Tracleer combined with Warfarin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Other Serious 1/24/2006 76 Female 2/13/2006 Physician Japan
Primary
Concomitant
Liver Function Test Abnormal Other Serious 12/1/2005 51 Male 243 lb 3/3/2006 Physician United States
Primary
Concomitant
Pericardial Effusion Life Threatening 1/23/2006 12 Female 66 lb 4/14/2006 Physician Japan
Primary
Concomitant
Vomiting Other Serious 3/30/2006 59 Female 8/1/2006 Physician United States
Primary
Secondary
Concomitant
Thrombosis In Device Hospitalization 6/2/2006 36 Female 334 lb 8/18/2006 Other Health Professional United States
Primary
Concomitant
Pain In Extremity 11/22/2006 52 Female 156 lb 1/23/2007 Pharmacist United States
Primary
Concomitant
Oxygen Saturation Decreased 1/1/2005 51 Female 306 lb 1/23/2007 Pharmacist United States
Primary
Concomitant
Asthma 1/1/2005 53 Female 249 lb 1/23/2007 Other Health Professional United States
Primary
Concomitant
Breast Cancer Recurrent Hospitalization 8/27/2007 56 Female 128 lb 9/20/2007 Physician Japan
Primary
Secondary
Concomitant
Vertigo Other Serious 3/1/2009 Female 250 lb 4/29/2009 Consumer United States
Primary
Concomitant
Vertigo Other Serious 3/1/2009 Female 250 lb 6/3/2009 Consumer United States
Primary
Concomitant
Death Death 48 6/24/2009 Physician Japan
Primary
Concomitant
Pneumonia Death 5/1/2009 48 7/1/2009 Physician Japan
Primary
Concomitant
Pulmonary Hypertension Life Threatening 7/22/2008 72 7/7/2009 Physician Japan
Primary
Concomitant
Drug Interaction Other Serious 4/17/2008 38 8/3/2009 Physician Japan
Primary
Secondary
Concomitant
Swelling Other Serious 5/26/2009 26 Female 131 lb 8/7/2009 Pharmacist United States
Primary
Secondary
Concomitant
Drug Interaction Other Serious 4/17/2008 38 8/25/2009 Physician Japan
Primary
Secondary
Concomitant
Malaise Other Serious 1/1/2009 Female 98 lb 9/18/2009 Consumer United States
Primary
Concomitant
Blighted Ovum Other Serious 7/21/2009 30 Female 117 lb 12/10/2009 Physician Japan
Primary
Concomitant
Blighted Ovum Other Serious 7/21/2009 Female 117 lb 12/30/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/11/2010 32 Female 110 lb 2/22/2010 Japan
Primary
Concomitant
Pulmonary Hypertension Other Serious 11/6/2009 70 Male 148 lb 3/1/2010 Physician Japan
Primary
Concomitant
Muscular Weakness Other Serious 3/1/2010 67 Female 120 lb 4/2/2010 Consumer United States
Primary
Concomitant
Pulmonary Arterial Hypertension Other Serious 68 Female 133 lb 5/4/2010 Other Health Professional Australia
Primary
Concomitant
Muscular Weakness Other Serious 2/15/2010 67 Female 125 lb 5/7/2010 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 79 Female 5/18/2010 Lawyer United States
Primary
Concomitant
Vomiting Other Serious 72 Female 143 lb 6/10/2010 Physician Canada
Primary
Concomitant
Interacting
Monoplegia Other Serious 1/1/2007 78 Female 100 lb 6/28/2010 Consumer United States
Primary
Concomitant
Upper Airway Obstruction 6/1/2007 61 Male 190 lb 6/28/2010 Consumer United States
Primary
Concomitant
Deafness Other Serious Male 160 lb 6/29/2010 Other Health Professional United States
Primary
Concomitant
Rash 3/1/2009 75 Female 185 lb 6/29/2010 Consumer United States
Primary
Concomitant
Monoplegia Other Serious 1/1/2007 78 Female 100 lb 7/7/2010 Consumer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 79 Female 7/9/2010 United States
Primary
Concomitant
Pulmonary Oedema Hospitalization 7/21/2010 82 Female 8/11/2010 Physician Japan
Primary
Concomitant
Death Death 2/16/2009 56 Male 118 lb 8/26/2010 Physician Japan
Primary
Concomitant
Oropharyngeal Spasm Other Serious 1/1/2009 45 Male 280 lb 9/3/2010 Consumer United States
