Simulect combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Erythema Infectiosum Hospitalization 1/18/2006 52 Female 137 lb 3/16/2006 Physician Canada
Primary
Secondary
Concomitant
Vanillyl Mandelic Acid Urine Increased Hospitalization 12/1/2003 61 Male 3/20/2006 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 1/1/2006 28 Female 112 lb 3/28/2006 Physician United Kingdom
Primary
Concomitant
Renal Impairment Other Serious 1/1/2006 Male 5 lb 3/28/2006 Physician United Kingdom
Primary
Concomitant
Nephropathy Hospitalization 32 Male 4/12/2006 Physician Germany
Primary
Secondary
Kidney Transplant Rejection Hospitalization 64 Female 4/12/2006 Physician Germany
Primary
Secondary
Acute Myocardial Infarction Death 2/22/2003 52 Male 6/5/2006 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 1/17/2006 52 Female 137 lb 6/5/2006 Physician Canada
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 36 Male 6/12/2006 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Renal Failure Other Serious 1/1/1996 43 Female 7/17/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Epididymitis Hospitalization 3/15/2003 38 Male 121 lb 8/12/2006 Physician Japan
Primary
Secondary
Liver Disorder Other Serious 40 Male 8/12/2006 Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 40 Male 8/22/2006 Japan
Primary
Secondary
Concomitant
Nephrogenic Fibrosing Dermopathy Hospitalization 46 Male 8/29/2006 Physician United States
Primary
Concomitant
Nephrogenic Fibrosing Dermopathy Hospitalization 50 Male 8/30/2006 Physician United States
Primary
Concomitant
Sepsis Life Threatening 6/12/2005 70 Male 9/25/2006 Physician Netherlands
Primary
Secondary
Concomitant
Vasodilatation Life Threatening 8/29/2006 60 Male 9/27/2006 Physician Germany
Primary
Concomitant
Multi-organ Failure Death 66 Female 10/16/2006 Other Health Professional United States
Primary
Concomitant
Renal Impairment Other Serious 12/1/2005 38 Male 10/23/2006 Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 1/1/2006 38 Male 11/3/2006 Japan
Primary
Secondary
Concomitant
Nephrogenic Fibrosing Dermopathy Hospitalization 46 Male 11/8/2006 Physician United States
Primary
Concomitant
Therapy Non-responder Hospitalization 49 Male 11/8/2006 Physician United States
Primary
Concomitant
Vasodilatation Life Threatening 8/29/2006 60 Male 11/30/2006 Physician Germany
Primary
Concomitant
Vasodilatation Life Threatening 8/29/2006 60 Male 11/30/2006 Physician Germany
Primary
Concomitant
Mechanical Ileus Other Serious 11 Male 12/8/2006 Japan
Primary
Concomitant
Mechanical Ileus Other Serious 11 Male 12/20/2006 Japan
Primary
Concomitant
Mechanical Ileus Life Threatening 8/30/2006 11 Male 12/22/2006 Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Other Serious 59 Female 2/13/2007 Japan
Primary
Secondary
Concomitant
Malaise Other Serious 59 Female 2/23/2007 Japan
Primary
Secondary
Concomitant
Nephrogenic Fibrosing Dermopathy Hospitalization 49 Male 3/1/2007 Physician United States
Primary
Concomitant
Oedema Peripheral Hospitalization 46 Male 3/1/2007 Physician United States
Primary
Secondary
Concomitant
Vasculitis Other Serious 19 Male 4/20/2007 Japan
Primary
Secondary
Concomitant
Wound Secretion Hospitalization 6/9/2006 63 Male 4/24/2007 Physician United States
Primary
Concomitant
Wound Secretion Hospitalization 6/9/2006 63 Male 4/24/2007 Physician United States
Primary
Concomitant
Liver Disorder Other Serious 40 Male 6/6/2007 Japan
Primary
Secondary
Concomitant
Venous Thrombosis Hospitalization 4/30/2007 50 Male 183 lb 6/13/2007 Physician Germany
Primary
Concomitant
Mechanical Ileus Life Threatening 8/30/2006 11 Male 7/3/2007 Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 8/30/2006 11 Male 7/5/2007 Japan
Primary
Secondary
Concomitant
Subcutaneous Abscess Hospitalization 39 Male 7/18/2007 Japan
Primary
Secondary
Neutropenia Other Serious Female 7/19/2007 Japan
Primary
Secondary
Wound Infection Staphylococcal Other Serious 39 Male 7/31/2007 Japan
Primary
Secondary
Thrombocytopenia Other Serious 3 40 lb 7/26/2007 Other Health Professional France
Primary
Concomitant
Thrombotic Microangiopathy Hospitalization 41 Female 8/9/2007 Physician India
Primary
Concomitant
Kaposi's Sarcoma Other Serious Male 9/24/2007 Physician France
Primary
Secondary
Graft Thrombosis Life Threatening 28 Male 11/6/2007 Physician India
Primary
Concomitant
Encephalopathy Other Serious 14 Female 11/17/2007 Japan
Primary
Secondary
Neutropenia Other Serious Female 11/22/2007 Japan
Primary
Secondary
Wound Dehiscence Hospitalization 52 Male 12/3/2007 Belgium
Primary
Secondary
Leukoencephalopathy Other Serious 3/1/1997 24 Female 2/13/2008 Japan
Primary
Secondary
Concomitant
Nuclear Magnetic Resonance Imaging Abnormal Other Serious 3/9/2007 24 Female 2/27/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/1/2005 29 Male 4/17/2008 Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 58 Male 5/20/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Zygomycosis Death 62 Male 6/6/2008 Physician United States
