Cellcept combined with Simulect

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Tremor Life Threatening 11/22/2004 31 Female 12/30/2005 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Oedema Death 1/31/2004 18 Female 97 lb 1/14/2006 Physician France
Primary
Concomitant
Polymorphonuclear Chromatin Clumping Other Serious 5/20/2004 47 Male 119 lb 1/17/2006 Physician Japan
Primary
Concomitant
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
Pyelonephritis Hospitalization 7/15/2002 37 Female 97 lb 1/24/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/1/2006 54 Female 2/6/2006 Physician Japan
Primary
Secondary
Concomitant
Swelling Face Other Serious 1/2/2006 66 Male 154 lb 2/3/2006 Physician Belgium
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/1/2006 54 Female 2/17/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/1/2006 54 Female 2/28/2006 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Uraemic Syndrome Other Serious 56 Male 3/10/2006 Japan
Primary
Concomitant
Swelling Face Other Serious 1/2/2006 66 Male 154 lb 3/11/2006 Physician Belgium
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 56 Male 3/17/2006 Japan
Primary
Secondary
Concomitant
Vanillyl Mandelic Acid Urine Increased Hospitalization 12/1/2003 61 Male 3/20/2006 Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 4/23/2006 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 49 Male 4/27/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Death 11/9/2003 15 Female 117 lb 4/27/2006 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Disability 11/14/2003 23 Male 115 lb 4/27/2006 Physician Japan
Primary
Secondary
Pyelonephritis Hospitalization 7/15/2002 37 Female 97 lb 4/25/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 7/3/2005 40 Female 143 lb 5/8/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 10/23/2003 15 Female 68 lb 5/23/2006 Physician Germany
Primary
Secondary
Graft Thrombosis Life Threatening 11/19/2003 63 Male 157 lb 5/12/2006 Physician Japan
Primary
Secondary
Concomitant
Acute Myocardial Infarction Death 2/22/2003 52 Male 6/5/2006 Physician Japan
Primary
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
Pyelonephritis Hospitalization 7/15/2002 37 Female 97 lb 6/15/2006 Physician Japan
Primary
Secondary
Concomitant
Somnolence Hospitalization 2/4/2005 9 Male 7/2/2006 Physician Germany
Primary
Secondary
Staphylococcal Sepsis Disability 11/14/2003 23 Male 115 lb 7/10/2006 Physician Japan
Primary
Secondary
Liver Function Test Abnormal Other Serious 7/3/2005 40 Female 143 lb 7/12/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Vein Thrombosis Hospitalization 9/1/2005 68 Female 5/5/2006 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 9/26/2005 54 Female 190 lb 5/5/2006 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 1/9/2006 45 Male 145 lb 5/5/2006 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 12/20/2005 49 Female 5/5/2006 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 2/7/2006 54 Female 148 lb 5/5/2006 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 11/3/2005 69 Male 208 lb 5/5/2006 Other Health Professional United States
Primary
Concomitant
Pseudomonas Infection Hospitalization 5/21/2006 65 Male 185 lb 7/24/2006 United States
Primary
Secondary
Concomitant
Renal Infarct Other Serious 4/11/2006 48 Female 8/4/2006 United States
Primary
Secondary
Concomitant
Epididymitis Hospitalization 3/15/2003 38 Male 121 lb 8/12/2006 Physician Japan
Primary
Secondary
Suture Related Complication Other Serious 7/3/2005 40 Female 143 lb 8/11/2006 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Staphylococcal Other Serious 5/9/2006 52 Male 8/8/2006 Spain
Primary
Concomitant
Shock Life Threatening 6/15/2005 31 Female 132 lb 8/17/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 5/21/2006 65 Male 185 lb 8/23/2006 Physician United States
Primary
Secondary
Concomitant
Vomiting Life Threatening 6/15/2005 31 Female 132 lb 9/5/2006 Physician Japan
Primary
Secondary
Concomitant
T-cell Lymphoma Death 12/1/2005 Male 173 lb 8/25/2006 Physician Japan
Primary
Secondary
Concomitant
Transplant Failure Death 12/1/2005 52 Male 173 lb 9/5/2006 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 4/17/2005 60 Male 9/14/2006 Physician Japan
Primary
Secondary
Renal Infarct Other Serious 4/10/2006 48 Female 9/15/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Jugular Vein Thrombosis Other Serious 4/9/2006 62 Female 138 lb 9/18/2006 United States
Primary
Concomitant
