Cyclosporine combined with Simulect

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Polymorphonuclear Chromatin Clumping Other Serious 5/20/2004 47 Male 119 lb 1/17/2006 Physician Japan
Primary
Concomitant
Renal Cyst Hospitalization 10/4/2005 79 Male 4/7/2006 Other Health Professional United States
Primary
Concomitant
Urine Output Decreased Other Serious 49 Male 4/27/2006 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
Viral Dna Test Positive Other Serious 25 Male 5/11/2006 Other Health Professional Australia
Primary
Secondary
Concomitant
Necrosis Ischaemic Hospitalization 5/22/2006 48 Female 5/31/2006 Italy
Primary
Concomitant
Transplant Rejection Other Serious 36 Male 6/12/2006 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 36 Male 6/10/2006 Physician Switzerland
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 11/30/2005 44 Male 6/20/2006 Italy
Primary
Secondary
Concomitant
Splenectomy Other Serious 4/5/2005 37 Male 185 lb 6/27/2006 Pharmacist United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 7/3/2005 40 Female 143 lb 7/12/2006 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 1/1/1996 43 Female 7/17/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Viral Test Positive Other Serious 62 Male 8/8/2006 Other Health Professional Germany
Primary
Secondary
Suture Related Complication Other Serious 7/3/2005 40 Female 143 lb 8/11/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 6/15/2005 31 Female 132 lb 9/5/2006 Physician Japan
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious Male 10/2/2006 Japan
Primary
Secondary
Concomitant
Papillary Thyroid Cancer Other Serious 26 Female 10/3/2006 Physician Japan
Primary
Secondary
Thyroidectomy Other Serious 26 Female 10/11/2006 Japan
Primary
Secondary
Surgery Hospitalization Male 10/11/2006 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Required Intervention 55 Female 10/5/2006 Germany
Primary
Secondary
Concomitant
Renal Impairment Other Serious 12/1/2005 38 Male 10/23/2006 Japan
Primary
Secondary
Concomitant
Hepatitis Other Serious 11/1/2005 20 Male 10/25/2006 Consumer United States
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 42 Male 10/26/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 42 Male 10/28/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 1/1/2006 38 Male 11/3/2006 Japan
Primary
Secondary
Concomitant
Pain In Extremity Disability 42 Male 11/24/2006 Italy
Primary
Concomitant
White Blood Cell Count Increased Other Serious 7/1/2005 46 Male 1/31/2007 United States
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 9/1/2005 74 Male 201 lb 2/10/2007 Physician Germany
Primary
Secondary
Inflammation Other Serious 4/28/2006 65 Male 3/16/2007 Consumer United States
Primary
Concomitant
Duodenal Ulcer Other Serious 55 Male 3/19/2007 Japan
Primary
Secondary
Swelling Life Threatening 2/27/2007 65 Male 3/21/2007 Consumer United States
Primary
Concomitant
Swelling Life Threatening 2/27/2007 65 Male 4/5/2007 Consumer United States
Primary
Concomitant
Swelling Life Threatening 2/27/2007 65 Male 6/8/2007 Consumer United States
Primary
Concomitant
Liver Transplant Rejection Death 5/10/2003 60 Female 7/10/2007 Physician Japan
Primary
Concomitant
Deep Vein Thrombosis Other Serious 7/1/2007 9/12/2007 Physician Germany
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 7/1/2007 9/13/2007 Physician Germany
Primary
Secondary
Concomitant
Deep Vein Thrombosis Other Serious 7/1/2007 9/13/2007 Physician Germany
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 9/1/2005 74 Male 201 lb 10/24/2007 Physician Germany
Primary
Secondary
Lymphocele Other Serious 5 Female 11/25/2007 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
Lymphocele Other Serious 5 Female 11/27/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 57 Female 12/12/2007 Japan
Primary
Secondary
Deep Vein Thrombosis Other Serious 7/1/2007 12/12/2007 Physician Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 57 Female 12/22/2007 Japan
Primary
Secondary
Renal Tubular Disorder Other Serious 12/26/2006 59 Male 1/31/2008 Japan
Primary
Secondary
Renal Tubular Disorder Other Serious 12/26/2006 59 Male 2/7/2008 Japan
Primary
Secondary
Therapeutic Agent Toxicity Hospitalization 16 Male 2/13/2008 Japan
Primary
Secondary
Concomitant
Ureteric Perforation Other Serious 52 Male 2/13/2008 Japan
Primary
Secondary
Concomitant
Dermatomyositis Other Serious 27 Male 2/14/2008 Japan
Primary
Concomitant
Plasmapheresis Other Serious Female 2/15/2008 Physician Japan
Primary
Concomitant
Ureteric Obstruction Other Serious 16 Male 2/28/2008 Japan