Primary
Secondary
Respiratory Distress Hospitalization 1/15/2008 6/13/2008 Other Health Professional France
Primary
Secondary
Concomitant
Encephalopathy Other Serious 14 Female 6/17/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Urinary Anastomotic Leak Other Serious 6/27/2002 12 Female 59 lb 6/19/2008 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 11 Male 7/10/2008 Physician Italy
Primary
Secondary
Iga Nephropathy Other Serious 25 Male 7/21/2008 Other Health Professional Japan
Primary
Secondary
Wound Infection Hospitalization 10/1/2006 7/25/2008 Other Health Professional Japan
Primary
Secondary
Pain Other Serious 25 Male 7/31/2008 Other Health Professional Japan
Primary
Secondary
Visual Field Defect Other Serious 52 Female 8/5/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Cyst Other Serious 3/1/2008 36 Male 8/6/2008 Other Health Professional Japan
Primary
Secondary
Wound Infection Hospitalization 10/1/2006 8/12/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Tract Haemorrhage Other Serious 9/1/2006 18 Male 8/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pain Other Serious 25 Male 8/22/2008 Other Health Professional Japan
Primary
Secondary
Pain Other Serious 25 Male 8/25/2008 Other Health Professional Japan
Primary
Secondary
Sepsis Hospitalization 33 Male 8/13/2008 Italy
Primary
Secondary
Concomitant
Pain Other Serious 25 Male 8/26/2008 Other Health Professional Japan
Primary
Secondary
Visual Field Defect Other Serious 52 Female 9/15/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Cyst Other Serious 3/1/2008 36 Male 9/19/2008 Other Health Professional Japan
Primary
Secondary
Wound Infection Hospitalization 10/1/2006 41 Male 9/22/2008 Other Health Professional Japan
Primary
Secondary
Myopathy Hospitalization 8/15/2000 Female 140 lb 10/23/2008 Physician Spain
Primary
Secondary
Concomitant
Urinary Anastomotic Leak Other Serious 6/27/2002 12 Female 59 lb 12/10/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 5/28/2006 39 Male 1/13/2009 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 5/28/2006 39 Male 109 lb 1/29/2009 Physician Japan
Primary
Secondary
Concomitant
Lower Gastrointestinal Haemorrhage Death 39 Female 2/24/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Liver Disorder Other Serious 43 Female 2/24/2009 Physician Japan
Primary
Concomitant
Transplant Rejection Other Serious 49 Male 2/27/2009 Other Health Professional Japan
Primary
Concomitant
Neurogenic Bladder Hospitalization 1/1/2006 48 Male 2/27/2009 Other Health Professional Japan
Primary
Secondary
Transplant Rejection Other Serious 49 Male 3/2/2009 Other Health Professional Japan
Primary
Concomitant
Pyrexia Death 39 Female 3/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Kidney Transplant Rejection Hospitalization 30 Male 3/5/2009 Other Health Professional Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 1/1/2006 48 Male 3/6/2009 Other Health Professional Japan
Primary
Secondary
Respiratory Tract Haemorrhage Other Serious 9/2/2006 18 Male 3/16/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Wound Infection Other Serious 3/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Parathyroid Gland Enlargement Other Serious 8 Male 3/25/2009 Other Health Professional Japan
Primary
Concomitant
Renal Tubular Atrophy Other Serious 8 Male 4/4/2009 Other Health Professional Japan
Primary
Secondary
Cytomegalovirus Infection Hospitalization 10/14/2008 57 Female 4/7/2009 Consumer Japan
Primary
Secondary
Concomitant
Neutropenia Hospitalization 1/20/2009 Male 194 lb 4/9/2009 Physician Canada
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 1/1/2006 48 Male 4/15/2009 Other Health Professional Japan
Primary
Secondary
Pyrexia Death 39 Female 4/27/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 3/27/2007 Female 99 lb 4/27/2009 Physician Canada
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 11/1/2008 58 Female 5/7/2009 Consumer Japan
Primary
Secondary
Concomitant
Stevens-johnson Syndrome Other Serious 62 Male 5/27/2009 Physician Korea, Republic Of
Primary
Concomitant
Vomiting Other Serious 6/1/2000 Female 6/10/2009 Other Health Professional France
Primary
Secondary
Transplant Rejection Other Serious 63 Female 6/23/2009 Other Health Professional Poland
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 4/1/2008 34 Female 6/29/2009 Other Health Professional Japan
Primary
Secondary
Skin Ulcer Other Serious 8/31/2004 42 Male 247 lb 7/8/2009 Physician United States
Primary
Concomitant
Cytomegalovirus Infection Hospitalization 12/3/2007 Male 7/14/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Skin Ulcer Other Serious 8/31/2004 42 Male 247 lb 7/16/2009 Physician United States
