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Index of reports
> Cases with Respiratory Failure ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tracleer (Bosentan) where reactions include respiratory failure. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of Next >>
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 31 year old female
Reported by a physician from United States on 2012-08-24
Patient: 31 year old female
Reactions: Coagulopathy, Disseminated Intravascular Coagulation, Pyrexia, Pulmonary Oedema, Endocarditis, Hypoxia, Epistaxis, Right Ventricular Failure, Mechanical Ventilation, Metabolic Acidosis, Pneumonia, Hypotension, Pulmonary Arterial Wedge Pressure Increased, Myopathy, Bacteraemia, Subarachnoid Haemorrhage, Haemorrhage, Pulmonary Arterial Hypertension, Adrenal Insufficiency, Abdominal Distension, Ischaemic Hepatitis, Thrombocytopenia, Fluid Overload, Device Related Sepsis, Dyspnoea, Atrial Flutter, Condition Aggravated, Rash, Subdural Haemorrhage, Cardiogenic Shock, Blood Glucose Decreased, Renal Failure, Respiratory Failure, Respiratory Acidosis, Ventricular Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Epoprostenol Sodium
Dosage: 30 ng/kg, per min
Start date: 2010-10-19
End date: 2012-01-01
Epoprostenol Sodium
Dosage: 33 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2012-01-01
End date: 2012-06-17
Nafcillin
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2008-04-08
Other drugs received by patient: Remeron; Digoxin; Ferrous Sulfate TAB; Revatio; Zantac; Potassium Chloride; Hibiclens; Coumadin; Spironolactone; Celexa; Zofran; Furosemide; Oxycodone HCL; Oxygen
Possible Tracleer side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 73 year old female
Reactions: Death, Respiratory Failure, Mental Status Changes
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Aspirin
Possible Tracleer side effects in 79 year old female
Reported by a pharmacist from United States on 2012-08-16
Patient: 79 year old female
Reactions: Pneumonia, Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin; Sildenafil
Possible Tracleer side effects in 30 year old male
Reported by a physician from Ireland on 2012-08-10
Patient: 30 year old male
Reactions: Cystic Fibrosis, Renal Failure, Respiratory Failure, Pain, Raynaud's Phenomenon
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Raynaud's Phenomenon
Start date: 2011-03-01
End date: 2011-09-17
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2011-02-01
End date: 2011-03-01
Possible Tracleer side effects in 75 year old female
Reported by a pharmacist from United States on 2012-08-10
Patient: 75 year old female
Reactions: Dyspnoea, Respiratory Failure, Nausea, Chronic Obstructive Pulmonary Disease, Faeces Discoloured, Oxygen Saturation Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Adcirca
Possible Tracleer side effects in 67 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03
Patient: 67 year old female
Reactions: Respiratory Failure, Respiratory Arrest, Pulmonary Arterial Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin; Adcirca; Calcium Channel Blockers; Revatio
Possible Tracleer side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: 65 year old female
Reactions: Pelvic Fracture, Respiratory Failure, Pain in Extremity, Decubitus Ulcer, Sepsis, Fall, Cerebrovascular Accident
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in female
Reported by a pharmacist from Germany on 2012-07-24
Patient: female, weighing 58.0 kg (127.6 pounds)
Reactions: Pulmonary Hypertension, Dyspnoea, General Physical Health Deterioration, Fall, Periorbital Haematoma, Syncope, Cyanosis, Respiratory Failure, Aspiration Pleural Cavity, Oedema Peripheral, Pleural Effusion, Heart Rate Irregular, Apnoea
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Pulmonary Hypertension
End date: 2012-05-31
Tracleer
Dosage: unk , unk
Administration route: Oral
Start date: 2008-05-01
Other drugs received by patient: Xipamide; Oxygen; Revatio; Spiriva; Torsemide; Fluticasone Propionate / Salmeterol
Possible Tracleer side effects in
