Prednisolone combined with Tracleer

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rash Other Serious 60 Female 1/6/2006 Physician Australia
Primary
Concomitant
Platelet Count Decreased Other Serious 11/4/2005 72 Female 97 lb 1/18/2006 Physician Japan
Primary
Secondary
Concomitant
Rash Papular Hospitalization 9/16/2005 59 Female 105 lb 1/25/2006 Physician Japan
Primary
Concomitant
Vomiting Life Threatening 7/1/2005 67 Female 115 lb 2/13/2006 Physician France
Primary
Concomitant
Shock Other Serious 11/4/2005 72 Female 97 lb 2/23/2006 Physician Japan
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious Female 132 lb 3/28/2006 United Kingdom
Primary
Concomitant
Vestibular Disorder Hospitalization 12/1/2004 56 Female 6/13/2006 Physician Germany
Primary
Concomitant
Rash Generalised Hospitalization 9/16/2005 59 Female 105 lb 6/30/2006 Physician Japan
Primary
Concomitant
Right Ventricular Failure Other Serious 6/12/2004 45 Female 115 lb 7/24/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Death 1/1/2006 76 Male 8/23/2006 Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 3/24/2006 47 Female 90 lb 8/28/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Hospitalization 7/4/2006 58 Female 155 lb 9/12/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Pneumonia Other Serious 8/29/2006 18 Female 130 lb 9/25/2006 Physician Japan
Primary
Secondary
Concomitant
Hepatitis Acute Other Serious 5/1/2006 45 Female 100 lb 10/6/2006 Physician Australia
Primary
Secondary
Concomitant
Pneumonia Other Serious 2/27/2006 62 Female 101 lb 10/6/2006 Japan
Primary
Concomitant
Lymphoma Death 6/10/2006 66 Female 126 lb 10/6/2006 Physician Japan
Primary
Concomitant
Portal Vein Thrombosis Death 6/10/2006 66 Female 126 lb 10/18/2006 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 8/24/2006 18 Female 130 lb 10/18/2006 Physician Japan
Primary
Secondary
Concomitant
Malabsorption Other Serious 5/1/2006 45 Female 100 lb 10/23/2006 Physician Australia
Primary
Secondary
Concomitant
Malabsorption Other Serious 5/1/2006 45 Female 100 lb 11/6/2006 Physician Australia
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 10/31/2006 70 Female 11/16/2006 Physician Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Other Serious 5/1/2006 45 Female 100 lb 11/20/2006 Physician Australia
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 9/30/2006 48 Female 95 lb 11/28/2006 Japan
Primary
Concomitant
Tachycardia Life Threatening 10/31/2006 70 Female 95 lb 11/28/2006 Japan
Primary
Secondary
Concomitant
Right Ventricular Failure 45 Female 115 lb 11/30/2006 Physician Japan
Primary
Concomitant
Pneumonia Other Serious 2/27/2006 62 Female 101 lb 12/6/2006 Japan
Primary
Concomitant
Tachycardia Life Threatening 10/31/2006 70 Female 95 lb 1/3/2007 Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 8/16/2006 63 Female 101 lb 2/6/2007 Japan
Primary
Concomitant
Drug Level Decreased Life Threatening 1/1/2007 61 Male 163 lb 3/16/2007 Physician Germany
Primary
Secondary
Concomitant
Immunosuppressant Drug Level Decreased Life Threatening 1/1/2007 61 Male 163 lb 3/27/2007 Physician Germany
Primary
Secondary
Concomitant
White Blood Cells Urine Positive Death 3/3/2007 28 Female 127 lb 3/23/2007 Other Health Professional Japan
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 8/16/2006 63 Female 101 lb 3/30/2007 Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 5/1/2006 45 Female 100 lb 4/12/2007 Physician Australia
Primary
Secondary
Concomitant
Sepsis Required Intervention 3/29/2007 58 Female 132 lb 5/8/2007 Physician Germany
Primary
Concomitant
Sudden Death Death 4/29/2007 79 Female 154 lb 5/24/2007 Netherlands
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 3/4/2007 29 Female 117 lb 5/29/2007 Physician Korea, Republic Of