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 77 Female 9/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 2/16/2009 56 Male 118 lb 9/13/2010 Physician Japan
Primary
Concomitant
Death Death 8/13/2010 17 Female 93 lb 9/21/2010 Physician Japan
Primary
Concomitant
Deep Vein Thrombosis Hospitalization Female 9/23/2010 Physician United States
Primary
Concomitant
Respiratory Tract Infection Hospitalization 7/15/2010 76 Female 110 lb 9/28/2010 Ireland
Primary
Concomitant
Vomiting Other Serious 2/1/2008 72 Female 143 lb 10/5/2010 Physician Canada
Primary
Concomitant
Interacting
Respiratory Failure Other Serious 8/31/2010 79 Male 137 lb 10/19/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 11/12/2009 56 Female 10/19/2010 Physician Japan
Primary
Concomitant
Dizziness Other Serious 4/10/2010 74 Female 101 lb 10/29/2010 Physician Japan
Primary
Concomitant
Respiratory Arrest Life Threatening 7/26/2010 70 Female 11/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Death Death 8/13/2010 17 Female 93 lb 11/4/2010 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 11/12/2009 56 Female 11/5/2010 Physician Japan
Primary
Secondary
Concomitant
Swelling Hospitalization 83 Female 11/8/2010 Consumer United States
Primary
Concomitant
Myocardial Ischaemia Death 2/16/2009 56 Male 118 lb 11/11/2010 Physician Japan
Primary
Concomitant
Gastrointestinal Haemorrhage Death 11/8/2010 76 Female 11/14/2010 Physician Japan
Primary
Concomitant
Drug Interaction Other Serious 4/17/2008 38 Female 142 lb 11/15/2010 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 11/7/2010 11/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Tremor Hospitalization 10/1/2010 11/23/2010 Physician United States
Primary
Concomitant
Syncope Other Serious 11/11/2010 12 Male 88 lb 11/30/2010 Other Health Professional Australia
Primary
Concomitant
Respiratory Failure Other Serious 9/6/2010 79 Male 137 lb 12/2/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Death Death 11/28/2009 12/8/2010 Physician United States
Primary
Concomitant
Oropharyngeal Spasm Other Serious 1/1/2009 45 Male 280 lb 12/10/2010 Physician United States
Primary
Concomitant
Dizziness Other Serious 4/10/2010 74 Female 101 lb 12/21/2010 Physician Japan
Primary
Concomitant
Tremor Hospitalization 10/1/2010 12/21/2010 Other Health Professional United States
Primary
Concomitant
Oedema Peripheral Other Serious 1/1/2010 62 Male 278 lb 12/28/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Oedema Peripheral Other Serious 6/1/2009 50 Female 12/29/2010 Physician Israel
Primary
Concomitant
Diarrhoea Hospitalization 11/25/2010 65 Male 99 lb 1/5/2011 Physician Japan
Primary
Concomitant
Abortion Induced 35 Female 1/11/2011 Physician Turkey
Primary
Concomitant
Gastrointestinal Haemorrhage Death 11/8/2010 76 Female 73 lb 1/12/2011 Physician Japan
Primary
Concomitant
Abortion Induced 35 Female 1/13/2011 Physician Turkey
Primary
Concomitant
Drug Hypersensitivity Hospitalization 5/4/2010 70 Female 12/31/2010 United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 41 Female 201 lb 1/28/2011 Consumer United States
Primary
Concomitant
Right Ventricular Failure Other Serious 7/1/2010 43 Female 2/1/2011 Physician Japan
Primary
Concomitant
Condition Aggravated Hospitalization 1/1/2011 2/1/2011 Pharmacist United States
Primary
Secondary
Concomitant
Syncope Hospitalization 10/20/2010 2/2/2011 Pharmacist United States
Primary
Concomitant
Device Lead Damage Hospitalization 8/1/2010 2/3/2011 Other Health Professional United States
Primary
Concomitant
Central Venous Catheterisation Hospitalization 1/6/2011 2/4/2011 Pharmacist United States
Primary
Concomitant
Dyspnoea Death 3/1/2010 2/8/2011 Physician United States
Primary
Concomitant
Cardiac Operation Hospitalization 12/1/2010 2/14/2011 Pharmacist United States
