Prograf combined with Urso 250

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Microangiopathy Life Threatening 3/25/2004 52 Female 93 lb 5/22/2006 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/20/2005 9 Female 86 lb 6/30/2006 Physician Japan
Primary
Concomitant
Shock Death 7/19/2006 82 Female 8/25/2006 Physician Japan
Primary
Concomitant
Vulvovaginal Discomfort Other Serious 3/8/2006 54 Female 103 lb 9/19/2006 Physician Japan
Primary
Secondary
Concomitant
Lactic Acidosis Death 1/1/2005 23 Male 187 lb 10/16/2006 Physician Japan
Primary
Concomitant
Vulvovaginal Discomfort Other Serious 3/8/2006 54 Female 103 lb 11/7/2006 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 5/16/2006 18 Male 11/21/2006 Japan
Primary
Secondary
Concomitant
Vulvovaginal Discomfort Other Serious 3/8/2006 54 Female 103 lb 2/1/2007 Physician Japan
Primary
Secondary
Concomitant
Shock Hospitalization 6/2/2006 82 Female 2/20/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 7/7/2004 54 Male 117 lb 5/15/2007 Physician Japan
Primary
Secondary
Concomitant
Delirium Other Serious 4/2/2007 22 Male 5/22/2007 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/20/2005 59 Male 143 lb 7/13/2007 Physician Japan
Primary
Concomitant
Somnolence Other Serious 7/6/2000 52 Male 110 lb 9/12/2007 Physician Japan
Primary
Concomitant
Immunosuppressant Drug Level Decreased Other Serious 7/6/2000 52 Male 110 lb 9/21/2007 Physician Japan
Primary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 10/18/2007 Consumer United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/9/2007 Physician Japan
Primary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 12/7/2007 Consumer United States
Primary
Secondary
Concomitant
Nephrotic Syndrome Disability 5/1/2007 59 Male 135 lb 12/20/2007 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 3/12/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/17/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/22/2008 Physician Japan
Primary
Concomitant
Tremor Life Threatening 3/21/2008 53 Female 146 lb 4/16/2008 Physician Poland
Primary
Concomitant
Nail Disorder Hospitalization 4/1/2001 Male 4/16/2008 Physician Japan
Primary
Concomitant
Tremor Required Intervention 3/21/2008 53 Female 146 lb 5/5/2008 Physician Poland
Primary
Concomitant
Respiratory Failure Other Serious 4/11/2008 Female 43 lb 5/19/2008 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 3/21/2005 31 Female 106 lb 5/22/2008 Physician Japan
Primary
Concomitant
Tremor Life Threatening 3/1/2008 53 Female 146 lb 5/30/2008 Physician Poland
Primary
Concomitant
Respiratory Failure Other Serious 4/11/2008 Female 43 lb 6/10/2008 Japan
Primary
Secondary
Concomitant
Wrist Fracture Hospitalization 6/5/2005 Female 6/13/2008 Consumer United States
Primary
Concomitant
Weight Increased Other Serious 1/1/2007 Male 6/13/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/11/2008 Female 43 lb 6/17/2008 Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/11/2008 Female 43 lb 6/27/2008 Japan
Primary
Secondary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 12/5/2003 Male 6/30/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 4/11/2008 9 Female 6/25/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 2/1/2008 Male 6/30/2008 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/11/2008 9 Female 7/1/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 7/11/2008 Physician Japan
Primary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 7/15/2008 Physician Japan
Primary
Concomitant
Pericardial Effusion Life Threatening 6/21/2008 1 Female 8 lb 7/10/2008 Physician Japan
Primary
Concomitant
Dehydration Other Serious 1/1/2008 53 Male 7/14/2008 Consumer United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 7/29/2008 Physician Japan
Primary
Concomitant
Altered State Of Consciousness Life Threatening 4/17/2008 59 Male 7/31/2008 Physician Japan
Primary
Secondary
Concomitant
Insomnia Hospitalization 6/5/2008 59 Male 146 lb 8/20/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 8/25/2008 Physician Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Other Serious 9/12/2004 9 Male 119 lb 8/22/2008 Physician Japan
Primary
Concomitant
Fluid Intake Reduced Other Serious 1/1/2008 53 Male 8/29/2008 United States
Primary
Secondary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 7/16/2008 38 Male 130 lb 9/26/2008 Physician Japan
Primary
Concomitant
Wrist Fracture Hospitalization 6/5/2005 Female 10/3/2008 Lawyer United States
Primary
Concomitant
Wrist Fracture Hospitalization 6/5/2005 Female 120 lb 10/8/2008 Lawyer United States
