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Tracleer (Bosentan) - Oedema Peripheral - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Oedema Peripheral (259)

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

 Reports 1 - 30 of 259   Next >>

Possible Tracleer side effects in 83 year old male

Reported by a physician from United States on 2012-08-27

Patient: 83 year old male

Reactions: Malaise, Dyspnoea, Oedema Peripheral, Asthenia, Chronic Obstructive Pulmonary Disease, Cardiac Disorder, Nervousness

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



Possible Tracleer side effects in 47 year old female

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

Patient: 47 year old female

Reactions: Weight Decreased, Migraine, Pneumonia, Adverse Drug Reaction, Hypotension, DRY Skin, Chronic Obstructive Pulmonary Disease, Oedema Peripheral, Visual Impairment, Heart Rate Increased, Dizziness, Myocardial Infarction, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-01-04
    End date: 2007-02-03

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Start date: 2007-02-04
    End date: 2007-02-13

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2007-02-17

Other drugs received by patient: Neurontin; Aspirin; Oxycontin; Valium; Prevacid; Lexapro; Epivir; Ziagen; Lasix; Eszopiclone; Albuterol; Viread



Possible Tracleer side effects in 52 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 52 year old female

Reactions: Dyspnoea, Nausea, Pain in Extremity, Headache, Pyrexia, Rash, Hyperhidrosis, Oedema Peripheral, Sinusitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Aspirin; Pradaxa; Revatio; Adcirca



Possible Tracleer side effects in 83 year old male

Reported by a pharmacist from United States on 2012-08-17

Patient: 83 year old male

Reactions: Malaise, Dyspnoea, Oedema Peripheral, Asthenia, Chronic Obstructive Pulmonary Disease, Nervousness, Cardiac Disorder

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



Possible Tracleer side effects in 82 year old female

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

Patient: 82 year old female

Reactions: Fatigue, Gout, Oedema Peripheral, Dizziness, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Sildenafil; Coumadin



Possible Tracleer side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 50 year old female

Reactions: Retinopathy, Eye Haemorrhage, Blood Potassium Decreased, Oedema Peripheral, Dizziness, Vision Blurred, Blood Glucose Increased, Muscle Spasms, Cardiac Failure Congestive

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Remodulin; Sildenafil



Possible Tracleer side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: 50 year old female, weighing 59.9 kg (131.7 pounds)

Reactions: Fluid Overload, Condition Aggravated, Ascites, Pericardial Effusion, Weight Increased, Dyspnoea Exertional, Oedema Peripheral, PH Body Fluid Abnormal, Cardiac Failure Congestive, Fluid Retention, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 44 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-03-05

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-05-01

Other drugs received by patient: Tadalafil; Coumadin



Possible Tracleer side effects in 47 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-13

Patient: 47 year old female

Reactions: Weight Decreased, Migraine, Pneumonia, Adverse Drug Reaction, Hypotension, DRY Skin, Chronic Obstructive Pulmonary Disease, Oedema Peripheral, Heart Rate Increased, Visual Impairment, Dizziness, Myocardial Infarction, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2007-01-04
    End date: 2007-02-03

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Start date: 2007-02-04
    End date: 2007-02-13

Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2007-02-17

Other drugs received by patient: Epivir; Viread; Valium; Aspirin; Lasix; Lexapro; Prevacid; Ziagen; Oxycontin; Neurontin; Eszopiclone; Albuterol



Possible Tracleer side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Right Ventricular Failure, Pericardial Effusion, Death, Fatigue, Skin Ulcer, Oedema Peripheral, Heart Rate Increased, Pleural Effusion, Oedema, Cough, Fluid Retention

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Revatio; Tyvaso; Furosemide W / Spironolactone



Possible Tracleer side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Dyspnoea, Cellulitis, Oedema Peripheral, Erythema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 75 year old female

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

Patient: 75 year old female

Reactions: Dyspnoea, Diabetes Mellitus, Oedema Peripheral, Oedema, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Lasix; 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 74 year old female

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

Patient: 74 year old female

Reactions: Weight Decreased, Dyspnoea, Vomiting, Nausea, Abdominal Cavity Drainage, Abdominal Pain Upper, Ascites, Oedema Peripheral, Fluid Retention, Decreased Appetite

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Coumadin



Possible Tracleer side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 78 year old female