Renal Tubular Disorder Other Serious 4/1/2004 44 Female 9/29/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/20/2004 33 Male 146 lb 10/4/2006 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 12/20/2004 32 Female 73 lb 10/3/2006 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 12/20/2004 32 Female 73 lb 10/6/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 6/20/2006 74 Female 88 lb 10/9/2006 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 6/20/2006 74 Female 88 lb 10/19/2006 Physician Japan
Primary
Secondary
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 10/24/2006 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/1/2006 38 Male 161 lb 11/21/2006 Japan
Primary
Secondary
Concomitant
Splenectomy Hospitalization 3/1/2005 Female 115 lb 11/6/2006 Physician Japan
Primary
Concomitant
Respiration Abnormal Other Serious 11/8/2006 Male 64 lb 12/28/2006 Physician Japan
Primary
Secondary
Concomitant
Tremor Other Serious 6/28/2004 25 Male 66 lb 12/29/2006 Japan
Primary
Secondary
Concomitant
Mechanical Ileus Other Serious 11 Male 1/2/2007 Physician Japan
Primary
Concomitant
Hyperamylasaemia Other Serious 5/28/2006 39 Male 12/19/2006 Physician Japan
Primary
Secondary
Concomitant
Thyroidectomy Other Serious 2/1/2006 26 Female 1/5/2007 Japan
Primary
Secondary
Hyperamylasaemia Other Serious 5/28/2006 39 Male 12/29/2006 Physician Japan
Primary
Secondary
Concomitant
Leukoencephalopathy Other Serious 7/3/2004 26 Male 66 lb 12/29/2006 Physician Japan
Primary
Concomitant
Tremor Other Serious 6/28/2004 25 Male 66 lb 1/18/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 9/22/2004 69 Male 1/16/2007 Spain
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/3/2007 50 Male 1/12/2007 Pharmacist United States
Primary
Concomitant
White Blood Cell Count Increased Other Serious 7/1/2005 46 Male 1/31/2007 United States
Primary
Secondary
Concomitant
Sense Of Oppression Other Serious 11/8/2006 Male 64 lb 2/2/2007 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Other Serious 59 Female 2/13/2007 Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 11 Male 2/23/2007 Physician Ireland
Primary
Secondary
Malaise Other Serious 59 Female 2/23/2007 Japan
Primary
Secondary
Concomitant
Immune System Disorder Hospitalization 59 Female 2/9/2007 Physician Japan
Primary
Concomitant
Duodenal Ulcer Other Serious 55 Male 3/19/2007 Japan
Primary
Secondary
Splenectomy Hospitalization 6/6/2006 55 Male 3/24/2007 Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 12 Male 3/31/2007 Physician Ireland
Primary
Secondary
Vasculitis Other Serious 19 Male 4/20/2007 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 32 Female 5/4/2007 Japan
Primary
Secondary
Renal Impairment Other Serious 32 Female 5/14/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/25/2006 12 Male 5/23/2007 Physician Ireland
Primary
Secondary
Concomitant
Lymphoma Life Threatening 3/1/2007 41 Female 6/4/2007 Physician Japan
Primary
Secondary
Concomitant
Lymphoma Life Threatening 3/1/2007 41 Female 6/4/2007 Physician Japan
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 2/1/2006 43 Male 6/5/2007 Japan
Primary
Secondary
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
Kidney Transplant Rejection Hospitalization 9/26/2005 54 Female 190 lb 5/7/2007 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 1/9/2006 45 Male 145 lb 5/7/2007 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 12/20/2005 49 Female 5/7/2007 Other Health Professional United States
Primary
Concomitant
Renal Impairment Hospitalization 32 Female 7/12/2007 Japan
Primary
Secondary
Concomitant
Post Procedural Complication Death 6/28/2007 4 Female 7/14/2007 Physician Japan
Primary
Secondary
Subcutaneous Abscess Hospitalization 39 Male 7/18/2007 Japan
Primary
Secondary
Neutropenia Other Serious Female 7/19/2007 Japan
Primary
Secondary
Staphylococcal Infection Disability 11/14/2003 23 Male 115 lb 7/23/2007 Physician Japan
Primary
Secondary
Sepsis Other Serious 6/20/2006 74 Female 88 lb 7/23/2007 Physician Japan
Primary
Secondary
Staphylococcal Infection Disability 11/14/2003 23 Male 115 lb 7/25/2007 Japan
Primary
Secondary
White Blood Cell Count Increased Death 11/9/2003 15 Female 117 lb 7/25/2007 Japan
Primary
Secondary
Concomitant
Neutropenia Hospitalization Female 7/25/2007 Pharmacist Ireland
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 11/25/2006 12 Male 7/25/2007 Physician Ireland
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/25/2006 12 Male 7/25/2007 Physician Ireland