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 3/3/2007 28 Female 127 lb 5/30/2007 Physician Japan
Primary
Concomitant
Coronary Artery Disease Death 75 Female 7/9/2007 Physician Germany
Primary
Concomitant
Right Ventricular Failure Other Serious 7/21/2005 44 Male 143 lb 7/26/2007 Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Death 3/3/2007 28 Female 127 lb 7/24/2007 Physician Japan
Primary
Concomitant
Histiocytosis Haematophagic Death 3/3/2007 Female 127 lb 10/26/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 2/26/2007 43 Female 77 lb 3/11/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 2/26/2007 43 Female 77 lb 4/8/2008 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 11/30/2005 86 Female 104 lb 5/30/2008 Consumer Japan
Primary
Concomitant
Death Death 5/18/2008 108 lb 9/30/2008 Japan
Primary
Concomitant
Cardiac Failure Death 5/18/2008 Female 108 lb 10/10/2008 Japan
Primary
Concomitant
Pulmonary Arterial Hypertension Death 8/20/2006 66 Female 159 lb 12/3/2008 Physician Japan
Primary
Secondary
Concomitant
Tenderness Hospitalization 10/8/2008 62 Female 97 lb 12/15/2008 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 7/31/2008 1/6/2009 Physician Japan
Primary
Concomitant
Tenderness Hospitalization 9/24/2008 62 Female 97 lb 1/5/2009 Physician Japan
Primary
Concomitant
Systemic Lupus Erythematosus Other Serious 2/13/2008 28 Female 115 lb 4/3/2009 Physician Japan
Primary
Concomitant
Respiratory Distress Hospitalization 1/1/2009 34 Female 117 lb 5/20/2009 Germany
Primary
Concomitant
Paraesthesia Hospitalization 1/1/2009 34 Female 117 lb 5/29/2009 Germany
Primary
Concomitant
Sepsis Death 5/3/2009 73 Female 6/17/2009 Physician Germany
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
Viral Infection Other Serious 1/1/2009 34 Female 117 lb 7/21/2009 Physician Germany
Primary
Concomitant
Pancytopenia Other Serious 4/15/2009 61 Female 7/28/2009 Japan
Primary
Concomitant
Weight Increased Hospitalization 3/1/2009 45 Female 9/4/2009 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 11/10/2007 78 Male 123 lb 9/17/2009 Consumer Japan
Primary
Concomitant
Histiocytosis Haematophagic Death 3/3/2007 Female 127 lb 11/30/2009 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 8/13/2008 54 Female 132 lb 12/3/2009 Korea, Republic Of
Primary
Concomitant
Rebound Effect Life Threatening 4/24/2008 42 Female 134 lb 12/11/2009 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Arterial Hypertension Other Serious 5/11/2008 54 Female 132 lb 12/22/2009 Physician Korea, Republic Of
Primary
Concomitant
Ear Discomfort Disability 12/6/2009 76 Male 12/22/2009 Physician United Kingdom
Primary
Concomitant
Rebound Effect Life Threatening 4/24/2008 42 Female 134 lb 1/27/2010 Physician Japan
Primary
Secondary
Concomitant
Systemic Sclerosis Required Intervention 10/1/2009 60 Female 1/28/2010 Physician Germany
Primary
Concomitant
Death Death 12/20/2009 45 Female 86 lb 2/16/2010 Physician Japan
Primary
Concomitant
Ear Discomfort Disability 12/6/2009 76 Male 2/9/2010 Other Health Professional United Kingdom
Primary
Concomitant
Viral Infection Other Serious 1/1/2009 34 Female 117 lb 2/11/2010 Germany
Primary
Concomitant
Right Ventricular Failure Other Serious 12/20/2009 45 Female 86 lb 3/2/2010 Physician Japan
Primary
Concomitant
Pneumothorax Other Serious 7/6/2007 73 Male 3/3/2010 Japan
Primary
Concomitant
Viral Infection Other Serious 2/2/2009 34 Female 117 lb 3/4/2010 Germany
Primary
Concomitant
Interstitial Lung Disease Other Serious 6/30/2007 70 Male 3/16/2010 Other Health Professional Japan
Primary
Concomitant
Viral Infection Other Serious 2/2/2009 34 Female 117 lb 3/18/2010 Germany
Primary
Concomitant
Dyspnoea Exertional Hospitalization 1/13/2010 67 Female 98 lb 4/27/2010 Physician Japan
Primary
Concomitant
