Neoral combined with Simulect

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Pancytopenia Hospitalization 10/25/2004 48 Male 1/19/2006 Physician Spain
Primary
Secondary
Pyelonephritis Hospitalization 7/15/2002 37 Female 97 lb 1/24/2006 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Embolisation Other Serious 8/12/2004 56 Male 3/7/2006 Physician Italy
Primary
Secondary
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 4/23/2006 Physician Japan
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 7/15/2002 37 Female 97 lb 4/25/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 10/23/2003 15 Female 68 lb 5/23/2006 Physician Germany
Primary
Secondary
Renal Failure Life Threatening 11/17/2004 46 Female 6/6/2006 Consumer Japan
Primary
Secondary
Concomitant
Tremor Life Threatening 11/22/2004 31 Female 6/6/2006 Physician 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
Neurotoxicity Other Serious 9/6/2005 3 Male 7/18/2006 Physician France
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 7/15/2006 67 Male 309 lb 8/10/2006 Physician United States
Primary
Secondary
Urinary Tract Infection Enterococcal Hospitalization 11/8/2002 50 Male 124 lb 9/1/2006 Physician Spain
Primary
Secondary
Concomitant
Sepsis Hospitalization 4/17/2005 60 Male 9/14/2006 Physician Japan
Primary
Secondary
Hypertonia Hospitalization 6/4/2004 84 Female 212 lb 9/23/2006 Physician Germany
Primary
Secondary
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
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
Pyrexia Hospitalization 12/17/2004 44 Male 183 lb 10/24/2006 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 11/1/2005 29 Male 10/30/2006 Consumer United States
Primary
Secondary
Speech Disorder Disability 11/2/2005 23 Male 11/1/2006 Physician Japan
Primary
Secondary
Concomitant
Surgery Hospitalization 11/1/2005 29 Male 11/4/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 1/1/2006 38 Male 161 lb 11/21/2006 Japan
Primary
Secondary
Concomitant
Hypertension Hospitalization 6/4/2004 84 Female 212 lb 12/20/2006 Physician Germany
Primary
Secondary
Concomitant
Tremor Other Serious 6/28/2004 25 Male 66 lb 12/29/2006 Japan
Primary
Secondary
Concomitant
Thyroidectomy Other Serious 2/1/2006 26 Female 1/5/2007 Japan
Primary
Secondary
Tremor Other Serious 6/28/2004 25 Male 66 lb 1/18/2007 Japan
Primary
Secondary
Concomitant
Splenectomy Hospitalization 6/6/2006 55 Male 3/24/2007 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
White Blood Cell Count Decreased Other Serious 11/1/2005 29 Male 5/16/2007 Consumer United States
Primary
Secondary
Urate Nephropathy Hospitalization 3/21/2007 58 Female 6/13/2007 Physician Spain
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
Vomiting Hospitalization 3/21/2007 58 Female 7/13/2007 Physician Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/21/2007 58 Female 7/28/2007 Physician Spain
Primary
Secondary
Concomitant
Renal Tubular Disorder Other Serious 12/26/2006 59 Male 8/8/2007 Physician Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2007 66 Female 77 lb 8/31/2007 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 11/2/2005 23 Male 9/4/2007 Physician Japan
Primary
Secondary
Concomitant
Pylorectomy Other Serious 4/1/2006 55 Male 9/27/2007 Japan
Primary
Secondary
Superinfection Hospitalization 9/18/2007 55 Male 9/29/2007 Physician Germany
Primary
Secondary
Concomitant
Troponin Increased Hospitalization 10/25/2007 57 Male 11/6/2007 Physician Australia
Primary
Concomitant
Troponin Increased Hospitalization 10/25/2007 57 Male 11/7/2007 Physician Australia
Primary
Concomitant
Superinfection Hospitalization 9/18/2007 55 Male 11/14/2007 Physician Germany
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/15/2007 Japan
Primary
Secondary
Concomitant
Troponin Increased Hospitalization 10/25/2007 57 Male 11/20/2007 Physician Australia
Primary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 11/25/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatectomy Life Threatening 11/13/2007 65 Male 12/20/2007 Physician Germany
