Flolan combined with Tracleer

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Aspartate Aminotransferase Increased Other Serious 10/4/2005 19 Female 1/18/2006 Sweden
Primary
Concomitant
Vaginal Haemorrhage Other Serious 10/19/2004 23 Female 111 lb 1/23/2006 Physician United States
Primary
Concomitant
Pregnancy Other Serious 1/1/2004 41 Female 1/25/2006 Physician United States
Primary
Concomitant
Ventricular Septal Defect Required Intervention 5/8/2005 Male 1/27/2006 Physician United States
Primary
Concomitant
Troponin I Increased Other Serious 11/3/2005 35 Male 170 lb 2/6/2006 Physician United States
Primary
Secondary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 10/4/2005 19 Female 2/17/2006 Sweden
Primary
Concomitant
Ventricular Dysfunction Required Intervention 10/12/2004 14 Female 108 lb 3/9/2006 Physician United States
Primary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 10/4/2005 19 Female 3/23/2006 Sweden
Primary
Concomitant
Vomiting Other Serious 1/1/2005 54 Male 3/24/2006 Physician Belgium
Primary
Concomitant
Pericardial Effusion Life Threatening 1/23/2006 12 Female 66 lb 4/14/2006 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 10/1/2004 54 Female 143 lb 4/10/2006 Physician United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 10/4/2005 19 Female 4/19/2006 Sweden
Primary
Concomitant
Pulmonary Hypertension Death 61 Female 121 lb 5/12/2006 Consumer United States
Primary
Secondary
Concomitant
Headache 7/1/2002 21 Female 5/23/2006 Physician United States
Primary
Secondary
Flushing 50 Female 5/23/2006 Physician United States
Primary
Secondary
Headache 8/1/2005 30 Male 5/23/2006 Physician United States
Primary
Secondary
Concomitant
Vomiting Other Serious 8/12/2005 54 Male 187 lb 6/30/2006 Other Health Professional Belgium
Primary
Concomitant
Asthma Hospitalization 10/6/2005 31 Female 7/18/2006 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 8/12/2005 54 Male 187 lb 7/14/2006 Other Health Professional Belgium
Primary
Concomitant
Scleroderma Other Serious 7/2/2005 41 Female 115 lb 7/19/2006 Physician Japan
Primary
Secondary
Concomitant
Right Ventricular Failure Other Serious 7/31/2004 26 Female 149 lb 7/24/2006 Physician Japan
Primary
Secondary
Concomitant
Scleroderma Other Serious 7/2/2005 41 Female 115 lb 7/24/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 3/1/2006 51 Female 7/25/2006 Other Health Professional Canada
Primary
Concomitant
Hypersensitivity Disability 61 Female 121 lb 8/9/2006 Consumer United States
Primary
Secondary
Concomitant
Scleroderma Other Serious 7/2/2005 41 Female 115 lb 8/4/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 5/23/2004 51 Female 8/7/2006 Other Health Professional Canada
Primary
Concomitant
Diarrhoea Other Serious 3/23/2006 65 Female 8/14/2006 Physician United States
Primary
Secondary
Hepatic Enzyme Increased Other Serious 3/23/2006 65 Female 8/24/2006 Physician United States
Primary
Secondary
Premature Baby Other Serious 7/18/2006 Male 10/3/2006 Physician United Kingdom
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 8/19/2006 4 Male 10/9/2006 Physician Japan
Primary
Secondary
Weight Decreased Hospitalization 7/31/2004 26 Female 149 lb 11/30/2006 Physician Japan
Primary
Secondary
Concomitant
Off Label Use 41 Female 115 lb 11/30/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 21 Female 121 lb 12/22/2006 Physician United States
Primary
Concomitant
Oedema Peripheral Other Serious 8/8/2006 64 Female 1/30/2007 Physician United States
Primary
Secondary
Concomitant
Embolism Other Serious 1/25/2007 54 Male 164 lb 2/6/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint 2/1/2007 39 Female 148 lb 2/23/2007 Consumer United States
Primary
Concomitant
