Sandimmune combined with Simulect

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Swelling Face Other Serious 1/3/2006 65 Male 154 lb 1/21/2006 Physician Belgium
Primary
Secondary
Concomitant
Agranulocytosis Other Serious 7/4/2005 18 Female 112 lb 1/26/2006 Physician Germany
Primary
Secondary
Concomitant
Swelling Face Other Serious 1/2/2006 66 Male 154 lb 2/3/2006 Physician Belgium
Primary
Secondary
Concomitant
Vascular Pseudoaneurysm Hospitalization 53 Female 152 lb 2/7/2006 Other Health Professional Spain
Primary
Secondary
Tuberculosis Hospitalization 56 Female 134 lb 2/7/2006 Other Health Professional Spain
Primary
Secondary
Swelling Face Other Serious 1/2/2006 66 Male 154 lb 3/11/2006 Physician Belgium
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 4/23/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 11/17/2004 46 Female 6/6/2006 Consumer Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 11/17/2004 46 Female 6/25/2006 Consumer Japan
Primary
Secondary
Concomitant
Neurotoxicity Other Serious 9/6/2005 3 Male 7/18/2006 Physician France
Primary
Secondary
Concomitant
Shock Life Threatening 6/15/2005 31 Female 132 lb 8/17/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 6/15/2005 31 Female 132 lb 9/5/2006 Physician Japan
Primary
Secondary
Concomitant
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
Urine Output Decreased Other Serious 11/4/2003 3 Male 26 lb 3/28/2007 Physician 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
Hepatitis Acute Other Serious 2/12/2006 29 Female 128 lb 6/14/2007 Physician Germany
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 6/15/2007 Physician Japan
Primary
Secondary
Concomitant
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 6/25/2007 Physician France
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 8/31/2007 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 10/11/2007 Physician Japan
Primary
Secondary
Concomitant
Small Intestine Ulcer Other Serious 11/14/2003 23 Male 112 lb 11/6/2007 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/15/2007 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/25/2007 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 11/29/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 10/16/2007 Female 12/19/2007 Pharmacist Japan
Primary
Secondary
Renal Impairment Other Serious 6/22/2006 48 Male 112 lb 2/9/2008 Japan
Primary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 2/12/2008 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 6/22/2006 48 Male 112 lb 2/13/2008 Japan
Primary
Concomitant
Renal Impairment Other Serious 6/22/2006 49 Male 112 lb 2/27/2008 Japan
Primary
Concomitant
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 4/12/2008 France
Primary
Secondary
Concomitant
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 4/30/2008 France
Primary
Secondary
Concomitant
Kidney Transplant Rejection Hospitalization 3/16/2007 47 Male 5/7/2008 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
Viral Infection Other Serious 4/22/2007 Male 152 lb 7/8/2008 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 3/14/2007 Male 7/21/2008 Physician Japan
Primary
Secondary
Concomitant
Syncope Hospitalization 6/27/2008 Male 7/28/2008 Physician Germany
Primary
Secondary
Concomitant
Vocal Cord Paralysis Hospitalization 2/22/2008 Male 139 lb 11/6/2008 Physician 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
Vocal Cord Paralysis Hospitalization 2/22/2008 Male 139 lb 11/26/2008 Physician Japan
Primary
Secondary
Concomitant
Syncope Hospitalization 6/27/2008 Male 12/2/2008 Physician Germany
Primary
Secondary
Concomitant
Abdominal Wound Dehiscence Hospitalization 7/2/2008 12/2/2008 Physician Germany
Primary
Secondary
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
Osteonecrosis Other Serious 11/4/2003 Male 12/29/2008 Physician
Primary
Secondary
Concomitant
Metabolic Acidosis Hospitalization Female 1/2/2009 Physician Germany
Primary
Secondary
Viral Infection Other Serious 4/22/2007 Male 152 lb 1/8/2009 Physician Japan
Primary
Secondary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 7 Female 38 lb 1/30/2009 Physician Japan
Primary
Concomitant
Metabolic Acidosis Hospitalization 11/26/2008 Female 2/16/2009 Physician Germany
Primary
Secondary
Osteonecrosis Other Serious 7/28/2003 Male 121 lb 2/24/2009 Physician Japan
Primary
Secondary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 7 Female 38 lb 2/25/2009 Physician 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