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 5/21/2007 56 Male 2/12/2008 Japan
Primary
Secondary
Concomitant
Ureteral Necrosis Other Serious 2/7/2005 31 Female 79 lb 3/6/2008 Physician Japan
Primary
Secondary
Ureteric Obstruction Other Serious 16 Male 3/16/2008 Japan
Primary
Secondary
Concomitant
Ureteric Obstruction Other Serious 16 Male 3/16/2008 Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 3/17/2008 Japan
Primary
Secondary
Urine Transitional Cells Present Hospitalization 30 Female 3/25/2008 Physician Japan
Primary
Concomitant
Urinary Tract Infection Hospitalization 3/26/2008 Japan
Primary
Secondary
Concomitant
Renin Increased Hospitalization 1/18/2008 9 Male 3/28/2008 Physician Japan
Primary
Concomitant
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 4/12/2008 France
Primary
Secondary
Concomitant
Vesicoureteric Reflux Hospitalization 10/1/2006 57 Male 4/21/2008 Japan
Primary
Secondary
Concomitant
Wheezing Life Threatening 3/25/2007 13 Male 93 lb 4/30/2008 France
Primary
Secondary
Concomitant
Tracheobronchitis Hospitalization 4/18/2008 39 Male 123 lb 4/30/2008 Physician Japan
Primary
Secondary
Concomitant
Tracheobronchitis Hospitalization 4/7/2008 39 Male 123 lb 5/8/2008 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
Tracheobronchitis Hospitalization 4/7/2008 Male 123 lb 6/24/2008 Physician Japan
Primary
Secondary
Concomitant
Tracheobronchitis Hospitalization 4/7/2008 Male 123 lb 6/24/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 7/8/2008 Physician Japan
Primary
Secondary
Concomitant
Tracheobronchitis Hospitalization 4/7/2008 Male 123 lb 7/10/2008 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 3/14/2007 Male 7/21/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2007 63 Female 8/4/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 1/1/2007 63 Female 8/4/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 46 Male 112 lb 8/26/2008 Other Health Professional Japan
Primary
Secondary
Urine Output Decreased Other Serious 46 Male 112 lb 9/4/2008 Other Health Professional Japan
Primary
Secondary
Thrombotic Microangiopathy Other Serious 12/20/2004 Female 73 lb 9/10/2008 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
Pulmonary Oedema Death 8/10/2006 46 Male 112 lb 10/6/2008 Japan
Primary
Secondary
Concomitant
Proteinuria Hospitalization 7/17/2008 Male 10/10/2008 Physician Japan
Primary
Secondary
Concomitant
Proteinuria Hospitalization 7/17/2008 Male 10/13/2008 Physician Japan
Primary
Secondary
Concomitant
Wound Secretion Hospitalization 7/17/2008 Male 10/10/2008 Physician Japan
Primary
Secondary
Concomitant
Wound Secretion Hospitalization 7/17/2008 Male 10/17/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/13/2000 Female 10/23/2008 Physician Spain
Primary
Secondary
Myopathy Hospitalization 8/15/2000 Female 140 lb 10/23/2008 Physician Spain
Primary
Secondary
Concomitant
White Blood Cell Disorder Hospitalization 5/16/2002 Male 10/23/2008 Physician Spain
Primary
Secondary
Retinal Vein Thrombosis Hospitalization 2/5/2001 Male 137 lb 10/23/2008 Physician Spain
Primary
Secondary
Liver Transplant Rejection Hospitalization 1/11/2002 Female 10/23/2008 Physician Spain
Primary
Secondary
Proteinuria Hospitalization 7/17/2008 Male 11/3/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 10/16/2008 Male 185 lb 10/31/2008 Physician Germany
Primary
Secondary
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
Lymphoproliferative Disorder Other Serious 10/22/2007 Male 12/2/2008 Other Health Professional Japan
Primary
Secondary
Lymphadenopathy Other Serious 10/1/2007 Male 12/8/2008 Other Health Professional Japan
Primary
Secondary
Focal Segmental Glomerulosclerosis Other Serious 12 Female 12/15/2008 Physician Japan
Primary
Concomitant
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
Wound Secretion Hospitalization 6/15/2008 Female 150 lb 12/31/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 1/8/2009 Physician Japan
Primary
Secondary
Concomitant
Wound Secretion Hospitalization 6/15/2008 Female 150 lb 1/12/2009 Physician Japan
