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Tracleer (Bosentan) - Syncope - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Syncope (249)

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

 Reports 1 - 30 of 249   Next >>

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 70 year old female

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

Patient: 70 year old female

Reactions: Thrombosis, Syncope, Oedema, Musculoskeletal Chest Pain, Fall, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Adcirca; Plavix



Possible Tracleer side effects in 61 year old male

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

Patient: 61 year old male

Reactions: Syncope, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil; 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 35 year old female

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

Patient: 35 year old female

Reactions: Drug Dose Omission, Syncope, Cardiac Pacemaker Replacement

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 61 year old male

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

Patient: 61 year old male

Reactions: Syncope, Tremor

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil; Coumadin



Possible Tracleer side effects in 38 year old female

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

Patient: 38 year old female

Reactions: Headache, Fatigue, Oedema Peripheral, Pulmonary Congestion, Chest Pain, Pulmonary Oedema, Dizziness, Cough, Decreased Appetite, Dyspnoea, Vomiting, Nausea, Hypotension, Syncope, Diarrhoea, Hepatic Congestion, Asthenia

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-02-03

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-12-17

Other drugs received by patient: Revatio; Digoxin



Possible Tracleer side effects in 58 year old female

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

Patient: 58 year old female

Reactions: Syncope, Ammonia Increased, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio



Possible Tracleer side effects in 85 year old male

Reported by a pharmacist from Germany on 2012-08-03

Patient: 85 year old male

Reactions: Speech Disorder, Syncope, Convulsion

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Ramipril; Prednisolone; Aldactone; Pravastatin; Bisoprolol Fumarate; Nitrendipin; Torsemide



Possible Tracleer side effects in 77 year old female

Reported by a physician from United States on 2012-08-03

Patient: 77 year old female

Reactions: Syncope, Concussion, Contusion, Fall, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Ticlid; Calcium Channel Blockers; Adcirca; Oxygen; Plavix; Amiodarone HCL



Possible Tracleer side effects in 57 year old female

Reported by a pharmacist from United States on 2012-08-03

Patient: 57 year old female

Reactions: Syncope, Head Injury, Dizziness, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Adcirca



Possible Tracleer side effects in 65 year old male

Reported by a pharmacist from United States on 2012-08-02

Patient: 65 year old male

Reactions: Syncope, Pain, Device Related Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Aspirin



Possible Tracleer side effects in 35 year old female

Reported by a pharmacist from United States on 2012-08-02

Patient: 35 year old female

Reactions: Drug Dose Omission, Syncope, Cardiac Pacemaker Replacement

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 72 year old female

Reported by a pharmacist from United States on 2012-07-31

Patient: 72 year old female

Reactions: Syncope, Cerebrovascular Accident, Fall

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Coumadin; Sildenafil



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-26

Patient:

Reactions: Syncope, Dizziness, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Tyvaso



Possible Tracleer side effects in

Reported by a pharmacist from United States on 2012-07-26

Patient:

Reactions: Night Sweats, Dyspnoea, Oxygen Saturation Abnormal, Fatigue, Malaise, Dyspnoea Exertional, Syncope, Pulmonary Congestion, Oedema Peripheral, Lethargy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Remodulin



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 2012-07-23

Patient:

Reactions: Syncope, Pneumonia, Dizziness Exertional, Dialysis, Dysphonia, Laceration, Sinus Congestion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Aspirin



Possible Tracleer side effects in

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

Patient:

Reactions: Contusion, Syncope, Concussion, Fall, Ligament Sprain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Oxygen; Ticlid; Adcirca; Calcium Channel Blockers; Amiodarone HCL; 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

Reported by a physician from United States on 2012-07-19

Patient:

Reactions: Syncope, Convulsion

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Adcirca



Possible Tracleer side effects in

Reported by a physician from United States on 2012-07-18

Patient:

Reactions: Syncope, Osteoporosis, Chest Pain, Atrial Fibrillation, Dizziness, Bradycardia, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5mg bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-03-26

Viagra

Other drugs received by patient: Gabapentin; Propylene Glycol; Coenzyme Q10; Digoxin; Lisinopril; Metformin Hydrochloride; Nitroglycerin; Ascorbic Acid; Artificial Tears; Colecalciferol; Coumadin; Metoprolol Succinate; Hydrochlorothiazide; Calcium Channel Blockers; Trazodone Hydrochloride; Albuterol; Novolin N; Aspirin; Pantoprazole; Duloxetime Hydrochloride; Simvastatin; Lorazepam; Clotrimazole; Epipen



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

Patient:

Reactions: Cardiac Pacemaker Battery Replacement, Syncope

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in

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

Patient:

Reactions: Syncope, Cardio-Respiratory Arrest, Cyanosis, Nausea, Pulmonary Arterial Hypertension, Disease Progression

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Cardizem; Epoprostenol Sodium



Possible Tracleer side effects in

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

Patient:

Reactions: Pruritus, Fall, Death, Malaise, Fatigue, Balance Disorder, Oedema Peripheral, Dizziness, Oedema, Cardiac Failure Congestive, Decreased Appetite, Fluid Retention, Localised Infection, Dyspnoea, Neurogenic Bladder, Vomiting, Nausea, Laceration, Musculoskeletal Chest Pain, Rash Macular, Syncope, Urine Colour Abnormal, Blood Pressure Decreased, Asthenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-01-01

Tracleer
    Dosage: unk
    Administration route: Oral
    Start date: 2009-05-01
    End date: 2011-03-01

Other drugs received by patient: Oxygen; Plavix; Aspirin; Sildenafil



Possible Tracleer side effects in

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

Patient:

Reactions: Syncope, Cerebrovascular Accident, Fall

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil; Coumadin



Possible Tracleer side effects in

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

Patient:

Reactions: Drug Dose Omission, Rectal Haemorrhage, Headache, Disorientation, Vaginal Haemorrhage, Fatigue, Syncope, Renal Failure, Hyperglycaemic Hyperosmolar Nonketotic Syndrome, Dehydration, Disturbance in Attention, Diabetes Mellitus Inadequate Control, Blood Glucose Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Oxygen; Revatio; Pancrelipase; Coumadin



Possible Tracleer side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06

Patient:

Reactions: Drug Level Changed, Loss of Consciousness, Burning Sensation, Pruritus Generalised, Neuropathy Peripheral, Syncope, Cardiac Pacemaker Insertion, Oedema, Heart Rate Irregular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Digoxin; Coumadin; Folic Acid; Lasix; Spironolactone



Possible Tracleer side effects in

Reported by a pharmacist from United States on 2012-07-06

Patient:

Reactions: Syncope, Convulsion

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Adcirca



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