Primary
Secondary
Concomitant
Ureteric Obstruction Other Serious 16 Male 2/28/2008 Japan
Primary
Secondary
Concomitant
Ureteric Perforation Other Serious 52 Male 2/29/2008 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 47 Male 2/19/2008 Physician Japan
Primary
Concomitant
Zygomycosis Other Serious 52 Female 3/29/2008 United States
Primary
Secondary
Concomitant
Vesicoureteric Reflux Hospitalization 9 Female 3/28/2008 Japan
Primary
Secondary
Nephrotic Syndrome Other Serious Female 3/18/2008 Physician Japan
Primary
Concomitant
Wound Infection Hospitalization 25 Male 4/11/2008 Physician United States
Primary
Concomitant
Haemorrhage Other Serious 6/28/2004 64 Male 4/29/2008 Pharmacist Canada
Primary
Secondary
Concomitant
Lymphocele Other Serious 5 Female 6/18/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Infarct Other Serious 1/1/2007 63 Female 7/22/2008 Other Health Professional Japan
Primary
Secondary
Pneumonia Other Serious 7/28/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Tract Haemorrhage Other Serious 9/1/2006 8/4/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
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
Respiratory Tract Haemorrhage Other Serious 9/1/2006 18 Male 8/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 57 Female 8/28/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 52 Female 9/15/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 9/4/2006 Male 117 lb 11/12/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 9/4/2006 Male 117 lb 11/25/2008 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Alveolar Haemorrhage Hospitalization 9/4/2006 Male 117 lb 12/2/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 2/23/2004 64 Male 12/2/2008 Physician Australia
Primary
Secondary
Concomitant
Urine Analysis Abnormal Other Serious 7/1/2007 61 Male 1/15/2009 Other Health Professional Japan
Primary
Secondary
Focal Segmental Glomerulosclerosis Other Serious 7 Female 38 lb 1/30/2009 Physician Japan
Primary
Concomitant
Sudden Death Other Serious 36 Male 2/24/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Tuberculosis Other Serious 67 Male 2/24/2009 Other Health Professional Japan
Primary
Secondary
Focal Segmental Glomerulosclerosis Other Serious 7 Female 38 lb 2/25/2009 Physician Japan
Primary
Concomitant
Viral Infection Other Serious 1/1/2007 Male 2/26/2009 Other Health Professional Japan
Primary
Secondary
Renal Graft Loss Other Serious 1/1/2007 53 Male 2/27/2009 Other Health Professional Japan
Primary
Secondary
Neutrophil Count Decreased Other Serious 41 Male 2/27/2009 Other Health Professional Japan
Primary
Secondary
Ventricular Fibrillation Death 36 Male 3/3/2009 Physician Japan
Primary
Concomitant
Tuberculosis Other Serious 3/1/2008 67 Male 3/3/2009 Physician Japan
Primary
Concomitant
Histiocytosis Haematophagic Other Serious 30 Male 3/3/2009 Physician Japan
Primary
Concomitant
Sudden Death Other Serious 36 Male 3/5/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Vessel Disorder Other Serious 12/1/2007 53 Male 3/9/2009 Other Health Professional Japan
Primary
Secondary
Neutrophil Count Decreased Other Serious 41 Male 3/10/2009 Other Health Professional Japan
Primary
Secondary
Viral Infection Other Serious 1/1/2007 Male 3/10/2009 Other Health Professional Japan
Primary
Secondary
Ventricular Fibrillation Death 36 Male 3/23/2009 Physician Japan
Primary
Concomitant
Cytomegalovirus Infection Hospitalization 10/14/2008 57 Female 4/7/2009 Consumer Japan
Primary
Secondary
Concomitant
Urinary Bladder Atrophy Other Serious 53 Male 4/8/2009 Physician Japan
Primary
Concomitant
Retroperitoneal Haematoma Death 3/10/2009 Male 4/20/2009 Physician Germany
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 11/1/2008 58 Female 5/7/2009 Consumer Japan
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 12/3/2007 Male 6/10/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Ascites Other Serious 59 Male 6/15/2009 Other Health Professional Japan
Primary
Concomitant
Weight Increased Other Serious 59 Male 6/24/2009 Other Health Professional Japan
Primary
Concomitant
Weight Increased Other Serious 59 Male 6/24/2009 Other Health Professional Japan
Primary
Concomitant
Weight Increased Other Serious 59 Male 6/24/2009 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 55 Female 7/14/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 8/6/2008 Male 128 lb 7/14/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Hospitalization 9/29/2008 Male 173 lb 7/14/2009 Physician Germany
Primary
Secondary
Concomitant