Primary
Concomitant
Pregnancy Hospitalization 12/30/2002 22 Female 2/14/2011 Consumer United Kingdom
Primary
Concomitant
Catheterisation Cardiac Other Serious 23 Female 123 lb 2/14/2011 United Kingdom
Primary
Secondary
Concomitant
Pregnancy Hospitalization 12/1/2010 2/15/2011 Physician United States
Primary
Concomitant
Dizziness 4/10/2010 74 Female 101 lb 2/15/2011 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization Female 172 lb 2/17/2011 Physician Australia
Primary
Concomitant
Oedema Peripheral Other Serious 1/1/2010 62 Male 278 lb 2/23/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Fibula Fracture Other Serious 12/1/2010 2/24/2011 Consumer United States
Primary
Concomitant
Cardiac Disorder Hospitalization 11/1/2010 2/23/2011 Physician United States
Primary
Concomitant
Gastrointestinal Haemorrhage Life Threatening 5/1/2008 3/4/2011 Other Health Professional United States
Primary
Concomitant
Infection Hospitalization 1/4/2010 59 Female 107 lb 3/17/2011 Physician Japan
Primary
Concomitant
Normal Newborn Male 176 lb 3/25/2011 Physician Australia
Primary
Concomitant
Cardiac Failure Death 10/18/2010 38 Male 139 lb 3/29/2011 Physician Japan
Primary
Concomitant
Insomnia Hospitalization 2/1/2010 4/11/2011 Consumer United States
Primary
Concomitant
Anaemia Other Serious 3/1/2011 89 Female 104 lb 4/12/2011 Consumer United States
Primary
Concomitant
Pulmonary Congestion Hospitalization 9/1/2010 4/15/2011 Physician United States
Primary
Concomitant
Oedema Peripheral Hospitalization 2/1/2010 4/19/2011 Consumer United States
Primary
Concomitant
Catheter Placement Hospitalization 12/1/2010 4/20/2011 Pharmacist United States
Primary
Concomitant
Resuscitation Other Serious 23 Female 123 lb 4/27/2011 United Kingdom
Primary
Secondary
Concomitant
Chills Death 3/6/2011 4/29/2011 Physician United States
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 1/1/2011 5/2/2011 Other Health Professional United States
Primary
Concomitant
Gastric Cancer Death 1/26/2010 70 Male 108 lb 5/2/2011 Physician Japan
Primary
Concomitant
Dizziness Hospitalization 1/1/2010 76 Female 5/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Blood Potassium Decreased Life Threatening 3/1/2010 5/10/2011 Physician United States
Primary
Secondary
Concomitant
Device Related Sepsis Hospitalization 12/23/2009 5/10/2011 Physician United States
Primary
Concomitant
Sudden Death Death 10/18/2009 22 Male 93 lb 5/26/2011 Physician Japan
Primary
Concomitant
Death Hospitalization 5/27/2010 57 Female 126 lb 5/30/2011 Physician Japan
Primary
Concomitant
Hepatomegaly Other Serious 3/1/2011 89 Female 104 lb 6/2/2011 Physician United States
Primary
Concomitant
Tachycardia Hospitalization 7/29/2010 71 Female 84 lb 6/6/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 1/26/2010 70 Male 108 lb 6/10/2011 Physician Japan
Primary
Concomitant
Pulmonary Hypertension Hospitalization 5/27/2010 57 Female 126 lb 7/21/2011 Physician Japan
Primary
Concomitant
Pulmonary Thrombosis Death 7/5/2010 73 Male 7/28/2011 Physician Japan
Primary
Concomitant
Vomiting Death 7/6/2011 53 Female 8/10/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Cardiac Arrest Death 7/31/2011 71 Male 247 lb 8/11/2011 Other Health Professional Australia
Primary
Concomitant
Pulmonary Hypertension Death 10/18/2009 22 Male 93 lb 10/11/2011 Physician Japan
Primary
Concomitant
Balloon Atrial Septostomy Death 38 Female 112 lb 12/28/2011 Physician Russian Federation
Primary
Concomitant
Headache Hospitalization 6/13/2009 10 Female 48 lb 12/30/2011 Physician Japan
Primary
Concomitant
Malaise Hospitalization 6/13/2009 10 Female 48 lb 1/27/2012 Physician Japan
Primary
Concomitant