Reported by a physician from United States on 2012-07-19
Patient:
Reactions: Respiratory Failure, Cardiac Pacemaker Insertion, Atrial Fibrillation, Cardiac Ablation, Tracheostomy, Endotracheal Intubation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-07-18
Patient:
Reactions: Gastrointestinal Haemorrhage, Respiratory Failure, Sepsis, Hypotension, Packed RED Blood Cell Transfusion
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Ventavis
Dosage: unk
Indication: Pulmonary Arterial Hypertension
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in
Reported by a physician from United States on 2012-07-16
Patient:
Reactions: Nausea, Respiratory Failure, Chronic Obstructive Pulmonary Disease, Oxygen Saturation Decreased, Faeces Discoloured
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Adcirca
Possible Tracleer side effects in
Reported by a consumer/non-health professional from United States on 2012-07-12
Patient:
Reactions: Pulmonary Hypertension, Haemorrhage, Coagulopathy, Pyrexia, Pulmonary Oedema, Hypoxia, Adrenal Insufficiency, Abdominal Distension, Endocarditis, Ischaemic Hepatitis, Thrombocytopenia, Epistaxis, Fluid Overload, Device Related Sepsis, Right Ventricular Failure, Mechanical Ventilation, Dyspnoea, Pneumonia, Metabolic Acidosis, Atrial Flutter, Rash, Pulmonary Arterial Wedge Pressure Increased, Cardiogenic Shock, Subdural Haemorrhage, Myopathy, Blood Glucose Decreased, Renal Failure, Respiratory Acidosis, Respiratory Failure, Bacteraemia, Subarachnoid Haemorrhage, Ventricular Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Epoprostenol Sodium
Dosage: 33 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2012-01-01
End date: 2012-06-17
Epoprostenol Sodium
Dosage: 30 ng/kg, per min
Start date: 2010-10-19
End date: 2012-01-01
Nafcillin
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2008-04-08
Other drugs received by patient: Furosemide; Potassium Chloride; Oxycodone HCL; Celexa; Remeron; Coumadin; Digoxin; Hibiclens; Zofran; Zantac; Ferrous Sulfate TAB; Revatio; Spironolactone; Oxygen
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-07-09
Patient:
Reactions: Alcohol Withdrawal Syndrome, Respiratory Failure, Sepsis, Endotracheal Intubation, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Calcium Channel Blockers; Remodulin
Possible Tracleer side effects in
Reported by a physician from United States on 2012-07-06
Patient:
Reactions: Respiratory Failure, Respiratory Arrest, Pulmonary Arterial Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Adcirca; Coumadin; Revatio; Calcium Channel Blockers
Possible Tracleer side effects in 80 year old female
Reported by a consumer/non-health professional from Austria on 2012-07-06
Patient: 80 year old female
Reactions: Respiratory Failure, Pulmonary Fibrosis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-07-02
Patient:
Reactions: Pulmonary Hypertension, Haemorrhage, Coagulopathy, Pyrexia, Endocarditis, Hypoxia, Abdominal Distension, Pulmonary Oedema, Adrenal Insufficiency, Ischaemic Hepatitis, Thrombocytopenia, Epistaxis, Mechanical Ventilation, Fluid Overload, Right Ventricular Failure, Pneumonia, Metabolic Acidosis, Dyspnoea, Atrial Flutter, Pulmonary Arterial Wedge Pressure Increased, Rash, Cardiogenic Shock, Subdural Haemorrhage, Myopathy, Blood Glucose Decreased, Renal Failure, Subarachnoid Haemorrhage, Respiratory Failure, Respiratory Acidosis, Bacteraemia, Ventricular Fibrillation
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Epoprostenol Sodium
Dosage: 33 ng/kg, per min
Start date: 2012-01-01
End date: 2012-06-17
Epoprostenol Sodium
Dosage: 30 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2010-10-19
End date: 2012-01-01
Nafcillin
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2008-04-08
Other drugs received by patient: Remeron; Spironolactone; Hibiclens; Oxygen; Revatio; Oxycodone HCL; Zantac; Furosemide; Ferrous Sulfate TAB; Digoxin; Zofran; Celexa; Coumadin; Potassium Chloride
Possible Tracleer side effects in
Reported by a physician from United States on 2012-06-29
Patient:
