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Index of reports
> Cases with Platelet Count Decreased ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tracleer (Bosentan) where reactions include platelet count decreased. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Tracleer side effects in 40 year old female
Reported by a physician from Japan on 2012-08-10
Patient: 40 year old female
Reactions: Gastrointestinal Haemorrhage, Trigeminal Neuralgia, RED Blood Cell Abnormality, Disseminated Intravascular Coagulation, Pyrexia, Circulatory Collapse, Staphylococcal Bacteraemia, Melaena, Hepatitis Fulminant, Hepatosplenomegaly, White Blood Cell Count Increased, Plasmapheresis, Anaemia, Cardiac Valve Vegetation, Alanine Aminotransferase Increased, Thrombotic Thrombocytopenic Purpura, Convulsion, Haemodialysis, Haemoglobin Decreased, Renal Impairment, Oliguria, Aspartate Aminotransferase Increased, Blood Smear Test Abnormal, Platelet Count Decreased, Transfusion, Haemorrhagic Diathesis, Altered State of Consciousness
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2008-07-10
End date: 2009-09-30
Tracleer
Dosage: 62.5 mg, qd
Administration route: Oral
Start date: 2008-07-02
End date: 2008-07-09
Prednisolone
Dosage: unk
Start date: 2007-10-01
End date: 2009-10-28
Other drugs received by patient: Beraprost Sodium; Sarpogrelate Hydrochloride; Carbocisteine; Meloxicam; Trimebutine Maleate; Omeprazole
Possible Tracleer side effects in female
Reported by a physician from Japan on 2012-07-13
Patient: female
Reactions: Gastrointestinal Haemorrhage, Trigeminal Neuralgia, RED Blood Cell Abnormality, Disseminated Intravascular Coagulation, Pyrexia, Circulatory Collapse, Staphylococcal Bacteraemia, Melaena, White Blood Cell Count Increased, Hepatitis Fulminant, Hepatosplenomegaly, Mechanical Ventilation, Alanine Aminotransferase Increased, Plasmapheresis, Anaemia, Thrombotic Thrombocytopenic Purpura, Convulsion, Haemodialysis, Haemoglobin Decreased, Renal Impairment, Oliguria, Aspartate Aminotransferase Increased, Blood Smear Test Abnormal, Transfusion, Haemorrhagic Diathesis, Platelet Count Decreased, Altered State of Consciousness, Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Prednisolone
Dosage: unk
Start date: 2007-10-01
End date: 2009-10-28
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2008-07-10
End date: 2009-09-30
Tracleer
Dosage: 62.5 mg, qd
Administration route: Oral
Start date: 2008-07-02
End date: 2008-07-09
Other drugs received by patient: Carbocisteine; Omeprazole; Sarpogrelate Hydrochloride; Beraprost Sodium; Meloxicam; Trimebutine Maleate
Possible Tracleer side effects in male
Reported by a physician from Italy on 2012-06-26
Patient: male, weighing 75.0 kg (165.0 pounds)
Reactions: Haemoglobin Decreased, White Blood Cell Count Decreased, Platelet Count Decreased, Pancytopenia
Drug(s) suspected as cause:
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2010-11-01
End date: 2010-11-30
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Digital Ulcer
Start date: 2010-12-01
End date: 2012-04-26
Other drugs received by patient: Aspirin
Possible Tracleer side effects in male
Reported by a physician from Italy on 2012-06-18
Patient: male, weighing 75.0 kg (165.0 pounds)
Reactions: Haemoglobin Decreased, White Blood Cell Count Decreased, Pancytopenia, Platelet Count Decreased
Drug(s) suspected as cause:
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2010-11-01
End date: 2010-11-30
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Digital Ulcer
Start date: 2010-12-01
End date: 2012-04-26
Other drugs received by patient: Aspirin
Possible Tracleer side effects in male
Reported by a physician from Japan on 2012-06-04
Patient: male, weighing 48.0 kg (105.6 pounds)
Reactions: Nausea, Platelet Count Decreased, Oedema, Abdominal Cavity Drainage, Ascites
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Beraprost Sodium
Tracleer
Dosage: 62.5 mg, qd
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2011-01-12
End date: 2011-01-25
Other drugs received by patient: Teprenone; Mecobalamin; Torsemide; Spironolactone; Lactulose; Lactomin; Furosemide; Olmesartan Medoxomil
Possible Tracleer side effects in
Reported by a consumer/non-health professional from United States on 2012-05-14
Patient:
