Prograf 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
Polymorphonuclear Chromatin Clumping Other Serious 5/20/2004 47 Male 119 lb 1/17/2006 Physician Japan
Primary
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
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
Thrombotic Microangiopathy Hospitalization 56 Male 3/17/2006 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
Graft Thrombosis Life Threatening 11/19/2003 63 Male 157 lb 5/12/2006 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 9/1/2004 37 Female 5/24/2006 Physician Japan
Primary
Concomitant
Tremor Life Threatening 11/22/2004 31 Female 6/6/2006 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 3/26/2005 70 Male 6/6/2006 United States
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 7/1/2005 23 Male 6/6/2006 United States
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 7/15/2002 37 Female 97 lb 6/15/2006 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Disability 11/14/2003 23 Male 115 lb 7/10/2006 Physician Japan
Primary
Secondary
Polyomavirus-associated Nephropathy Other Serious 4/1/2005 14 Male 6/30/2006 Physician Brazil
Primary
Concomitant
Renal Vein Thrombosis Hospitalization 9/1/2005 68 Female 5/5/2006 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 1/1/2006 52 Female 161 lb 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
Wound Infection Hospitalization 12/14/2004 64 Female 7/25/2006 United States
Primary
Secondary
Concomitant
Wheezing Other Serious 9/14/2005 30 Female 99 lb 8/10/2006 Japan
Primary
Concomitant
Urinary Tract Infection Staphylococcal Other Serious 5/9/2006 52 Male 8/8/2006 Spain
Primary
Concomitant
T-cell Lymphoma Death 12/1/2005 51 Male 8/4/2006 Physician Japan
Primary
Concomitant
Urinary Tract Infection Enterococcal Hospitalization 11/8/2002 50 Male 124 lb 9/1/2006 Physician Spain
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
Status Epilepticus Hospitalization 6/20/2006 64 Male 159 lb 9/27/2006 France
Primary
Secondary
Concomitant
Tremor Life Threatening 11/22/2004 31 Female 9/29/2006 Physician Japan
Primary
Secondary
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
Status Epilepticus Hospitalization 6/20/2006 64 Male 159 lb 10/5/2006 France
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
Rash Generalised Other Serious 66 Female 10/6/2006 Physician United States
Primary
Concomitant
Pyrexia Hospitalization 6/20/2006 74 Female 88 lb 10/19/2006 Physician Japan
Primary
Secondary
B-cell Lymphoma Death 53 Female 10/13/2006 Physician Japan
Primary
Concomitant
Skin Hyperpigmentation Other Serious 5/1/2003 63 Female 10/31/2006 Physician Poland
Primary
Secondary
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
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
Sense Of Oppression Other Serious 11/8/2006 Male 64 lb 2/2/2007 Physician Japan
Primary
Secondary
Concomitant
Immune System Disorder Hospitalization 59 Female 2/9/2007 Physician Japan
Primary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Other Serious Female 3/7/2007 Physician Japan
Primary
Concomitant
Vasculitis Other Serious 19 Male 3/14/2007 Physician Japan
Primary
Concomitant
Vasculitis Hospitalization 19 Male 3/23/2007 Physician Japan
Primary
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
Renal Impairment Other Serious 32 Female 5/15/2007 Physician Japan
Primary
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
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
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
Liver Transplant Rejection Death 5/10/2003 60 Female 7/10/2007 Physician Japan
Primary
Concomitant
Iliac Artery Thrombosis Other Serious 57 Male 7/18/2007 Physician Japan
Primary
Concomitant
Hepatitis Fulminant Hospitalization 7/19/2007 7/31/2007 Physician Japan
Primary
Secondary
Aortic Aneurysm Death 59 Male 7/13/2007 Physician Japan
Primary
Concomitant
Urinary Anastomotic Leak Death 1/1/2006 44 Male 7/13/2007 Physician Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 15 Female 7/20/2007 Physician Japan
Primary
Concomitant