Primary
Concomitant
Wrist Fracture Hospitalization 6/5/2005 Female 120 lb 10/10/2008 Lawyer United States
Primary
Concomitant
Vomiting Other Serious 4/21/2007 69 Female 82 lb 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 11/4/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 9/21/2006 Male 123 lb 11/24/2008 Physician Japan
Primary
Concomitant
Diabetes Mellitus Hospitalization 2/6/2008 Female 12/1/2008 Physician
Primary
Secondary
Concomitant
Diabetes Mellitus Hospitalization 2/9/2008 54 Female 12/3/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/5/2008 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/1/2008 7 Female 12/23/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Other Serious 12/27/2007 Female 44 lb 12/24/2008 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Life Threatening 8/6/2007 23 Female 121 lb 1/9/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 7/7/2007 Female 249 lb 2/2/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Oedema Life Threatening 12/1/2008 7 Female 1/30/2009 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 7/16/2008 38 Male 130 lb 2/9/2009 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 4/18/2008 Female 43 lb 2/11/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/16/2008 51 Male 97 lb 2/13/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 10/3/2008 60 Female 106 lb 3/12/2009 Physician Japan
Primary
Concomitant
Vomiting Other Serious 8/20/2008 45 Male 128 lb 3/12/2009 Physician Japan
Primary
Secondary
Concomitant
Nausea Life Threatening 9/28/2008 59 Female 123 lb 3/16/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 8/27/2008 18 Male 104 lb 4/6/2009 Japan
Primary
Concomitant
Respiratory Failure Other Serious 4/18/2008 Female 43 lb 4/8/2009 Japan
Primary
Secondary
Concomitant
Wrist Fracture Hospitalization 6/5/2005 Female 120 lb 4/11/2009 Lawyer United States
Primary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 4/14/2009 Physician Japan
Primary
Concomitant
Death Death 9/13/2007 Female 4/14/2009 Physician Japan
Primary
Concomitant
Death Death 5/19/2006 Male 4/14/2009 Physician Japan
Primary
Concomitant
Death Death 7/16/2007 Female 4/14/2009 Physician Japan
Primary
Concomitant
Death Death 5/11/2007 Male 4/14/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/18/2008 10 Female 43 lb 4/17/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 12/1/2008 7 Female 4/28/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Wrist Fracture Hospitalization 6/5/2005 Female 120 lb 5/4/2009 Lawyer United States
Primary
Concomitant
White Blood Cell Count Decreased Death 3/30/2007 Female 120 lb 5/26/2009 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 5/11/2007 Male 119 lb 5/26/2009 Physician Japan
Primary
Secondary
Concomitant
Blood Bilirubin Increased Death 9/13/2007 Female 90 lb 5/26/2009 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 5/19/2006 Male 137 lb 5/26/2009 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 7/16/2007 Female 88 lb 5/26/2009 Physician Japan
Primary
Concomitant
Viral Infection Other Serious 4/18/2008 10 Female 43 lb 5/28/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/16/2009 53 Male 112 lb 5/28/2009 Japan
Primary
Concomitant
Respiratory Failure Other Serious 4/18/2008 10 Female 43 lb 6/1/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 8/1/2008 6 Male 42 lb 6/5/2009 Japan
Primary
Secondary
Concomitant
Overdose Hospitalization 4/9/2009 62 6/5/2009 Japan
Primary
Concomitant
Renal Impairment Life Threatening 8/27/2008 18 Male 104 lb 6/22/2009 Japan
Primary
Concomitant
Shock Life Threatening 6/2/2009 65 Male 7/29/2009 Other Health Professional Japan
Primary
Concomitant
Stomatitis Death 3/12/2008 Male 126 lb 7/31/2009 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/23/2008 59 Female 123 lb 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 8/12/2009 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 8/4/2008 6 Male 42 lb 8/28/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 9/3/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 6/26/2008 57 Male 137 lb 9/8/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 6/8/2009 49 Male 121 lb 9/10/2009 Physician Japan
Primary
Concomitant
Stomatitis Life Threatening 9/28/2008 59 Female 123 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Life Threatening 4/14/2009 Female 9/16/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 6/8/2009 49 Male 121 lb 9/16/2009 Physician Japan
Primary
Concomitant
Renal Failure Other Serious 6/8/2009 49 Male 121 lb 9/25/2009 Physician Japan
