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Index of reports
> Serious Reactions (1450)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tracleer (Bosentan) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 1450 Next >>
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 86 year old female
Reported by a pharmacist from United States on 2012-08-27
Patient: 86 year old female
Reactions: Death, Malaise, Bladder Disorder, Bladder Cancer
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: unk
Administration route: Oral
Start date: 2012-01-01
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-01-05
End date: 2012-01-01
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 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 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 58 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 58 year old male
Reactions: Lung Transplant
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
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 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 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 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
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 61 year old female
Reported by a physician from United States on 2012-08-24
Patient: 61 year old female
Reactions: Abdominal Pain, Vomiting, Retching, Nausea, Rectal Haemorrhage, Condition Aggravated, Mucous Stools, Abdominal Pain Upper, Haematochezia, Abdominal Discomfort, Diarrhoea, Gastrointestinal Disorder, Irritable Bowel Syndrome, Dizziness
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-07-15
Ventavis
Dosage: unk, x6/day
Indication: Pulmonary Arterial Hypertension
Start date: 2011-10-31
Ventavis
Dosage: 5 mcg, unk
Start date: 2011-11-07
End date: 2012-07-07
Other drugs received by patient: Aspirin; Vitamin D; Plavix; Celexa; Lovaza
Possible Tracleer side effects in 71 year old female
Reported by a pharmacist from United States on 2012-08-24
Patient: 71 year old female
Reactions: Cardioversion, Atrial Fibrillation
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2003-10-31
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2003-10-08
End date: 2003-10-30
Other drugs received by patient: Pradaxa
Possible Tracleer side effects in 22 year old male
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-24
Patient: 22 year old male
Reactions: Haemolytic Anaemia
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Furosemide; Warfarin Sodium
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 79 year old male
Reported by a physician from United States on 2012-08-24
Patient: 79 year old male
Reactions: Cerebrovascular Accident, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin
Possible Tracleer side effects in 45 year old female
Reported by a consumer/non-health professional from Brazil on 2012-08-24
Patient: 45 year old female
Reactions: Bedridden, Peripheral Coldness, Dyspnoea, Pain in Extremity, Pain, Headache, Erythema, Malaise, Dizziness, Extremity Necrosis
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 75 year old female
Reported by a pharmacist from United States on 2012-08-22
Patient: 75 year old female
Reactions: Fall, Ankle Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Sildenafil
Possible Tracleer side effects in 66 year old male
Reported by a pharmacist from United States on 2012-08-22
Patient: 66 year old male
Reactions: Renal Disorder, Pulmonary Embolism, Musculoskeletal Discomfort, Cyst, Amputation, Fall, Walking AID User, Liver Disorder, Transfusion, Skeletal Injury
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
Other drugs received by patient: Sildenafil; Coumadin
Possible Tracleer side effects in 63 year old female
Reported by a physician from United States on 2012-08-22
Patient: 63 year old female
Reactions: Productive Cough, Malaise, Dyspnoea, Systemic Lupus Erythematosus, Insomnia, Wheezing, Lung Infection, Multiple Sclerosis, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 69 year old male
Reported by a physician from Hungary on 2012-08-22
Patient: 69 year old male
Reactions: Metastases To Liver, Pancreatic Carcinoma
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-06-26
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2012-05-29
End date: 2012-06-25
Other drugs received by patient: Revatio
Possible Tracleer side effects in 56 year old female
Reported by a pharmacist from United States on 2012-08-21
Patient: 56 year old female
Reactions: Lung Transplant
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 51 year old male
Reported by a pharmacist from United States on 2012-08-21
Patient: 51 year old male
Reactions: Ankle Operation, Lower Limb Fracture, Lumbar Vertebral Fracture, Ankle Fracture, Fall
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in 40 year old male
Reported by a physician from United States on 2012-08-21
Patient: 40 year old male
Reactions: Sepsis
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin; Sildenafil
Possible Tracleer side effects in 30 year old female
Reported by a physician from United States on 2012-08-21
Patient: 30 year old female
Reactions: Abortion Spontaneous, Pregnancy
Drug(s) suspected as cause:
Tracleer
Dosage: unk
Administration route: Oral
Start date: 2012-08-02
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-03-01
End date: 2012-05-31
Other drugs received by patient: Sildenafil
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 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 47 year old male
Reactions: Thrombosis, Pain in Extremity
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Coumadin
Possible Tracleer side effects in 46 year old male
Reported by a pharmacist from United States on 2012-08-20
Patient: 46 year old male
Reactions: Syncope, Dialysis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Plavix
Possible Tracleer side effects in 4 year old male
Reported by a physician from United States on 2012-08-20
Patient: 4 year old male
Reactions: Convulsion
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Adcirca; Remodulin
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