Neoral combined with Sandimmune

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Eye Oedema Other Serious Male 1/4/2006 Pharmacist Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 10/1/2005 58 Male 3/4/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 2/27/2006 50 Male 3/11/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 2/27/2006 50 Male 3/21/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 7/1/2005 14 Male 3/21/2006 Japan
Primary
Secondary
Pancytopenia Hospitalization 1/28/2002 30 Male 3/29/2006 Physician Japan
Primary
Secondary
Concomitant
Trichosporon Infection Other Serious 1/1/2004 30 Male 3/29/2006 Japan
Primary
Secondary
Concomitant
Toxic Induced Encephalopathy Hospitalization 10/1/2005 58 Male 3/30/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 7/16/2005 21 Male 88 lb 4/3/2006 Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 11/26/2004 45 Male 161 lb 4/4/2006 Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/11/2005 12 Female 4/10/2006 Japan
Primary
Secondary
Toxic Induced Encephalopathy Hospitalization 8/28/2005 58 Male 4/13/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 8/11/2005 12 Female 4/19/2006 Japan
Primary
Secondary
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 4/23/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 2/27/2006 50 Male 4/25/2006 Physician Japan
Primary
Secondary
Concomitant
Myositis Hospitalization 12/7/2001 10 Male 4/28/2006 Physician Japan
Primary
Secondary
Concomitant
Toxic Induced Encephalopathy Hospitalization 8/28/2005 58 Male 4/29/2006 Physician Japan
Primary
Secondary
Concomitant
Mental Disorder Death 4/10/2006 52 Female 84 lb 5/9/2006 Physician Japan
Primary
Secondary
Concomitant
Mental Disorder Death 4/10/2006 52 Female 84 lb 5/9/2006 Physician Japan
Primary
Secondary
Concomitant
Myelitis Hospitalization 12/7/2001 7 Male 5/17/2006 Physician Japan
Primary
Secondary
Concomitant
Toxic Induced Encephalopathy Hospitalization 8/28/2005 58 Male 5/20/2006 Physician Japan
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 8/1/2001 67 Male 5/19/2006 Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 11/26/2004 45 Male 161 lb 5/31/2006 Japan
Primary
Secondary
Concomitant
Mental Disorder Death 4/10/2006 52 Female 84 lb 5/31/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 8/1/2001 67 Male 5/31/2006 Japan
Primary
Secondary
Concomitant
Toxic Induced Encephalopathy Hospitalization 8/28/2005 58 Male 6/5/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 11/17/2004 46 Female 6/6/2006 Consumer Japan
Primary
Secondary
Concomitant
Pain In Extremity Hospitalization 9/28/2005 42 Female 6/26/2006 Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 11/17/2004 46 Female 6/25/2006 Consumer Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 8/1/2001 67 Male 7/7/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 9/6/2005 3 Male 7/18/2006 Physician France
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 3/1/2006 44 Male 7/18/2006 France
Primary
Secondary
White Blood Cell Count Increased Other Serious 8/1/2001 67 Male 7/28/2006 Other Health Professional Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 8/28/2005 58 Male 119 lb 8/1/2006 Physician Japan
Primary
Secondary
Thrombosis Disability 8/28/2005 58 Male 9/1/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombosis Disability 8/28/2005 58 Male 9/15/2006 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 68 Female 99 lb 10/7/2006 Japan
Primary
Secondary
Respiratory Failure Other Serious 68 Female 99 lb 10/17/2006 Japan
Primary
Secondary
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 10/24/2006 Physician Japan
Primary
Secondary
Concomitant
Surgery Hospitalization 11/1/2005 29 Male 11/4/2006 Japan
Primary
Secondary
Concomitant
Surgery Hospitalization 9/21/2006 51 Female 86 lb 11/4/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 3/15/2005 22 Male 11/27/2006 Japan
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 12/25/2006 Pharmacist United Kingdom
Primary
Secondary
Surgery Life Threatening 9/21/2006 51 Female 86 lb 1/2/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombophlebitis Other Serious 1/1/2003 34 Female 1/5/2007 Japan
Primary
Secondary
Concomitant
Surgery Life Threatening 9/21/2006 51 Female 86 lb 2/13/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 86 lb 2/23/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Pustular Other Serious 57 Female 3/3/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Rash Other Serious 4/25/2003 46 Male 128 lb 3/5/2007 Japan
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 12/17/2006 33 Male 3/9/2007 Physician France
Primary
Secondary
Rash Other Serious 4/25/2003 46 Male 128 lb 4/3/2007 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 5/15/2006 40 Male 128 lb 4/3/2007 Physician Japan
Primary
Secondary
Concomitant
Malabsorption Other Serious 9/21/2006 32 Female 172 lb 4/6/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/1/2003 13 Male 6/13/2007 Japan
Primary
Secondary
Urine Output Decreased Other Serious 5/21/2007 56 Male 6/15/2007 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Death 57 Male 6/19/2007 Japan
Primary
Secondary
Gastric Cancer Death 57 Male 6/19/2007 Japan
Primary
Secondary
Gastric Cancer Death 57 Male 6/21/2007 Japan
Primary
Secondary
Tracheostomy Other Serious 5/2/2007 32 Male 6/21/2007 Physician Germany
Primary
Secondary
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 6/25/2007 Physician France
Primary
Secondary
Concomitant
Tracheostomy Other Serious 5/2/2007 32 Male 6/30/2007 Physician Germany
Primary
Secondary
Therapeutic Response Decreased Other Serious 12/1/2001 15 Male 137 lb 7/13/2007 Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 12/1/2001 15 Male 137 lb 7/16/2007 Japan
Primary
Secondary
Concomitant
Neutrophilia Other Serious 8/23/2000 11 Male 60 lb 7/18/2007 Japan
Primary
Secondary
Concomitant
Neutrophilia Other Serious 8/23/2000 11 Male 60 lb 7/18/2007 Japan
Primary
Secondary
Concomitant
Tubulointerstitial Nephritis Other Serious 8/1/2005 11 Male 8/17/2007 Japan
Primary
Secondary
Tubulointerstitial Nephritis Other Serious 8/1/2005 11 Male 8/17/2007 Japan
Primary
Secondary
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 8/31/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Disorder Other Serious 11/15/2005 54 Male 121 lb 10/4/2007 Japan
Primary
Concomitant