Primary
Secondary
Concomitant
Neutropenia Hospitalization Female 7/25/2007 Pharmacist Ireland
Primary
Concomitant
Wound Infection Staphylococcal Other Serious 39 Male 7/31/2007 Japan
Primary
Secondary
Hepatitis Fulminant Hospitalization 7/19/2007 7/31/2007 Physician Japan
Primary
Secondary
Hepatitis Fulminant Hospitalization 7/19/2007 3 Male 8/2/2007 Physician Japan
Primary
Secondary
Small Intestine Ulcer Other Serious 22 Male 8/2/2007 Physician Japan
Primary
Concomitant
Renal Tubular Disorder Other Serious 12/26/2006 59 Male 8/8/2007 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 11/16/2005 50 Female 106 lb 8/16/2007 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 8/31/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/25/2006 12 Male 9/14/2007 Physician Ireland
Primary
Secondary
Concomitant
Pylorectomy Other Serious 4/1/2006 55 Male 9/27/2007 Japan
Primary
Secondary
Sepsis Death 6/28/2007 4 Female 9/29/2007 Physician Japan
Primary
Secondary
Concomitant
Kaposi's Sarcoma Other Serious Male 9/24/2007 Physician France
Primary
Secondary
Lymphoma Death Male 9/21/2007 Physician France
Primary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 10/11/2007 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenia Death 41 Male 119 lb 10/5/2007 Physician France
Primary
Concomitant
Small Intestine Ulcer Other Serious 11/14/2003 23 Male 112 lb 11/6/2007 Physician Japan
Primary
Secondary
Concomitant
Lymphoma Death 41 Male 119 lb 10/31/2007 Physician France
Primary
Concomitant
Sepsis Death 6/28/2007 4 Female 11/9/2007 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/15/2007 Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious Female 11/22/2007 Japan
Primary
Secondary
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/25/2007 Physician Japan
Primary
Secondary
Concomitant
Vesicoureteric Reflux Other Serious 8 Female 11/25/2007 Japan
Primary
Secondary
Vesicoureteric Reflux Other Serious 8 Female 11/27/2007 Japan
Primary
Secondary
Sepsis Death 1/1/2007 4 Female 11/27/2007 Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 11/29/2007 Physician Japan
Primary
Secondary
Concomitant
Vesicoureteric Reflux Other Serious 12 Female 11/26/2007 Physician Japan
Primary
Concomitant
Splenectomy Hospitalization 3/1/2005 53 Female 115 lb 11/20/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/1/2005 53 Female 115 lb 12/4/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/1/2005 53 Female 115 lb 12/12/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Artery Stenosis Death 9/29/2007 49 Male 1/8/2008 Other Health Professional Spain
Primary
Secondary
Renal Artery Stenosis Death 9/29/2007 49 Male 1/4/2008 Other Health Professional Spain
Primary
Secondary
Sepsis Death 6/8/2007 4 Female 47 lb 1/2/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 9/20/2007 49 Male 1/16/2008 Physician Spain
Primary
Secondary
Urine Output Decreased Hospitalization 10/16/2003 48 Female 141 lb 1/7/2008 Physician Japan
Primary
Concomitant
Vaginal Infection Other Serious 5/26/2006 25 Female 1/17/2008 France
Primary
Secondary
Pneumonia Other Serious 1/1/2005 56 Female 2/9/2008 Japan
Primary
Secondary
Sepsis Death 1/1/2007 4 Female 2/12/2008 Japan
Primary
Secondary
Concomitant
Sepsis Death 1/1/2007 4 Female 2/12/2008 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 2/12/2008 Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 8/21/2007 53 Female 2/13/2008 Japan
Primary
Secondary
Concomitant
Dermatomyositis Other Serious 27 Male 2/14/2008 Japan
Primary
Concomitant
Renal Cell Carcinoma Other Serious 1/1/2005 56 Female 2/14/2008 Japan
Primary
Secondary
Renal Cell Carcinoma Life Threatening 1/1/2005 56 Female 2/18/2008 Japan
Primary
Secondary
Transplant Rejection Other Serious 8/21/2007 53 Female 2/19/2008 Japan
Primary
Secondary
Concomitant
Pancreatitis Necrotising Death 9/29/2007 49 Male 2/19/2008 Other Health Professional Spain
Primary
Secondary
Renal Impairment Other Serious 5/23/2006 38 Male 2/21/2008
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 3/1/2005 53 Female 115 lb 2/14/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death 1/1/2007 4 Female 2/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Vesicoureteric Reflux Other Serious 9 Male 2/28/2008 Physician Japan
Primary
Concomitant
Urine Output Decreased Hospitalization 10/16/2003 48 Female 141 lb 2/19/2008 Physician Japan
Primary
Concomitant
Ureteral Necrosis Other Serious 2/7/2005 31 Female 79 lb 3/6/2008 Physician Japan
Primary
Secondary

Drug Data