Hepatosplenomegaly Other Serious 1/1/2011 2/17/2012 Other Health Professional United States
Primary
Concomitant
Pulmonary Thrombosis Other Serious 3/6/2012 7 Male 4/13/2012 Pharmacist Japan
Primary
Secondary
Concomitant
Activities Of Daily Living Impaired Other Serious Male 293 lb 6/7/2012 Consumer United States
Primary
Concomitant
Visual Impairment Other Serious Male 293 lb 7/27/2012 Consumer United States
Primary
Concomitant
Right Ventricular Failure Other Serious 7/2010 43 Female 3/5/2013 Physician Jp
Primary
Concomitant
Pyrexia Other Serious 10/2005 77 Female 160 lb 12/21/2012 Other Health Professional Us
Primary
Concomitant
Staphylococcal Bacteraemia Hospitalization 10/2011 45 Female 9/6/2012 Physician Us
Primary
Concomitant
Pneumonia Life Threatening 2/2012 69 Female 135 lb 11/5/2012 Pharmacist Us
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/3/2012 39 Female 209 lb 10/1/2012 Physician Jp
Primary
Secondary
Concomitant
Vena Cava Filter Insertion Other Serious 8/22/2012 61 Male 10/16/2012 Physician Us
Primary
Concomitant
Transfusion Hospitalization 7/2011 85 Female 10/11/2012 Pharmacist Us
Primary
Concomitant
Death Death Female 9/11/2012 Consumer Us
Primary
Concomitant
Thrombocytopenic Purpura Other Serious 5/8/2012 48 Female 10/5/2012 Physician Ir
Primary
Secondary
Concomitant
Terminal State Death 50 Female 11/26/2012 Physician Gb
Primary
Concomitant
Tibia Fracture Hospitalization 9/2010 53 Female 2/19/2013 Pharmacist Us
Primary
Concomitant
Ulcer Haemorrhage Other Serious 3/22/2011 78 Female 10/1/2012 Pharmacist Us
Primary
Concomitant
Right Ventricular Failure Hospitalization Female 148 lb 12/26/2012 Physician Us
Primary
Concomitant
Pulmonary Arterial Pressure Increased Other Serious 8/2006 68 Female 126 lb 1/8/2013 Physician Us
Primary
Secondary
Concomitant
Splenic Infarction Hospitalization 9/6/2012 60 Male 152 lb 11/29/2012 Physician Jp
Primary
Concomitant
Subdural Haematoma Hospitalization 10/9/2011 75 Female 115 lb 12/28/2012 Physician Jp
Primary
Secondary
Concomitant
Wound Hospitalization 61 Female 150 lb 9/28/2012 Consumer Us
Primary
Concomitant
No Therapeutic Response Death 9/27/2012 76 Female 10/3/2012 Consumer Us
Primary
Secondary
Concomitant
Liver Disorder Other Serious 8/3/2012 39 Female 10/3/2012 Physician Jp
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 2/2012 42 Female 10/22/2012 Physician Us
Primary
Secondary
Concomitant
Pulmonary Hypertension Hospitalization 8 Female 10/22/2012 Physician Us
Primary
Concomitant
Death Death 10/16/2012 77 Male 11/3/2012 Physician Us
Primary
Concomitant
Visual Acuity Reduced Death 10/29/2012 57 Female 121 lb 12/27/2012 Pharmacist Us
Primary
Concomitant
Post Procedural Haematoma Hospitalization 9/21/2012 69 Female 132 lb 12/5/2012 Other Health Professional Au
Primary
Concomitant
Uterine Dilation And Evacuation Other Serious 27 Male 1/8/2013 Physician Jp
Primary
Secondary
Concomitant
Arrhythmia Other Serious 10/2011 45 Male 120 lb 12/20/2012 Consumer Us
Primary
Concomitant
Pulmonary Hypertension Other Serious 2012 46 Male 120 lb 1/21/2013 Consumer Us
Primary
Concomitant
Pneumonia Other Serious 12/26/2012 66 Female 200 lb 2/13/2013 Consumer Us
Primary
Concomitant
Cardiopulmonary Failure Death 52 Female 1/16/2013 Consumer Ru
Primary
Concomitant
Sneezing Hospitalization 12/21/2012 48 Male 3/5/2013 Consumer Ca
Primary
Concomitant
Death Death 1/3/2013 80 Female 1/31/2013 Other Health Professional Au
Primary
Concomitant
Vascular Stenosis Hospitalization 1/2012 68 Female 1/31/2013 Physician Jp
Primary
Concomitant
Thyroid Function Test Abnormal Hospitalization 2011 79 Female 2/19/2013 Physician Us
Primary
Secondary
Concomitant
Oral Mucosal Blistering 2/6/2013 Male 2/14/2013 Consumer Us
Primary
Concomitant

Drug Data