Red Blood Cell Schistocytes Present Other Serious 8/8/2006 64 Female 2/23/2007 Physician United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/29/2007 39 Female 148 lb 3/2/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/14/2007 37 Male 209 lb 3/7/2007 Consumer United States
Primary
Concomitant
Supraventricular Tachycardia Other Serious 1/19/2006 39 Female 3/8/2007 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/29/2007 39 Female 148 lb 3/12/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 2/14/2007 9 Female 43 lb 3/15/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/18/2007 58 Female 167 lb 3/15/2007 Consumer United States
Primary
Concomitant
Sepsis Other Serious 12/21/2006 51 Male 205 lb 3/26/2007 Other Health Professional United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 2/5/2007 39 Female 148 lb 3/28/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 7/18/2000 9 Female 43 lb 3/28/2007 Consumer United States
Primary
Concomitant
Vomiting Required Intervention 6/23/2005 36 Female 90 lb 3/20/2007 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 7/18/2000 9 Female 43 lb 4/3/2007 Consumer United States
Primary
Concomitant
Pharmaceutical Product Complaint Other Serious 1/14/2007 37 Male 209 lb 4/17/2007 Consumer United States
Primary
Concomitant
Sepsis Other Serious 12/21/2006 51 Male 205 lb 4/17/2007 Other Health Professional United States
Primary
Concomitant
Right Ventricular Failure Hospitalization 1/1/2006 Female 196 lb 4/25/2007 Physician France
Primary
Secondary
Concomitant
Malaise Life Threatening 4/4/2007 65 Female 148 lb 5/11/2007 Consumer France
Primary
Concomitant
Infection Life Threatening 9/9/2004 31 Female 110 lb 5/15/2007 Physician Japan
Primary
Secondary
Concomitant
Malaise Life Threatening 1/1/2007 65 Female 148 lb 5/18/2007 Consumer France
Primary
Concomitant
Pyrexia Life Threatening 9/9/2004 31 Female 110 lb 5/21/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Required Intervention 6/23/2005 36 Female 90 lb 6/4/2007 Physician Japan
Primary
Secondary
Concomitant
Tubal Ligation Other Serious 1/1/2006 31 Female 6/5/2007 Physician United States
Primary
Concomitant
Disease Progression Death 7 Female 44 lb 6/19/2007 Pharmacist Ireland
Primary
Concomitant
Disease Progression Death 7 Female 44 lb 6/27/2007 Pharmacist Ireland
Primary
Concomitant
Disease Progression Death 7 Female 44 lb 7/2/2007 Pharmacist Ireland
Primary
Concomitant
Hypoxia Life Threatening 6/18/2006 24 Female 93 lb 7/9/2007 Consumer Japan
Primary
Concomitant
Shock Life Threatening 8/1/2007 Female 8/24/2007 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 10/30/2004 30 Female 8/31/2007 Physician Japan
Primary
Concomitant
Wound Secretion Other Serious 7/30/2007 32 Female 183 lb 9/17/2007 Physician United States
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 3/8/2007 54 Male 9/19/2007 Physician United States
Primary
Concomitant
Lung Transplant Other Serious 53 Female 112 lb 10/16/2007 Other Health Professional Belgium
Primary
Concomitant
Pleural Fibrosis Other Serious 1/1/2007 53 Female 194 lb 10/16/2007 Other Health Professional Belgium
Primary
Concomitant
Hepatic Congestion Hospitalization 44 Female 10/23/2007 Physician France
Primary
Concomitant
Subdural Haematoma Other Serious 10/1/2006 53 Female 112 lb 10/30/2007 Other Health Professional Belgium
Primary
Concomitant
Pneumonia Bacterial Other Serious 1/1/2007 53 Female 194 lb 10/30/2007 Other Health Professional Belgium
Primary
Concomitant
Shock Other Serious 7/30/2007 40 Female 11/8/2007 Physician Japan
Primary
Concomitant
Thyroid Disorder Hospitalization 4/1/2006 15 Female 11/13/2007 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/20/2005 17 Female 11/14/2007 Physician Japan
Primary
Secondary
Concomitant