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 Artery Stenosis Other Serious 57 Male 7/30/2007 Physician Japan
Primary
Concomitant
Tumour Embolism Death 1/1/2006 44 Male 7/30/2007 Physician Japan
Primary
Concomitant
Renal Disorder Hospitalization 47 Male 8/14/2007 Pharmacist Japan
Primary
Concomitant
Renal Tubular Necrosis Death 54 Male 8/13/2007 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious 55 Female 8/16/2007 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious 11/16/2005 50 Female 106 lb 8/16/2007 Physician Japan
Primary
Secondary
Concomitant
Urostomy Complication Hospitalization 11/3/2004 60 Male 8/22/2007 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 11/25/2006 12 Male 9/14/2007 Physician Ireland
Primary
Secondary
Concomitant
Renal Tubular Necrosis Death 54 Male 9/14/2007 Physician Japan
Primary
Concomitant
Sepsis Death 6/28/2007 4 Female 9/29/2007 Physician Japan
Primary
Secondary
Concomitant
Lymphoma Death Male 9/21/2007 Physician France
Primary
Concomitant
Renal Impairment Hospitalization 7/1/2005 23 Male 10/2/2007 United States
Primary
Secondary
Concomitant
Urostomy Complication Hospitalization 11/3/2004 60 Male 10/2/2007 Physician United States
Primary
Secondary
Concomitant
Renal Vein Thrombosis Other Serious 12/9/2005 34 Male 10/3/2007 United States
Primary
Secondary
Concomitant
Thrombocytopenia Death 41 Male 119 lb 10/5/2007 Physician France
Primary
Concomitant
Renal Impairment Hospitalization 7/1/2005 23 Male 10/10/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Post Procedural Myocardial Infarction Death 2/22/2003 52 Male 10/19/2007 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
Lymphoma Death 41 Male 119 lb 10/31/2007 Physician France
Primary
Concomitant
Renal Vein Thrombosis Other Serious 12/9/2005 34 Male 10/31/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Death 6/28/2007 4 Female 11/9/2007 Japan
Primary
Secondary
Concomitant
Sepsis Death 1/1/2007 4 Female 11/27/2007 Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Other Serious 16 Female 11/21/2007 Physician Japan
Primary
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
Wheezing Other Serious 9/14/2005 30 Female 99 lb 1/10/2008 Japan
Primary
Concomitant
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
Respiratory Distress Other Serious 29 Male 1/15/2008 Physician Canada
Primary
Concomitant
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
Transplant Rejection Other Serious 8/21/2007 53 Female 2/13/2008 Japan
Primary
Secondary
Concomitant
Renal Cell Carcinoma Other Serious 1/1/2005 56 Female 2/14/2008 Japan
Primary
Secondary
Multi-organ Failure Hospitalization 42 Female 2/12/2008 Physician Italy
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 Disorder Other Serious 69 Male 1/31/2008 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 5/23/2006 38 Male 2/21/2008
Primary
Secondary
Concomitant
Proteinuria Other Serious 33 Male 2/14/2008 Physician Japan
Primary
Concomitant
Meningitis Tuberculous Other Serious 1/1/2006 59 Male 2/15/2008 Physician Japan
Primary
Concomitant
Erythema Infectiosum Other Serious 42 Male 2/15/2008 Physician Japan
Primary
Concomitant
Plasmapheresis Other Serious Female 2/15/2008 Physician Japan
Primary
Concomitant
Ureteric Stenosis Other Serious 53 Female 2/14/2008 Physician Japan
Primary
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
Septic Shock Other Serious 1 Female 3/4/2008 Japan
Primary
Secondary
Proteinuria Hospitalization 33 Male 2/21/2008 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 47 Male 2/19/2008 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
Wound Dehiscence Death 52 Male 3/3/2008 Other Health Professional Belgium
Primary
Secondary
Transplant Rejection Other Serious 8/11/2007 53 Female 3/8/2008 Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 2 Female 22 lb 3/10/2008 Japan
Primary
Secondary
Concomitant
Thoracic Cavity Drainage Other Serious 7/1/2007 8 Female 3/12/2008 Physician Switzerland
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 6/25/2007 33 Male 148 lb 2/29/2008 Physician Japan
Primary
Concomitant

Drug Data