Urinary Tract Infection Other Serious 1/27/2009 Male 152 lb 4/8/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 6/9/2008 Male 179 lb 4/21/2009 Physician Germany
Primary
Secondary
Concomitant
Hypertension Other Serious 5/11/2007 Female 4/29/2009 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 5/11/2007 Female 4/29/2009 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 7/4/2008 Male 148 lb 5/1/2009 Physician Germany
Primary
Secondary
Viral Infection Other Serious 4/22/2007 Male 152 lb 5/14/2009 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 6/9/2008 Male 179 lb 5/22/2009 Physician Germany
Primary
Secondary
Concomitant
Vomiting Other Serious 5/10/2009 Female 5/28/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 11/18/2002 Male 139 lb 6/23/2009 Physician Japan
Primary
Secondary
Concomitant
Vocal Cord Paralysis Hospitalization 2/22/2008 Male 139 lb 7/3/2009 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 4/1/2008 41 Male 7/7/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Other Serious 1/24/2006 Male 95 lb 7/14/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 2/20/2009 Male 7/28/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 11/6/2008 Female 8/3/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 7/25/2006 Female 128 lb 8/17/2009 Physician Japan
Primary
Secondary
Concomitant
Intestinal Obstruction Other Serious 9/7/2008 Male 132 lb 8/24/2009 Other Health Professional Japan
Primary
Concomitant
Renal Failure Other Serious 2/20/2009 Male 130 lb 8/31/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 11/6/2008 Female 104 lb 9/2/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 9/24/2008 Male 154 lb 9/3/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 2/20/2009 Male 130 lb 10/5/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 2/5/2009 Female 146 lb 10/9/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 10/16/2009 Male 12/4/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 10/16/2009 Male 12/4/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 10/16/2007 Female 93 lb 12/23/2009 Physician Japan
Primary
Secondary
Concomitant
Proteinuria Hospitalization 11/1/2009 Male 106 lb 12/24/2009 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 5/11/2007 Female 12/28/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 10/13/2009 Male 12/28/2009 Physician Japan
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 1/7/2009 Male 1/27/2010 Physician Germany
Primary
Secondary
Urine Output Decreased Other Serious 10/13/2009 Male 1/29/2010 Physician Japan
Primary
Secondary
Concomitant
Cerebral Infarction Death 46 Male 2/2/2010 Physician Japan
Primary
Concomitant
Reperfusion Injury Life Threatening 10/22/2007 Female 93 lb 2/9/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 9/5/2008 Male 2/16/2010 Physician Germany
Primary
Secondary
Concomitant
Cerebral Infarction Death 46 Male 2/17/2010 Physician Japan
Primary
Concomitant
Renal Tubular Necrosis Other Serious 7/25/2006 Female 128 lb 2/24/2010 Physician Japan
Primary
Secondary
Concomitant
Leukopenia Hospitalization 11/1/2009 Female 370 lb 2/26/2010 Physician Germany
Primary
Secondary
Concomitant
Cerebral Infarction Death 46 Male 3/5/2010 Physician Japan
Primary
Concomitant
Hypertension Other Serious 5/11/2007 Female 3/16/2010 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 3/4/2010 Male 161 lb 3/19/2010 Physician Germany
Primary
Secondary
Death Death 3/13/2010 Male 3/22/2010 Physician Germany
Primary
Secondary
Concomitant
Tachycardia Hospitalization 2/11/2010 51 Female 144 lb 4/1/2010 Physician Germany
Primary
Secondary
Concomitant
Respiratory Failure Death 11/16/2009 69 Male 154 lb 4/1/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 7/25/2006 38 Female 128 lb 4/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 3/4/2010 66 Male 161 lb 4/7/2010 Physician Germany
Primary
Secondary
Pancytopenia Hospitalization 3/4/2010 66 Male 161 lb 4/7/2010 Physician Germany
Primary
Secondary
Urosepsis Hospitalization 3/4/2010 68 Female 4/20/2010 Physician Germany
Primary
Secondary
Confusional State Hospitalization 3/24/2010 65 Female 4/23/2010 Physician Germany
Primary
Secondary
Tachycardia Hospitalization 2/11/2010 51 Female 144 lb 4/30/2010 Physician Germany
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 12/8/2008 33 Male 174 lb 5/4/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 9/5/2008 55 Male 5/7/2010 Physician Germany
Primary
Secondary
Concomitant