Reactions: Back Pain, Pneumonia, Gouty Arthritis, Dyspnoea, Pain in Extremity, Heart Valve Incompetence, Anaemia, Fall, Renal Failure, Diarrhoea, Dehydration, Oedema Peripheral, Hearing Impaired, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Vascular Graft, Pain in Extremity, Peripheral Vascular Disorder, Oedema Peripheral, Hypoaesthesia, Gangrene, Peripheral Ischaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2002-11-21

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Sildenafil; Aspirin



Possible Tracleer side effects in 65 year old female

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

Patient: 65 year old female

Reactions: Death, Dyspnoea, Oedema Peripheral, Pain of Skin

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 10 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-05-12

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Sildenafil; Ventavis; Calcium Channel Blockers



Possible Tracleer side effects in 70 year old female

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

Patient: 70 year old female

Reactions: Death, Oedema Peripheral

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tracleer



Possible Tracleer side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Thrombosis, Oedema Peripheral

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2008-07-01

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Plavix; Sildenafil; Coumadin; Aspirin; Lasix



Possible Tracleer side effects in 39 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient: 39 year old female

Reactions: Pneumonia, Functional Gastrointestinal Disorder, Chest Pain, Oedema Peripheral, Pulmonary Oedema, Hypothyroidism, Fluid Retention, Pericardial Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Adcirca



Possible Tracleer side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient: 60 year old female

Reactions: Vascular Graft, Pain in Extremity, Oedema Peripheral, Peripheral Vascular Disorder, Hypoaesthesia, Gangrene, Peripheral Ischaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2002-11-21

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Aspirin; Sildenafil



Possible Tracleer side effects in 61 year old female

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

Patient: 61 year old female

Reactions: Right Ventricular Failure, Pericardial Effusion, Fatigue, Skin Ulcer, Oedema Peripheral, Heart Rate Increased, Oedema, Pleural Effusion, Cough, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Tyvaso; Revatio; Furosemide W / Spironolactone



Possible Tracleer side effects in 54 year old male

Reported by a pharmacist from United States on 2012-07-30

Patient: 54 year old male

Reactions: Dyspnoea, Oedema Peripheral, Extremity Contracture

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Tracleer
    Dosage: 31.25 mg, qd
    Administration route: Oral

Tracleer
    Dosage: 62.5 mg, qd
    Administration route: Oral



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

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient:

Reactions: Headache, Weight Increased, Surgery, Malaise, Oedema Peripheral, Skin Cancer, Musculoskeletal Stiffness, Oedema, Muscle Spasms, Fluid Retention, Back Pain, Dyspnoea, Nasal Congestion, Eye Pain, Neoplasm Malignant, Arthralgia, Lacrimation Increased

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Cialis; Procrit; Oxycodone / Acetaminophen; Adcirca



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 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 2012-07-24

Patient:

Reactions: Dyspnoea, Headache, Cardiac Disorder, Palpitations, Oedema Peripheral, Oedema, Heart Rate Irregular, Fluid Retention, Influenza

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer

Other drugs received by patient: Lasix; Oxygen; Calcium Channel Blockers



Possible Tracleer side effects in

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

Patient:

Reactions: Fluid Overload, Condition Aggravated, Pericardial Effusion, Ascites, Weight Increased, Dyspnoea Exertional, Oedema Peripheral, PH Body Fluid Abnormal, Fluid Retention, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epoprostenol Sodium
    Dosage: 47 ng/kg, per min
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-03-05

Tracleer
    Dosage: unk
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2012-05-01

Other drugs received by patient: Tadalafil; Coumadin



Possible Tracleer side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-23

Patient:

Reactions: Localised Infection, Dyspnoea, Skin Discolouration, Oedema Peripheral, Swelling, Condition Aggravated, Pleural Effusion, Laser Therapy, Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tracleer
    Dosage: 62.5 mg, bid
    Administration route: Oral
    Start date: 2011-07-13
    End date: 2011-08-01

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2011-08-01

Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2011-05-11

Tracleer
    Dosage: unk
    Administration route: Oral
    Start date: 2011-01-01

Other drugs received by patient: Crestor; Cozaar; Revatio; Simvastatin; Plavix; Spironolactone; Furosemide; Requip; Digoxin; Hydralazine HCL



Possible Tracleer side effects in

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient:

Reactions: Vomiting, Dyspnoea, Nausea, Abdominal Cavity Drainage, Ascites, Abdominal Pain Upper, Oedema Peripheral, Decreased Appetite, Fluid Retention

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tracleer
    Dosage: 125 mg, bid
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Ventavis
    Dosage: unk
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Coumadin



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