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 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 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 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 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 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 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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