Cytomegalovirus Infection Hospitalization 12/3/2007 Male 7/14/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 37 Female 7/16/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Other Serious 40 Female 7/16/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 37 Female 7/26/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Shock Haemorrhagic Other Serious 40 Female 7/27/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sepsis Death 55 Female 8/13/2009 Physician Japan
Primary
Concomitant
Renal Tubular Necrosis Other Serious 37 Female 8/17/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Varicella Hospitalization 1/1/2007 43 Male 8/17/2009 Physician Japan
Primary
Concomitant
Sepsis Death 55 Female 9/1/2009 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 8/6/2008 Male 128 lb 10/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 37 Female 10/12/2009 Other Health Professional Japan
Primary
Concomitant
Large Intestine Perforation Other Serious 54 Female 10/12/2009 Other Health Professional Japan
Primary
Secondary
Retroperitoneal Haematoma Death 3/3/2009 Male 10/13/2009 Physician Germany
Primary
Secondary
Concomitant
Thrombosis Hospitalization 9/15/2009 Male 10/14/2009 Physician Germany
Primary
Secondary
Thrombosis Hospitalization 9/15/2009 Male 10/14/2009 Physician Germany
Primary
Secondary
Pyrexia Other Serious 54 Female 10/19/2009 Other Health Professional Japan
Primary
Secondary
Thrombosis Hospitalization 9/15/2009 Male 126 lb 10/20/2009 Physician Germany
Primary
Secondary
Vitreous Haemorrhage Other Serious 37 Female 10/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 6 Female 10/23/2009 Physician Japan
Primary
Concomitant
Thrombosis Hospitalization 9/15/2009 Male 126 lb 10/30/2009 Physician Germany
Primary
Secondary
Nephrotic Syndrome Other Serious 31 Female 12/28/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 37 Female 1/26/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Cerebral Infarction Death 46 Male 2/2/2010 Physician Japan
Primary
Concomitant
Cerebral Infarction Death 46 Male 2/17/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 1/1/2009 39 Male 3/2/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Cerebral Infarction Death 46 Male 3/5/2010 Physician Japan
Primary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 6 Female 3/15/2010 Physician Japan
Primary
Concomitant
Nephrotic Syndrome Other Serious 31 Female 3/19/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Hospitalization 12/10/2009 Female 3/23/2010 Physician Germany
Primary
Secondary
Concomitant
Vena Cava Thrombosis Life Threatening 5/24/2008 Male 198 lb 3/30/2010 Physician Germany
Primary
Secondary
Therapeutic Agent Toxicity Hospitalization 12/10/2009 Female 3/30/2010 Physician Germany
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Hospitalization 12/10/2009 Female 3/30/2010 Physician Germany
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 3/18/2010 65 Female 4/14/2010 Physician Germany
Primary
Secondary
Tuberculosis Other Serious 3/1/2008 67 Male 4/19/2010 Physician Japan
Primary
Concomitant
Ureteritis Other Serious 10/17/2005 48 Male 4/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 3/18/2010 65 Female 5/1/2010 Physician Germany
Primary
Secondary
Diabetes Mellitus Hospitalization 5/14/2008 65 Female 183 lb 5/28/2010 Other Health Professional Australia
Primary
Secondary
Concomitant
Varicella Hospitalization 1/1/2007 43 Male 7/6/2010 Physician Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 7/9/2010 69 Female 176 lb 8/12/2010 Physician Germany
Primary
Secondary
Interacting
Urinary Tract Infection Hospitalization 7/9/2010 69 Female 176 lb 8/26/2010 Physician Germany
Primary
Secondary
Interacting
Staphylococcal Infection Death 3/3/2009 68 Male 9/10/2010 Physician Germany
Primary
Secondary
Concomitant
Vena Cava Thrombosis Other Serious 5/24/2008 25 Male 198 lb 9/20/2010 Physician Germany
Primary
Secondary
Vena Cava Thrombosis Life Threatening 5/24/2008 25 Male 198 lb 10/4/2010 Physician Germany
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Female 10/25/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Transaminases Increased Other Serious 50 Female 10/28/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Oral Candidiasis Other Serious 69 Female 11/2/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 4/1/2010 20 Female 11/4/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Vasculitis Other Serious 69 Female 11/11/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 4/1/2010 20 Female 11/18/2010 Other Health Professional Japan
Primary
Secondary
Concomitant

Drug Data