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Tracleer (Bosentan) - Pulmonary Arterial Hypertension - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Pulmonary Arterial Hypertension (398)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tracleer (Bosentan) where reactions include pulmonary arterial hypertension. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 398   Next >>

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 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 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 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 80 year old female

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

Patient: 80 year old female

Reactions: Death, Pulmonary Arterial Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 5 year old female

Reported by a physician from United States on 2012-08-22

Patient: 5 year old female

Reactions: Vomiting, Pulmonary Arterial Hypertension, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Remodulin

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-06-30

Other drugs received by patient: Sildenafil



Possible Tracleer side effects in 74 year old female

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

Patient: 74 year old female

Reactions: Cardioversion, Dyspnoea, Pulmonary Arterial Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin



Possible Tracleer side effects in 40 year old male

Reported by a health professional (non-physician/pharmacist) from Israel on 2012-08-20

Patient: 40 year old male

Reactions: Condition Aggravated, Pulmonary Arterial Hypertension

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio



Possible Tracleer side effects in 38 year old female

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

Patient: 38 year old female

Reactions: Fluid Overload, Dyspnoea, Pulmonary Arterial Hypertension, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Revatio



Possible Tracleer side effects in 68 year old female

Reported by a physician from United States on 2012-08-16

Patient: 68 year old female

Reactions: Weight Increased, Death, Fatigue, Pulmonary Arterial Hypertension, Oedema, Gait Disturbance, Asthenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Tyvaso; Lasix



Possible Tracleer side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: 37 year old female

Reactions: Fluid Overload, Chest Discomfort, Dyspnoea, Pulmonary Arterial Hypertension, Oedema, Blood Creatinine Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-04-24

Tracleer
    Administration route: Oral

Other drugs received by patient: Revatio; Coumadin; Tyvaso; Diuretics



Possible Tracleer side effects in 48 year old female

Reported by a pharmacist from United States on 2012-08-14

Patient: 48 year old female

Reactions: Dyspnoea, Gastrointestinal Haemorrhage, International Normalised Ratio Increased, Myocardial Ischaemia, Pulmonary Arterial Hypertension, Hepatic Failure, Cardiac Failure, Hepatic Congestion, Gastrointestinal Disorder, Oedema, Myocardial Infarction, Acute Respiratory Failure, Melaena

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin



Possible Tracleer side effects in 70 year old female

Reported by a pharmacist from United States on 2012-08-14

Patient: 70 year old female

Reactions: Pneumonia, Respiratory Disorder, Lung Neoplasm Malignant, Pulmonary Arterial Hypertension, Tracheostomy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 46 year old female

Reported by a physician from Brazil on 2012-08-13

Patient: 46 year old female, weighing 58.0 kg (127.6 pounds)

Reactions: Atrial Tachycardia, Arrhythmia Supraventricular, Nausea, Ischaemic Stroke, Condition Aggravated, Pulmonary Arterial Hypertension, Drug Interaction, PO2 Decreased, Pulmonary Arterial Pressure Increased, Malaise, Ventricular Tachycardia, Gastroenteritis, Dizziness, Deep Vein Thrombosis, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient possibly interacting with the suspect drug:
Sildenafil
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-09-01

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2008-06-26
    End date: 2008-07-26

Other drugs received by patient: Plavix; Aldactone



Possible Tracleer side effects in 73 year old male

Reported by a physician from United States on 2012-08-10

Patient: 73 year old male

Reactions: Musculoskeletal Pain, Chest Pain, Pulmonary Arterial Hypertension

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil



Possible Tracleer side effects in 59 year old male

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

Patient: 59 year old male

Reactions: Heart Rate Increased, Pulmonary Arterial Hypertension, Dizziness

Adverse event resulted in: death

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil; Aspirin; Tyvaso



Possible Tracleer side effects in 37 year old female

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

Patient: 37 year old female

Reactions: Right Ventricular Failure, Caesarean Section, Premature Baby, Pulmonary Arterial Hypertension, Headache, Pregnancy, Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2006-03-08
    End date: 2009-01-01

Tracleer
    Administration route: Oral
    Start date: 2009-06-23

Other drugs received by patient: Sildenafil; Enoxaparin; Remodulin; Spironolactone; Warfarin Sodium; Digoxin



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 80 year old female

Reported by a physician from Taiwan, Province of China on 2012-07-31

Patient: 80 year old female

Reactions: Pulmonary Arterial Hypertension, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Remodulin

Remodulin

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral

Ventavis
    Indication: Pulmonary Arterial Hypertension

Viagra



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: Pneumonia, Dyspnoea, Hepatic Failure, Pulmonary Arterial Hypertension, Organ Failure, Gastrointestinal Infection, Fatigue, Pulmonary Oedema

Adverse event resulted in: hospitalization

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 2012-07-25

Patient:

Reactions: Pulmonary Arterial Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 5.2 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-01-11
    End date: 2012-04-22

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-09-21

Other drugs received by patient: Plavix; Coumadin; Aspirin



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-25

Patient:

Reactions: Pulmonary Arterial Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 5.2 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-01-11
    End date: 2012-04-22

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-09-21

Other drugs received by patient: Coumadin; Aspirin; Plavix



Possible Tracleer side effects in

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

Patient:

Reactions: Pneumonia, Lung Neoplasm Malignant, Tracheostomy, Pulmonary Arterial Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-24

Patient:

Reactions: Renal Failure, Malaise, Swelling, Oedema Peripheral, Pulmonary Arterial Hypertension, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 26 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-02-29

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Coumadin; Combivir; Adcirca; Lexiva



Possible Tracleer side effects in

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

Patient:

Reactions: Disease Complication, Pulmonary Arterial Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil



Possible Tracleer side effects in 81 year old male

Reported by a physician from Austria on 2012-07-23

Patient: 81 year old male

Reactions: Cardiac Failure, Pulmonary Arterial Hypertension

Adverse event resulted in: death

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in

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

Patient:

Reactions: Fluid Overload, Dyspnoea, Renal Disorder, Urinary Tract Infection, Pulmonary Arterial Hypertension, Pyrexia, Death, Renal Failure, Dialysis, Sepsis, Abnormal Loss of Weight, Cardiac Failure Congestive

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Start date: 2010-02-24
    End date: 2010-06-15

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2010-01-23
    End date: 2010-02-23

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-07-21
    End date: 2012-07-07

Tracleer
    Dosage: unk
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-07-01

Other drugs received by patient: Tyvaso; Coumadin; Plavix



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 female

Reported by a physician from Brazil on 2012-07-20

Patient: female, weighing 58.0 kg (127.6 pounds)

Reactions: Arrhythmia Supraventricular, Atrial Tachycardia, Ischaemic Stroke, Pulmonary Arterial Hypertension, Condition Aggravated, Drug Interaction, Pulmonary Arterial Pressure Increased, PO2 Decreased, Ventricular Tachycardia, Gastroenteritis, Deep Vein Thrombosis, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient possibly interacting with the suspect drug:
Sildenafil
    Indication: Pulmonary Arterial Hypertension

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2008-06-26
    End date: 2008-07-26

Other drugs received by patient: Aldactone; Plavix



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