal Intubation Complication, Paraesthesia, Limb Crushing Injury, Road Traffic Accident, Cardiac Failure, Dysphonia, Chest Pain, Medical Induction of Coma, Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Lovenox; Adcirca; Digoxin



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-23

Patient:

Reactions: Pulmonary Artery Therapeutic Procedure, Pulmonary Artery Aneurysm, Arterial Rupture

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Tyvaso



Possible Tracleer side effects in

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient:

Reactions: Weight Decreased, Right Ventricular Failure, Dyspnoea, Pulmonary Arterial Hypertension, General Physical Health Deterioration, Heart and Lung Transplant, Ascites, Disease Progression, Syncope, Chest Pain, Feeling Abnormal, Fluid Retention, Decreased Appetite

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 22 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-05-11

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-12-09
    End date: 2012-05-11

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2010-11-10
    End date: 2010-12-08

Other drugs received by patient: Bumex; Lasix; Enbrel; Cellcept; MG 5; Protonix; Plaquenil; Morphine Sulfate; Amoxicillin; Calcium Carbonate; Cymbalta; Oxycodone HCL; Duoneb; Zotran; Fentanyl



Possible Tracleer side effects in

Reported by a pharmacist from United States on 2012-07-20

Patient:

Reactions: Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Aspirin; Coumadin



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-17

Patient:

Reactions: Dyspnoea, Pneumonia, Pyrexia, Wound Infection Staphylococcal, Fall, Meniere's Disease, Cardiac Valve Disease, Sepsis, Staphylococcal Bacteraemia, Kidney Infection, Face Injury, Cardiac Failure Congestive

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin



Possible Tracleer side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-17

Patient:

Reactions: Weight Decreased, Right Ventricular Failure, Dyspnoea, General Physical Health Deterioration, Pulmonary Arterial Hypertension, Heart and Lung Transplant, Ascites, Disease Progression, Syncope, Chest Pain, Feeling Abnormal, Decreased Appetite, Fluid Retention

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 22 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-05-11

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2010-11-10
    End date: 2010-12-08

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-12-09
    End date: 2012-05-11

Other drugs received by patient: Amoxicillin; Cymbalta; Lasix; Zotran; MG 5; Cellcept; Fentanyl; Enbrel; Plaquenil; Protonix; Bumex; Calcium Carbonate; Duoneb; Morphine; Oxycodone HCL



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-16

Patient:

Reactions: Pneumonia, Mental Disorder, Depression, Suicidal Ideation

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Ventavis; Revatio; Tyvaso; Oxygen



Possible Tracleer side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient:

Reactions: Toxicity To Various Agents

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Methotrexate
    Dosage: 10 mg, q1week

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension



Possible Tracleer side effects in

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient:

Reactions: Platelet Transfusion, Liver Function Test Abnormal, Hepatic Failure, Cardiomegaly, Nervousness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-01-04
    End date: 2012-06-14

Ventavis
    Dosage: 5 mcg, x6/day
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-01-05

Other drugs received by patient: Adcirca; Revatio; Coumadin



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-09

Patient:

Reactions: Pulmonary Hypertension, Death, Dyspnoea, Lung Disorder

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil



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