Skin Lesion Death 10/10/1996 60 Male 10/6/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Malaise Life Threatening Male 10/9/2007 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 11/15/2005 54 Male 121 lb 10/16/2007 Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 7/3/2003 1 Male 19 lb 10/17/2007 Japan
Primary
Secondary
Concomitant
Skin Disorder Other Serious 11/15/2005 54 Male 121 lb 10/18/2007 Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 5/14/2007 25 Female 115 lb 10/30/2007 Physician Japan
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 9/1/2007 14 Female 11/2/2007 Physician Japan
Primary
Secondary
Concomitant
Respiratory Arrest Life Threatening 9/21/2006 51 Female 11/9/2007 Physician Germany
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/15/2007 Japan
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Hospitalization 1/1/2007 73 Male 11/24/2007 Japan
Primary
Secondary
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/25/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/18/2007 1 Female 11 lb 12/4/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 6/18/2007 1 Female 11 lb 12/20/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 12/1/2001 15 Male 137 lb 1/22/2008 Japan
Primary
Secondary
Concomitant
Nausea Other Serious 9/26/2007 59 Male 121 lb 2/6/2008 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 2/12/2008 Japan
Primary
Secondary
Concomitant
Rash Other Serious 12/1/2006 56 Male 3/11/2008 Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 11 Male 4/9/2008 Japan
Primary
Concomitant
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 4/12/2008 France
Primary
Secondary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/17/2008 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 9/28/2005 42 Female 4/19/2008 Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/22/2008 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 1/1/2007 11 Male 4/25/2008 Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 1/12/2008 45 Male 4/29/2008 France
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 1/12/2008 45 Male 4/29/2008 France
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 1/12/2008 45 Male 4/29/2008 France
Primary
Secondary
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 4/30/2008 France
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 23 Male 123 lb 5/21/2008 Physician Japan
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 23 Male 123 lb 5/22/2008 Physician Japan
Primary
Secondary
Concomitant
Vascular Calcification Hospitalization 12/21/2004 Female 5/30/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 5/30/2008 Physician Japan
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 5/30/2008 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 3/10/2008 Male 181 lb 5/30/2008 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 3/10/2008 Male 181 lb 6/5/2008 Physician Japan
Primary
Secondary
Concomitant
Low Density Lipoprotein Increased Hospitalization 6/22/2007 Female 6/20/2008 Physician Japan
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 6/24/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 7/8/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 7/15/2008 Physician Japan
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 3/14/2007 Male 7/21/2008 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 1/1/1995 32 Male 7/31/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 1/1/1995 32 Male 7/31/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 9/26/1999 Female 136 lb 7/22/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Percutaneous Coronary Intervention Other Serious 1/1/1995 32 Male 8/8/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 3/1/1995 Male 277 lb 9/2/2008 Physician United States
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 9/7/1995 Male 206 lb 9/2/2008 Physician United States
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 10/19/1994 Male 169 lb 9/4/2008 Physician United States
Primary
Secondary
Concomitant
Intestinal Ulcer Perforation Hospitalization 7/3/1997 Female 9/4/2008 Physician United States
Primary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Hospitalization 6/23/1999 Male 139 lb 9/16/2008 Physician United States
Primary
Secondary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 Physician Japan
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 10/1/2008 Physician Japan
Primary
Secondary
Concomitant
Melaena Other Serious 10/16/2008 60 Male 11/4/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Vocal Cord Paralysis Hospitalization 2/22/2008 Male 139 lb 11/6/2008 Physician Japan
Primary
Secondary
Concomitant
Melaena Other Serious 10/16/2008 60 Male 11/6/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 11/14/2008 Physician Japan
Primary
Secondary
Concomitant
Low Density Lipoprotein Increased Hospitalization 6/22/2007 Female 11/25/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 46 Male 11/25/2008 Physician Japan
Primary
Secondary
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 3/1/2006 13 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Vocal Cord Paralysis Hospitalization 2/22/2008 Male 139 lb 11/26/2008 Physician Japan
Primary
Secondary
Concomitant
Percutaneous Coronary Intervention Other Serious 1/1/1995 32 Male 12/10/2008 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 12/20/2006 Male 174 lb 12/17/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 12/20/2006 Male 174 lb 12/17/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 12/23/2008 Physician Japan
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 11/4/2003 Male 12/29/2008 Physician
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 1/8/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 1/16/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 1/1/1997 56 Male 2/20/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Residual Urine Hospitalization 4/9/2008 Male 123 lb 2/20/2009 Physician Japan
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 7/28/2003 Male 121 lb 2/24/2009 Physician Japan
Primary
Secondary
Concomitant
Varicella Other Serious 1/1/2003 21 Male 2/27/2009 Other Health Professional Japan
Primary
Concomitant
Varicella Other Serious 1/1/2003 21 Male 2/27/2009 Other Health Professional Japan
Primary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 3/3/2009 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 5/11/2007 Female 3/24/2009 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 1/27/2009 Male 152 lb 3/30/2009 Physician Japan
Primary
Secondary
Concomitant