Primary
Secondary
Concomitant
Focal Segmental Glomerulosclerosis Other Serious 12 Female 2/4/2009 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 3/21/2007 Female 2/13/2009 Physician Spain
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 7/28/2003 Male 121 lb 2/24/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 3/3/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 9/12/1999 Male 225 lb 3/6/2009 Physician Italy
Primary
Secondary
Sleep Disorder Hospitalization 9/14/1999 Male 132 lb 3/9/2009 Physician Italy
Primary
Secondary
Sepsis Life Threatening 4/15/2000 Male 137 lb 3/9/2009 Physician Italy
Primary
Secondary
Nervous System Disorder Hospitalization 9/1/1999 Female 141 lb 3/9/2009 Physician Italy
Primary
Secondary
Sudden Death Hospitalization 11/27/2007 36 Male 3/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Surgery Hospitalization 6/9/1999 Male 143 lb 3/9/2009 Physician Italy
Primary
Secondary
Ventricular Fibrillation Hospitalization 11/27/2007 36 Male 3/13/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Respiratory Tract Haemorrhage Other Serious 9/2/2006 18 Male 3/16/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 5/11/2007 Female 3/24/2009 Physician Japan
Primary
Secondary
Concomitant
Tuberculosis Other Serious 67 Male 3/26/2009 Physician Japan
Primary
Secondary
Urinary Tract Infection Other Serious 1/27/2009 Male 152 lb 3/30/2009 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 41 Male 3/31/2009 Other Health Professional Japan
Primary
Secondary
Tracheobronchitis Hospitalization 4/7/2008 Male 123 lb 4/8/2009 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 1/27/2009 Male 152 lb 4/8/2009 Physician Japan
Primary
Secondary
Concomitant
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
Toxic Encephalopathy Other Serious 7/18/2007 52 Female 4/30/2009 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 41 Male 5/4/2009 Other Health Professional Japan
Primary
Secondary
Tracheobronchitis Hospitalization 4/7/2008 Male 123 lb 5/5/2009 Physician Japan
Primary
Secondary
Concomitant
Tracheobronchitis Hospitalization 4/7/2008 Male 123 lb 5/5/2009 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 4/22/2007 Male 152 lb 5/14/2009 Physician Japan
Primary
Secondary
Concomitant
Tunnel Vision Other Serious 7/18/2007 52 Female 106 lb 5/18/2009 Physician Japan
Primary
Secondary
Concomitant
Wound Drainage Hospitalization 12/23/2008 Male 205 lb 5/20/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 6/28/2006 Female 148 lb 5/28/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 5/10/2009 Female 5/28/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Hyperamylasaemia Other Serious 2/24/2007 Female 93 lb 6/14/2009 Physician Japan
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 4/1/2008 41 Male 6/15/2009 Other Health Professional Japan
Primary
Secondary
Transplant Rejection Other Serious 11/18/2002 Male 139 lb 6/23/2009 Physician Japan
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 6/8/2005 Male 154 lb 6/24/2009 Physician Japan
Primary
Concomitant
Proteinuria Other Serious 1/1/2007 55 Male 6/29/2009 Other Health Professional Japan
Primary
Concomitant
Vocal Cord Paralysis Hospitalization 2/22/2008 Male 139 lb 7/3/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 12/10/2008 Male 174 lb 7/6/2009 Physician Japan
Primary
Concomitant
Anaphylactic Shock Other Serious 17 Female 7/6/2009 Physician France
Primary
Secondary
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
Tachycardia Life Threatening 2/22/2008 Female 7/20/2009 Other Health Professional France
Primary
Secondary
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
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
Anaphylactic Shock Life Threatening 2/22/2008 18 Female 8/7/2009 Physician United States
Primary
Secondary
Concomitant
Anaphylactic Shock Life Threatening 2/22/2008 Female 8/13/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Tubular Necrosis Other Serious 7/25/2006 Female 128 lb 8/17/2009 Physician Japan
Primary
Secondary
Concomitant

Drug Data