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 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 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 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 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 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 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 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 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 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 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
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
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