Reactions: Alcohol Withdrawal Syndrome, Respiratory Failure, Sepsis, Endotracheal Intubation, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Calcium Channel Blockers; Remodulin
Possible Tracleer side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-26
Patient:
Reactions: Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-06-22
Patient:
Reactions: Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-06-21
Patient:
Reactions: Renal Failure, Respiratory Failure, Endotracheal Intubation, Treatment Noncompliance
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2011-03-29
Tracleer
Dosage: unk
Administration route: Oral
Start date: 2012-01-01
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-06-21
Patient:
Reactions: Respiratory Failure, Pulmonary Arterial Hypertension
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Calcium Channel Blockers; Viagra
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2012-06-14
Patient:
Reactions: Multi-Organ Failure, Respiratory Failure, Pulmonary Oedema, Bronchitis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in
Reported by a physician from United States on 2012-06-13
Patient:
Reactions: Respiratory Failure, Pneumothorax
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in
Reported by a physician from United States on 2012-06-13
Patient:
Reactions: Viral Test Positive, Respiratory Failure
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in
Reported by a physician from United States on 2012-06-13
Patient:
Reactions: Alcohol Withdrawal Syndrome, Respiratory Failure, Sepsis, Endotracheal Intubation, Loss of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Remodulin
Possible Tracleer side effects in female
Reported by a consumer/non-health professional from Australia on 2012-06-12
Patient: female, weighing 96.0 kg (211.2 pounds)
Reactions: Right Ventricular Failure, Dyspnoea, Pulmonary Arterial Hypertension, Exercise Test Abnormal, Disease Progression, Exercise Tolerance Decreased, Pulmonary Arterial Pressure Increased, Respiratory Failure, Respiratory Arrest, Cardiac Arrest
Adverse event resulted in: death, disablity
Drug(s) suspected as cause:
Sildenafil
Dosage: 20 mg, tid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2010-01-01
End date: 2012-01-01
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-09-19
End date: 2010-10-18
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Start date: 2010-10-19
End date: 2012-03-29
Ventavis
Dosage: 20 ?g, q4hrs
Indication: Pulmonary Arterial Hypertension
Start date: 2010-01-01
End date: 2012-03-01
Other drugs received by patient: Rabeprazole Sodium; Oxygen; Lasix; Spiractin
Possible Tracleer side effects in 19 year old female
Reported by a physician from Japan on 2012-06-12
Patient: 19 year old female, weighing 15.0 kg (33.0 pounds)
Reactions: Multi-Organ Failure, Hepatic Function Abnormal, Respiratory Failure, Gamma-Glutamyltransferase Increased, Bronchopneumonia, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Dosage: 31.25 mg, qd
Administration route: Oral
Start date: 2009-06-18
End date: 2009-07-23
Tracleer
Dosage: 31.25 mg, qd
Administration route: Oral
Start date: 2010-07-30
End date: 2010-08-13
Tracleer
Dosage: 93.75 mg, qd
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-11-25
End date: 2010-07-29
Tracleer
Dosage: 62.5 mg, qd
Administration route: Oral
Start date: 2009-07-24
End date: 2009-11-24
Other drugs received by patient: Erythromycin Ethylsuccinate; Carbocisteine; Ferric Sodium Citrate; Famotidine; Furosemide; Nifedipine; Enalapril Maleate; Fentanyl Citrate; Tocopheryl Nicotinate; Cefazolin Sodium; Spironolactone
Possible Tracleer side effects in 59 year old female
Reported by a physician from Turkey on 2012-06-08
Patient: 59 year old female
Reactions: Respiratory Failure, Pulmonary Arterial Hypertension, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 84 year old female
Reported by a physician from Turkey on 2012-06-08
Patient: 84 year old female
Reactions: Respiratory Failure, Pulmonary Arterial Hypertension, Disease Progression
Adverse event resulted in: death
Drug(s) suspected as cause:
Tracleer
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