Hepatic Cirrhosis Hospitalization 1/1/2009 78 Female 154 lb 4/27/2010 Other Health Professional Denmark
Primary
Concomitant
Ventricular Septal Defect Other Serious 5/26/2008 1 Male 9 lb 4/30/2010 Japan
Primary
Secondary
Concomitant
Viral Infection Hospitalization 5/14/2010 64 Male 5/24/2010 Japan
Primary
Concomitant
Pneumothorax Other Serious 7/6/2007 73 Male 6/2/2010 Japan
Primary
Concomitant
Pyrexia Hospitalization 5/4/2010 64 Male 6/4/2010 Japan
Primary
Concomitant
Pyrexia Hospitalization 5/13/2010 64 Female 95 lb 6/17/2010 Japan
Primary
Concomitant
Hepatic Cirrhosis Hospitalization 1/1/2009 78 Female 154 lb 6/22/2010 Denmark
Primary
Concomitant
Sepsis Hospitalization 60 Female 7/6/2010 Other Health Professional Israel
Primary
Concomitant
Weight Increased Other Serious 1/1/2008 75 Female 106 lb 7/26/2010 Japan
Primary
Secondary
Pulmonary Arterial Hypertension Other Serious 8/13/2008 54 Female 132 lb 7/28/2010 Korea, Republic Of
Primary
Concomitant
Renal Impairment Other Serious 12/1/2007 75 Female 106 lb 8/5/2010 Japan
Primary
Secondary
Pyrexia Hospitalization 5/13/2010 64 Female 95 lb 8/24/2010 Japan
Primary
Concomitant
Skin Ulcer Required Intervention 10/1/2009 60 Female 143 lb 8/31/2010 Germany
Primary
Concomitant
Pyrexia Hospitalization 5/13/2010 64 Female 95 lb 9/20/2010 Japan
Primary
Concomitant
Systemic Lupus Erythematosus Hospitalization 7/23/2008 36 Female 139 lb 9/28/2010 Japan
Primary
Concomitant
Right Ventricular Failure Hospitalization 10/1/2009 70 Female 10/25/2010 Physician Japan
Primary
Concomitant
Renal Failure Acute Hospitalization 7/24/2010 77 Male 164 lb 10/26/2010 Other Health Professional Australia
Primary
Concomitant
Infection Hospitalization 1/4/2010 60 Female 107 lb 10/28/2010 Physician Japan
Primary
Concomitant
Ventricular Fibrillation Other Serious 7/13/2008 14 Female 79 lb 11/3/2010 Physician Japan
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 2/16/2009 56 Male 118 lb 11/11/2010 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 65 Female 11/30/2010 Physician Israel
Primary
Concomitant
Underweight Death 1/20/2008 64 Female 88 lb 12/6/2010 Physician Thailand
Primary
Concomitant
Alanine Aminotransferase Increased 2/16/2010 60 Female 1/10/2011 Japan
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 12/1/2010 65 Female 143 lb 1/26/2011 Physician Belgium
Primary
Concomitant
Cardiac Failure Death 59 Male 2/3/2011 Physician Japan
Primary
Concomitant
Concomitant Disease Aggravated Other Serious 5/26/2010 73 Female 128 lb 2/3/2011 Physician Japan
Primary
Concomitant
Stress Fracture Other Serious 10/1/2009 56 Female 2/14/2011 Other Health Professional Sweden
Primary
Concomitant
Rheumatoid Arthritis Other Serious 1/10/2011 57 Female 2/16/2011 Physician Germany
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 10/13/2009 37 Female 98 lb 2/22/2011 Physician Korea, Republic Of
Primary
Concomitant
Parenteral Nutrition Hospitalization 10/15/2009 50 Female 88 lb 2/24/2011 Physician Japan
Primary
Concomitant
Aspartate Aminotransferase Increased 10/13/2009 37 Female 98 lb 3/16/2011 Physician Korea, Republic Of
Primary
Concomitant
Concomitant Disease Aggravated Hospitalization 7/12/2010 68 Female 134 lb 3/21/2011 Physician Japan
Primary
Concomitant
Systemic Lupus Erythematosus Hospitalization 7/23/2008 36 Female 139 lb 4/7/2011 Physician Japan
Primary
Concomitant
Headache Other Serious 1/26/2011 80 Female 4/11/2011 Pharmacist Netherlands
Primary
Concomitant
Blood Alkaline Phosphatase Increased Hospitalization 4/18/2008 80 Female 82 lb 4/26/2011 Physician Japan
Primary
Concomitant
Arthritis Other Serious 10/1/2009 56 Female 4/27/2011 Other Health Professional Sweden
Primary
Concomitant
Blood Bilirubin Increased Hospitalization 1/1/2011 51 Female 187 lb 5/9/2011 Physician Germany
Primary
Secondary
Concomitant