Reactions: Pyrexia, Liver Transplant, Ascites, Viral Upper Respiratory Tract Infection, Hepatomegaly, Nodular Regenerative Hyperplasia, Platelet Count Decreased, Portopulmonary Hypertension, Splenomegaly, Biopsy Liver, Hepatic Cirrhosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Possible Tracleer side effects in male
Reported by a physician from Japan on 2012-05-08
Patient: male, weighing 56.0 kg (123.2 pounds)
Reactions: Hypoventilation, Thoracic Cavity Drainage, Hypercapnia, Mental Status Changes, Respiratory Depression, Gastrointestinal Tube Insertion, Interstitial Lung Disease, RED Blood Cell Count Decreased, Pneumothorax, Nocardiosis, Cough, Oxygen Saturation Decreased, White Blood Cell Count Decreased, Anaemia, Pulmonary Artery Wall Hypertrophy, Bullous Lung Disease, Haemoglobin Decreased, Pneumonia Bacterial, Enteral Nutrition, Respiratory Failure, Transfusion, Platelet Count Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: 62.5 mg, od
Administration route: Oral
Start date: 2007-06-25
End date: 2007-07-26
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2007-07-27
End date: 2008-12-08
Other drugs received by patient: Tulobuterol; Prednisolone; Sulfamethoxazole and Trimethoprim; Alendronate Sodium; Oxygen; Montelukast Sodium; Ambroxol; Isoniazid; Bakumondoto; Solifenacin Succinate; Codeine; Dextromethorphan Hydrobromide; Omeprazole; Naftopidil; Pyridoxal Phosphate; Clarithromycin; Morphine Hydrochloride; Azathioprine; Magnesium Oxide
Possible Tracleer side effects in 65 year old female
Reported by a physician from Greece on 2011-11-28
Patient: 65 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: White Blood Cell Count Decreased, Haematocrit Decreased, RED Blood Cell Count Decreased, Aplastic Anaemia, Platelet Count Decreased, Lymphocyte Count Decreased
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2011-10-20
End date: 2011-10-26
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2011-10-12
End date: 2011-10-19
Other drugs received by patient: Revatio
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2011-11-09
Patient:
Reactions: Cardiac Failure, Platelet Count Decreased
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2011-04-25
End date: 2011-10-15
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2011-03-25
End date: 2011-04-24
Epoprostenol Sodium
Dosage: 11 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2011-01-13
End date: 2011-10-15
Other drugs received by patient: Lasix; Coumadin; Sildenafil
Possible Tracleer side effects in 65 year old female
Reported by a physician from Greece on 2011-11-03
Patient: 65 year old female, weighing 60.0 kg (132.0 pounds)
Reactions: White Blood Cell Count Decreased, Haematocrit Decreased, Aplastic Anaemia, Platelet Count Decreased
Drug(s) suspected as cause:
Tracleer
Dosage: 125 mg, bid
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2011-10-20
End date: 2011-10-26
Tracleer
Dosage: 62.5 mg, bid
Administration route: Oral
Start date: 2011-10-12
End date: 2011-10-19
Other drugs received by patient: Revatio
Possible Tracleer side effects in
Reported by a physician from United States on 2011-10-21
Patient:
Reactions: Back Pain, Pneumonia, Dyspnoea, Chills, Platelet Count Decreased, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Tyvaso; Adcirca
Possible Tracleer side effects in
Reported by a pharmacist from United States on 2011-10-20
Patient:
Reactions: Death, Platelet Count Decreased
Adverse event resulted in: death
Drug(s) suspected as cause:
Epoprostenol Sodium
Dosage: 15 ng/kg, per min
Indication: Pulmonary Arterial Hypertension
Start date: 2011-01-13
End date: 2011-10-15
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2008-07-29
End date: 2011-10-15
Other drugs received by patient: Sildenafil; Lasix; Coumadin
Possible Tracleer side effects in
Reported by a physician from United States on 2011-10-13
Patient:
Reactions: Platelet Count Decreased, Pulmonary Arterial Hypertension, Disease Progression
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Vancomycin HCL; Ceftazidime; Midazolam HCL; Morphine; Aspirin; Nitric Oxide; Digoxin; Lasix; Tylenol-500; Sildenafil Citrate
Possible Tracleer side effects in
Reported by a physician from United States on 2011-10-05
Patient:
Reactions: Back Pain, Dyspnoea, Pneumonia, Chills, Platelet Count Decreased, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Tracleer
Other drugs received by patient: Adcirca
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