Surgery Hospitalization 3/14/2007 48 Male 5/17/2010 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Death 3/13/2010 65 Male 5/28/2010 Physician Germany
Primary
Secondary
Concomitant
Vascular Graft Other Serious 5/10/2010 60 Male 311 lb 6/7/2010 Physician Germany
Primary
Concomitant
Respiratory Failure Death 11/16/2009 69 Male 154 lb 6/7/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Surgery Hospitalization 3/14/2007 48 Male 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Vascular Graft Hospitalization 4/26/2010 59 Male 311 lb 6/18/2010 Physician Germany
Primary
Secondary
Concomitant
Visual Impairment Other Serious 3/1/2010 35 Female 6/22/2010 Physician Japan
Primary
Secondary
Concomitant
Interacting
Renal Failure Hospitalization Female 174 lb 6/22/2010 Physician Germany
Primary
Secondary
Renal Failure Hospitalization 10/8/2007 55 Male 162 lb 6/23/2010 Physician Germany
Primary
Secondary
Upper Respiratory Tract Infection Hospitalization 10/29/2008 68 Male 148 lb 6/25/2010 Physician Germany
Primary
Secondary
Upper Respiratory Tract Infection Hospitalization 10/29/2008 68 Male 148 lb 6/30/2010 Physician Germany
Primary
Secondary
Glycosylated Haemoglobin Increased Hospitalization Female 214 lb 7/2/2010 Physician Germany
Primary
Secondary
Vascular Graft Hospitalization 4/26/2010 59 Male 311 lb 7/2/2010 Physician Germany
Primary
Secondary
Concomitant
Carbohydrate Antigen 125 Increased Hospitalization 4/26/2010 59 Female 212 lb 7/13/2010 Physician Germany
Primary
Secondary
Proteinuria Hospitalization 11/1/2009 67 Male 106 lb 7/13/2010 Physician Japan
Primary
Secondary
Concomitant
Carbohydrate Antigen 125 Increased Hospitalization 4/26/2010 59 Female 212 lb 7/20/2010 Physician Germany
Primary
Secondary
Urinary Tract Infection Other Serious 18 Male 100 lb 7/29/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Hospitalization 12/7/2007 52 Female 174 lb 7/30/2010 Physician Germany
Primary
Secondary
Carbohydrate Antigen 125 Increased Hospitalization 4/26/2010 59 Female 212 lb 8/5/2010 Physician Germany
Primary
Secondary
Glycosylated Haemoglobin Increased Hospitalization Female 214 lb 8/4/2010 Physician Germany
Primary
Secondary
Vascular Graft Hospitalization 4/26/2010 59 Male 311 lb 8/17/2010 Physician Germany
Primary
Secondary
Concomitant
Visual Impairment Other Serious 3/1/2010 35 Female 8/20/2010 Physician Japan
Primary
Secondary
Concomitant
Interacting
Gastrointestinal Haemorrhage Hospitalization 10/14/2009 44 Male 203 lb 9/17/2010 Physician Japan
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 10/25/2006 54 Male 9/23/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Incontinence Hospitalization 5/11/2010 69 Male 194 lb 9/23/2010 Physician Germany
Primary
Secondary
Concomitant
Polypectomy Hospitalization 9/28/2010 63 Male 123 lb 10/7/2010 Physician Japan
Primary
Secondary
Concomitant
Death Death 11/15/2009 65 Female 119 lb 10/11/2010 Physician Japan
Primary
Concomitant
Hydrocele Operation Hospitalization 1/5/2010 50 Male 10/25/2010 Physician Switzerland
Primary
Secondary
Concomitant
Polypectomy Hospitalization 9/27/2010 63 Male 123 lb 10/26/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/13/2010 51 Female 154 lb 10/27/2010 Physician Germany
Primary
Secondary
Renal Failure Other Serious 11/9/2007 55 Male 162 lb 11/2/2010 Physician Germany
Primary
Secondary
Hepatitis C Other Serious 6/25/2008 68 Male 163 lb 11/4/2010 Physician Germany
Primary
Secondary
Concomitant
Seroma Hospitalization 8/15/2010 67 Male 11/9/2010 Physician Germany
Primary
Secondary
Concomitant
Shock Hospitalization 10/1/2010 11/10/2010 Physician Japan
Primary
Secondary
Hepatitis C Other Serious 6/25/2008 68 Male 163 lb 11/22/2010 Physician Germany
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/13/2010 65 Male 11/23/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/25/2010 71 Female 11/25/2010 Physician Germany
Primary
Secondary
Concomitant
Pyrexia Hospitalization 10/25/2010 71 Female 11/25/2010 Physician Germany
Primary
Secondary
Concomitant
Surgery Other Serious 9/11/2009 68 Female 11/29/2010 Physician Japan
Primary
Secondary
Concomitant
Death Other Serious 12/15/2009 65 Female 119 lb 12/10/2010 Physician Japan
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 12/22/2008 40 Female 159 lb 12/13/2010 Physician Japan
Primary
Secondary
Concomitant
Proteinuria Hospitalization 11/1/2009 67 Male 106 lb 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Other Serious 10/14/2009 44 Male 203 lb 12/20/2010 Physician Japan
Primary
Secondary
Concomitant

Drug Data