Primary
Concomitant
Pseudomembranous Colitis Other Serious 8/25/2008 18 Male 128 lb 10/1/2009 Physician Japan
Primary
Secondary
Concomitant
Fanconi Syndrome Hospitalization 1/1/2005 Male 10/9/2009 Physician Japan
Primary
Secondary
Concomitant
Fanconi Syndrome Hospitalization 10/1/2008 Female 10/9/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 8/8/2008 51 Male 97 lb 10/14/2009 Physician Japan
Primary
Secondary
Concomitant
Fanconi Syndrome Hospitalization 10/1/2008 Female 10/16/2009 Physician Japan
Primary
Secondary
Concomitant
Metabolic Acidosis Hospitalization 1/1/2005 Male 10/16/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 6/8/2009 49 Male 121 lb 10/19/2009 Physician Japan
Primary
Concomitant
Urine Uric Acid Increased Hospitalization 10/1/2005 Female 11/9/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Uric Acid Increased Hospitalization 10/1/2005 Female 11/11/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 4/14/2009 Female 11/12/2009 Physician Japan
Primary
Concomitant
Drug Interaction Hospitalization 1/8/2009 62 Female 117 lb 2/1/2010 Physician Japan
Primary
Concomitant
Interacting
Pneumonia Life Threatening 11/16/2008 Male 165 lb 2/3/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/2/2009 62 Female 2/17/2010 Physician Japan
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 1/8/2009 62 Female 117 lb 2/17/2010 Physician Japan
Primary
Concomitant
Interacting
Stomatitis Death 3/12/2008 Male 126 lb 3/9/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/13/2009 41 Male 119 lb 3/9/2010 Physician Japan
Primary
Concomitant
Gait Disturbance Other Serious 11/1/2009 84 Male 3/15/2010 Physician Japan
Primary
Secondary
Concomitant
Organising Pneumonia Hospitalization 4/16/2009 Male 3/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 2/2/2009 63 Male 143 lb 4/6/2010 Physician Japan
Primary
Concomitant
Pancreatitis Acute Other Serious 3/10/2010 13 Female 88 lb 4/23/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Life Threatening 11/14/2008 60 Male 165 lb 4/26/2010 Physician Japan
Primary
Concomitant
Pancreatitis Acute Other Serious 3/10/2010 13 Female 88 lb 5/6/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 2/2/2009 63 Male 143 lb 5/11/2010 Physician Japan
Primary
Concomitant
Refractoriness To Platelet Transfusion Other Serious 7/20/2008 2 Female 24 lb 5/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/2/2009 62 Female 5/27/2010 Physician Japan
Primary
Secondary
Concomitant
Wrist Fracture Other Serious 6/6/2005 62 Female 120 lb 6/8/2010 Physician United States
Primary
Concomitant
Vestibular Disorder Congenital Anomaly 11/1/2009 84 Male 6/11/2010 Physician Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 7/20/2008 2 Female 24 lb 6/15/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 3/13/2010 2 Male 24 lb 6/15/2010 Physician Japan
Primary
Concomitant
Wrist Fracture Other Serious 6/6/2005 62 Female 120 lb 6/23/2010 Physician United States
Primary
Concomitant
Unevaluable Event 8/13/2009 59 Male 6/28/2010 Japan
Primary
Secondary
Concomitant
Vestibular Disorder 11/1/2009 84 Male 6/28/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Atrophy Hospitalization 8/11/2009 59 Male 7/2/2010 Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 6/22/2010 55 Male 189 lb 8/10/2010 Other Health Professional United States
Primary
Concomitant
Pain In Extremity Other Serious 4/1/2010 70 Male 230 lb 8/18/2010 Other Health Professional United States
Primary
Concomitant
Diabetes Mellitus Disability 2/28/2004 Male 9/20/2010 United States
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 2/26/2010 56 Male 10/7/2010 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization 6/8/2009 49 Male 121 lb 10/8/2010 Physician Japan
Primary
Concomitant
Facial Spasm Other Serious 8/14/2010 61 Female 99 lb 10/11/2010 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 2/26/2010 56 Male 11/10/2010 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 11/8/2009 15 Male 157 lb 11/11/2010 Physician Japan
Primary
Secondary
Concomitant
Refractoriness To Platelet Transfusion Other Serious 7/20/2008 2 Female 24 lb 11/4/2010 Physician Japan
Primary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 11/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/20/2009 51 Female 11/17/2010 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 3/4/2010 19 Male 12/3/2010 Other Health Professional Japan
Primary
Concomitant
Shock Life Threatening 11/11/2007 12 Female 80 lb 12/6/2010 Physician Japan
Primary
Secondary
Concomitant

Drug Data