Hypothalamo-pituitary Disorder Hospitalization 7/1/2007 41 Female 11/14/2007 Physician Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 3/28/2006 41 Female 11/21/2007 Physician Japan
Primary
Concomitant
Thrombocytopenia Hospitalization 3/28/2006 41 Female 11/28/2007 Physician Japan
Primary
Concomitant
Cytolytic Hepatitis Hospitalization 44 Female 12/3/2007 Physician France
Primary
Concomitant
Cytolytic Hepatitis Hospitalization 44 Female 12/19/2007 Physician France
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 12/19/2007 80 Female 12/27/2007 Consumer United States
Primary
Concomitant
Hepatic Function Abnormal Other Serious 10/31/2007 Female 1/3/2008 Physician Japan
Primary
Secondary
Concomitant
Thyroid Disorder Hospitalization 4/1/2006 15 Female 1/8/2008 Physician Japan
Primary
Concomitant
Sepsis Other Serious 8/20/2005 17 Female 1/9/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 3/28/2006 41 Female 1/11/2008 Physician Japan
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 12/19/2007 80 Female 1/21/2008 Consumer United States
Primary
Concomitant
Eosinophilic Pneumonia Other Serious 2/15/2008 22 Female 2/29/2008 Physician Japan
Primary
Concomitant
Pleural Effusion Hospitalization 2/7/2007 21 Female 3/7/2008 Physician Japan
Primary
Secondary
Concomitant
Swelling Face Other Serious 2/15/2008 Female 97 lb 3/14/2008 Physician Japan
Primary
Secondary
Concomitant
Swelling Face Hospitalization 2/7/2007 21 Female 3/19/2008 Physician Japan
Primary
Secondary
Concomitant
Swelling Face Other Serious 2/15/2008 Female 97 lb 3/27/2008 Physician Japan
Primary
Secondary
Concomitant
Swelling Face Hospitalization 2/7/2007 21 Female 4/7/2008 Physician Japan
Primary
Secondary
Concomitant
Productive Cough Hospitalization 5/2/2006 39 Male 4/24/2008 Physician Japan
Primary
Concomitant
Duodenal Ulcer Hospitalization 9/9/2006 36 Male 4/24/2008 Physician Japan
Primary
Concomitant
Productive Cough Hospitalization 5/2/2006 39 Male 5/21/2008 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 5/2/2006 39 Male 5/27/2008 Physician Japan
Primary
Concomitant
Rash 74 Female 5/30/2008 Consumer United States
Primary
Concomitant
Pain In Jaw 5/30/2007 62 Male 262 lb 5/30/2008 Consumer United States
Primary
Concomitant
Viral Infection Life Threatening 8/19/2006 4 Male 6/10/2008 Physician Japan
Primary
Secondary
Concomitant
Supraventricular Tachycardia Other Serious 1/19/2006 39 Female 6/11/2008 Physician Japan
Primary
Secondary
Concomitant
Syncope Other Serious 4/9/2004 25 Female 142 lb 6/12/2008 Physician United States
Primary
Concomitant
Cardiac Failure Death 1/16/2007 52 Female 90 lb 6/24/2008 Physician Japan
Primary
Concomitant
Ventricular Dysfunction Required Intervention 10/12/2004 14 Female 108 lb 6/26/2008 Physician United States
Primary
Concomitant
Hypoxia Life Threatening 6/18/2006 24 Female 93 lb 8/5/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Death 6/19/2007 56 Female 112 lb 8/5/2008 Physician Japan
Primary
Concomitant
Vomiting Death 7/11/2008 62 Female 154 lb 8/6/2008 Consumer France
Primary
Secondary
Concomitant
Sudden Death Hospitalization 1/11/2006 47 Female 8/8/2008 Physician Japan
Primary
Concomitant
Sudden Death Death 7/14/2008 62 Female 8/13/2008 Other Health Professional France
Primary
Secondary
Concomitant
Vomiting Death 6/1/2008 62 Female 154 lb 8/14/2008 Physician France
Primary
Secondary
Right Ventricular Failure Other Serious 1/1/2007 38 Male 8/15/2008 Physician United States
Primary
Concomitant
Duodenal Ulcer Hospitalization 9/9/2006 36 Male 9/2/2008 Physician Japan
Primary
Secondary
Sudden Death Hospitalization 1/11/2006 47 Female 9/3/2008 Physician Japan
Primary
Concomitant
Thyroid Disorder Hospitalization 4/1/2006 15 Female 9/11/2008 Physician Japan
Primary
Concomitant