Primary
Concomitant
Wound Infection Other Serious 55 Female 7/21/2009 Physician Japan
Primary
Secondary
Concomitant
Wound Infection Other Serious 55 Female 7/21/2009 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 4/9/2009 Female 90 lb 8/18/2009 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 6/2/2009 15 Male 8/31/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 4/9/2009 Female 90 lb 9/8/2009 Physician Japan
Primary
Concomitant
Vascular Graft Complication Other Serious 40 Female 9/22/2009 Other Health Professional Japan
Primary
Secondary
Renal Failure Acute Other Serious 30 Male 9/24/2009 Physician United States
Primary
Concomitant
Transplant Failure Other Serious 62 Female 9/24/2009 Physician United States
Primary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 6 Female 10/23/2009 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Other Serious 6/2/2009 15 Male 10/27/2009 Other Health Professional Spain
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 6 Male 11/14/2009 Other Health Professional Ireland
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious 2/1/2008 61 Male 11/24/2009 Japan
Primary
Concomitant
Pulmonary Oedema Hospitalization 48 Female 12/4/2009 Kuwait
Primary
Secondary
Concomitant
Nephrolithiasis Other Serious 44 Male 12/22/2009 Other Health Professional Japan
Primary
Concomitant
Nephrolithiasis Other Serious 4/1/2003 Male 2/10/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 4/1/2003 Male 132 lb 2/19/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 60 Male 3/2/2010 Other Health Professional Japan
Primary
Concomitant
Loss Of Consciousness Other Serious 4/9/2009 Female 90 lb 3/3/2010 Other Health Professional Japan
Primary
Concomitant
Transplant Failure Hospitalization 4/1/2008 Female 141 lb 3/11/2010 Physician Germany
Primary
Concomitant
Renal Tubular Atrophy Other Serious 4/1/2008 8 Male 4/7/2010 Other Health Professional Japan
Primary
Concomitant
Ureteritis Other Serious 10/17/2005 48 Male 4/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Ureteritis Other Serious 10/5/2005 48 Male 4/30/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Septic Shock Other Serious 29 Female 5/12/2010 Other Health Professional France
Primary
Secondary
Concomitant
Tremor Other Serious 55 Male 5/12/2010 Other Health Professional France
Primary
Concomitant
Ureteritis Other Serious 10/5/2005 48 Male 5/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 12/18/2007 22 Male 165 lb 6/2/2010 Physician Germany
Primary
Secondary
Concomitant
Venous Thrombosis Other Serious 7/2/2009 46 Male 148 lb 6/9/2010 Physician Japan
Primary
Secondary
Renal Tubular Necrosis Hospitalization 6/15/2010 64 Female 174 lb 6/22/2010 Physician United States
Primary
Concomitant
Ureteric Stenosis Other Serious 12/1/2009 42 Female 6/28/2010 Physician Japan
Primary
Secondary
Idiopathic Thrombocytopenic Purpura Other Serious 64 Female 7/12/2010 Other Health Professional Japan
Primary
Concomitant
Transplant Rejection Other Serious 46 Female 7/12/2010 Japan
Primary
Concomitant
Transplant Failure Life Threatening 12/18/2007 22 Male 165 lb 7/12/2010 Physician Germany
Primary
Secondary
Cytomegalovirus Test Positive Hospitalization 7/17/2007 37 Female 106 lb 7/6/2010 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 57 Female 7/19/2010 Other Health Professional Japan
Primary
Concomitant
Tubulointerstitial Nephritis Other Serious 51 Male 7/19/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 5/22/2007 51 Male 182 lb 7/20/2010 Physician Germany
Primary
Concomitant
Thrombocytopenia Other Serious 64 Female 7/23/2010 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Infection Other Serious 46 Female 7/23/2010 Other Health Professional Japan
Primary
Concomitant
Transplant Failure Life Threatening 12/18/2007 22 Male 165 lb 7/27/2010 Physician Germany
Primary
Secondary
Thrombocytopenia Other Serious 64 Female 8/3/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Disease Death 51 Female 8/9/2010 Other Health Professional Japan
Primary
Concomitant
Renal Tubular Atrophy Other Serious 25 Male 8/9/2010 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Life Threatening 54 Male 8/21/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 28 Male 8/20/2010 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Life Threatening 54 Male 8/20/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 51 Female 8/20/2010 Other Health Professional Japan
Primary
Secondary
Kidney Transplant Rejection Other Serious 28 Male 8/27/2010 Other Health Professional Japan
Primary
Concomitant
Transplant Failure Other Serious 4/14/2006 44 Male 9/14/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 46 Female 9/24/2010 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 51 Female 9/27/2010 Other Health Professional Japan
Primary
Secondary

Drug Data