Infection Hospitalization 1/4/2010 59 Female 107 lb 5/25/2011 Physician Japan
Primary
Concomitant
Pulmonary Arterial Hypertension Hospitalization 2/24/2007 28 Female 5/26/2011 Physician Japan
Primary
Concomitant
Pulmonary Arterial Hypertension Death Male 139 lb 5/26/2011 Physician Japan
Primary
Concomitant
Cardiac Failure Death 5/20/2008 68 Female 88 lb 5/31/2011 Physician Japan
Primary
Concomitant
Concomitant Disease Aggravated Other Serious 2/16/2010 81 Female 95 lb 6/1/2011 Physician Japan
Primary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 3/9/2011 81 Male 121 lb 6/2/2011 Physician Japan
Primary
Concomitant
Dyspnoea Hospitalization 11/30/2010 66 Female 176 lb 6/3/2011 Physician New Zealand
Primary
Secondary
Concomitant
Candidiasis Death 4/20/2010 59 Female 6/8/2011 Physician Japan
Primary
Concomitant
Gamma-glutamyltransferase Increased Hospitalization 2/25/2010 75 Male 141 lb 6/29/2011 Physician Japan
Primary
Concomitant
Condition Aggravated Death 6/14/2011 32 Female 6/29/2011 Physician Japan
Primary
Concomitant
Parenteral Nutrition Hospitalization 10/16/2009 50 Female 88 lb 7/5/2011 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 8/23/2010 92 Female 7/8/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 6/21/2007 63 Male 139 lb 7/27/2011 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 8/23/2010 53 Female 115 lb 7/19/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Death 3/9/2011 81 Male 121 lb 8/9/2011 Physician Japan
Primary
Concomitant
Vomiting Death 7/6/2011 53 Female 8/10/2011 Pharmacist Japan
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Death 12/28/2010 83 Female 99 lb 8/26/2011 Physician Japan
Primary
Concomitant
Chills Hospitalization 2/15/2007 28 Female 9/6/2011 Physician Japan
Primary
Concomitant
Renal Impairment Death 8/6/2008 40 Female 9/6/2011 Physician Japan
Primary
Secondary
Concomitant
Jaundice Hospitalization 1/1/2011 51 Female 187 lb 9/15/2011 Physician Germany
Primary
Secondary
Concomitant
Biliary Cirrhosis Primary Hospitalization 5/28/2009 55 Female 128 lb 10/7/2011 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 2/25/2010 75 Male 141 lb 10/19/2011 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 12/28/2010 83 Female 99 lb 10/21/2011 Physician Japan
Primary
Concomitant
Alanine Aminotransferase Increased Hospitalization 5/21/2007 49 Female 132 lb 11/3/2011 Physician Japan
Primary
Concomitant
Rash Pustular Other Serious 76 Female 165 lb 11/15/2011 Physician France
Primary
Secondary
Concomitant
Bronchitis Hospitalization 10/16/2006 48 Female 132 lb 11/23/2011 Physician Japan
Primary
Concomitant
Chest Pain Death 11/12/2010 71 Male 117 lb 12/2/2011 Physician Japan
Primary
Concomitant
General Physical Health Deterioration Death 1/1/2011 75 Female 110 lb 12/5/2011 Physician Austria
Primary
Concomitant
No Therapeutic Response Disability 1/1/2009 78 Female 154 lb 12/13/2011 Other Health Professional Denmark
Primary
Concomitant
Endotracheal Intubation Hospitalization 48 Female 12/13/2011 Physician Germany
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 5/26/2010 73 Female 128 lb 12/16/2011 Physician Japan
Primary
Concomitant
Scleroderma Death 8/1/2011 76 Female 187 lb 12/19/2011 Physician Australia
Primary
Concomitant
Concomitant Disease Aggravated Death 11/12/2010 71 Male 117 lb 12/22/2011 Physician Japan
Primary
Concomitant
Syncope Other Serious 1/1/2011 73 Female 165 lb 12/29/2011 Physician Germany
Primary
Concomitant
Joint Swelling Other Serious 11/11/2010 36 Female 187 lb 1/23/2012 Physician Austria
Primary
Concomitant
Cardiac Failure Hospitalization 2/25/2010 75 Male 141 lb 1/23/2012 Physician Japan
Primary
Secondary
Concomitant
No Therapeutic Response Hospitalization 1/1/2009 78 Female 154 lb 1/25/2012 Other Health Professional Denmark
Primary
Concomitant

Drug Data