Hypoxia Life Threatening 6/18/2006 24 Female 93 lb 9/15/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Life Threatening 6/19/2007 56 Female 112 lb 9/15/2008 Physician Japan
Primary
Concomitant
Lung Transplant Rejection Hospitalization 4/27/2006 53 Female 9/23/2008 Physician Japan
Primary
Secondary
Concomitant
Haemoptysis Death 5/6/2007 18 Female 10/1/2008 Physician Japan
Primary
Secondary
Concomitant
Lung Transplant Rejection Hospitalization 4/27/2006 53 Female 10/9/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Life Threatening 9/23/2004 22 Male 10/15/2008 Physician Japan
Primary
Concomitant
Skin Hyperpigmentation Hospitalization 1/1/2008 65 Male 148 lb 10/21/2008 Physician France
Primary
Secondary
Concomitant
Nausea Other Serious 9/20/2008 52 Female 104 lb 10/22/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 5/23/2004 51 Female 10/22/2008 Other Health Professional Canada
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 15 Female 11/19/2008 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Life Threatening 9/23/2004 22 Male 11/19/2008 Physician Japan
Primary
Concomitant
Hepatic Failure Death 5/5/2008 12/17/2008 Physician Japan
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 15 Female 12/30/2008 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 6/1/2008 1/5/2009 Physician Japan
Primary
Concomitant
Splenomegaly Hospitalization 67 Female 1/23/2009 Consumer United States
Primary
Concomitant
Liver Disorder Hospitalization 6/1/2008 2/9/2009 Physician Japan
Primary
Secondary
Concomitant
Scrotal Oedema Hospitalization 1/7/2009 73 Male 2/5/2009 Physician Sweden
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 8/5/2008 28 Female 2/27/2009 Physician Japan
Primary
Secondary
Pulmonary Congestion Life Threatening 6/22/2008 55 Male 3/2/2009 Physician Japan
Primary
Concomitant
Thyroiditis Hospitalization 1/1/2004 3/10/2009 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Congestion Life Threatening 6/22/2008 55 Male 137 lb 3/19/2009 Physician Japan
Primary
Concomitant
Splenomegaly Hospitalization 1/1/2009 67 Female 4/6/2009 Consumer United States
Primary
Concomitant
Right Ventricular Failure Hospitalization 12/5/2008 43 Female 4/15/2009 Physician United States
Primary
Concomitant
Atrial Fibrillation Hospitalization 8/5/2008 Female 4/29/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting 1/1/2008 69 Female 119 lb 5/29/2009 Consumer United States
Primary
Concomitant
Weight Increased Hospitalization 4/1/2006 Female 6/1/2009 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 1/21/2002 Female 6/4/2009 Physician Japan
Primary
Concomitant
Subcutaneous Abscess Hospitalization 9/22/2002 Female 6/9/2009 Physician Japan
Primary
Concomitant
Hypoxia Life Threatening 6/18/2006 24 Female 93 lb 6/15/2009 Consumer Japan
Primary
Concomitant
Hypoxia Life Threatening 6/18/2006 Female 93 lb 6/15/2009 Physician Japan
Primary
Concomitant
Upper Respiratory Tract Congestion Life Threatening 5/1/2009 15 Female 6/12/2009 Physician United States
Primary
Concomitant
Oedema Peripheral Hospitalization 4/29/2008 41 Male 6/11/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Life Threatening 9/23/2004 Male 7/1/2009 Physician Japan
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 9/22/2002 Female 7/24/2009 Physician Japan
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 8/1/2004 27 Female 7/27/2009 Physician Spain
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 9/22/2002 Female 8/3/2009 Physician Japan
Primary
Concomitant
Pregnancy Other Serious 9/1/2008 29 Female 7/29/2009 Pharmacist United States
Primary
Concomitant
Haemorrhagic Stroke Hospitalization 6/16/2009 77 Female 8/4/2009 Other Health Professional United States
Primary
Secondary
Swelling Other Serious 5/26/2009 26 Female 131 lb 8/7/2009 Pharmacist United States
Primary
Secondary
Concomitant

Drug Data