Mycophenolate Mofetil combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 2/2/2005 59 9/12/2005 Physician United States
Primary
Concomitant
Urine Output Decreased Death 55 Female 1/25/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 16 Male 1/17/2006 Physician Italy
Primary
Concomitant
Transaminases Increased Other Serious 9 Male 41 lb 5/8/2006 Other Health Professional Italy
Primary
Secondary
Concomitant
Mania Hospitalization 2/24/2006 42 Male 5/3/2006 United States
Primary
Secondary
Concomitant
Leukopenia Hospitalization 3/1/2006 18 Male 121 lb 4/26/2006 Other Health Professional Canada
Primary
Concomitant
Renal Failure Acute Other Serious 8/31/2002 49 Female 7/7/2006 France
Primary
Concomitant
Leukopenia Other Serious 3/1/2006 18 Male 121 lb 6/30/2006 Physician Canada
Primary
Concomitant
Ventricular Dysfunction Other Serious 1/12/2005 62 Male 7/7/2006 United States
Primary
Secondary
Concomitant
Immunosuppressant Drug Level Increased Hospitalization 2 Female 9/13/2006 Canada
Primary
Secondary
Concomitant
Weight Increased Other Serious 11/16/2005 17 Female 177 lb 9/26/2006 United States
Primary
Secondary
Concomitant
Soft Tissue Inflammation Hospitalization 7/1/2003 49 Female 10/4/2006 Physician United States
Primary
Secondary
Concomitant
Multiple Myeloma Death 1/31/2006 69 Male 10/16/2006 United States
Primary
Secondary
Concomitant
Mania Hospitalization 2/24/2006 42 Male 10/16/2006 United States
Primary
Secondary
Concomitant
Shock Life Threatening 8/18/2005 48 Male 10/12/2006 Physician France
Primary
Concomitant
Pyrexia Hospitalization 8/1/2006 58 Female 120 lb 10/17/2006 Physician United States
Primary
Concomitant
Vomiting Hospitalization 10/6/2006 60 Male 11/1/2006 Other Health Professional United States
Primary
Concomitant
Complications Of Transplant Surgery Other Serious NotSpecified 11/8/2006 Pharmacist United States
Primary
Concomitant
Urine Output Decreased Other Serious NotSpecified 11/8/2006 Pharmacist United States
Primary
Concomitant
Renal Tubular Disorder Other Serious 11/7/2006 Pharmacist United States
Primary
Concomitant
Wheezing Other Serious 11/7/2006 Pharmacist United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 11/7/2006 Pharmacist United States
Primary
Concomitant
Pyrexia Other Serious 11/7/2006 Pharmacist United States
Primary
Concomitant
Complications Of Transplanted Kidney Hospitalization 55 Female 190 lb 12/28/2006 Pharmacist United States
Primary
Concomitant
Haemodialysis Hospitalization 32 Male 176 lb 12/28/2006 Pharmacist United States
Primary
Concomitant
Renal Tubular Disorder Hospitalization 57 Male 165 lb 12/28/2006 Pharmacist United States
Primary
Concomitant
Nephritis Interstitial Other Serious 47 Male 185 lb 12/28/2006 Pharmacist United States
Primary
Concomitant
Pyrexia Other Serious 47 Female 176 lb 12/28/2006 Pharmacist United States
Primary
Concomitant
Renal Injury Other Serious 49 Male 227 lb 12/28/2006 Pharmacist United States
Primary
Concomitant
Small For Dates Baby Congenital Anomaly 3 lb 2/7/2007 Other Health Professional United States
Primary
Concomitant
Renal Infarct Life Threatening 27 Female 2/15/2007 United States
Primary
Concomitant
Renal Infarct Life Threatening 27 Female 2/15/2007 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 11/1/2004 57 Male 2/24/2007 Other Health Professional France
Primary
Secondary
Concomitant
Serum Sickness Hospitalization 2/24/2007 42 Male 3/5/2007 Physician United States
Primary
Concomitant
Respiratory Rate Increased Other Serious 3/2/2007 30 Female 205 lb 3/9/2007 Pharmacist United States
Primary
Concomitant
Dialysis Life Threatening 3/2/2007 27 Male 251 lb 3/12/2007 Pharmacist United States
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 11/7/2006 61 Male 165 lb 4/13/2007 Physician United States
Primary
Concomitant
Premature Baby Other Serious 0 Unknown 5/1/2007 Physician United States
Primary
Secondary
Concomitant
Sinus Tachycardia Other Serious 5/22/2007 53 Female 179 lb 6/20/2007 Pharmacist Canada
Primary
Concomitant
Type 1 Diabetes Mellitus Other Serious 5/5/2005 45 Female 156 lb 1/15/2007 Physician United States
Primary
Secondary
Serum Sickness Hospitalization 8/23/2006 53 Male 277 lb 1/15/2007 Physician United States
Primary
Concomitant
Renal Impairment Other Serious Female 7/26/2007 Other Health Professional United States
Primary
Concomitant
Renal Tubular Necrosis Hospitalization 1/6/2004 26 Male 159 lb 2/28/2005 Other Health Professional United States
Primary
Concomitant
Wound Infection Hospitalization 12/19/2003 39 Female 183 lb 2/28/2005 Other Health Professional United States
Primary
Concomitant
Renal Failure Acute Other Serious 12/30/2005 45 Female 121 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Subdural Effusion Hospitalization 6/20/2006 62 Male 218 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Ureteral Necrosis Hospitalization 5/20/2006 32 Male 198 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Pulmonary Oedema Hospitalization 2/28/2006 60 Male 153 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Kidney Transplant Rejection Other Serious 2/15/2006 20 Male 210 lb 1/15/2007 Physician United States
Primary
Concomitant
Kidney Transplant Rejection Other Serious 1/10/2006 42 Male 231 lb 1/15/2007 Physician United States
Primary
Concomitant
Oedema Peripheral Hospitalization 2/23/2006 60 Male 153 lb 1/15/2007 Physician United States
Primary
Concomitant
Perinephric Effusion Hospitalization 3/13/2006 47 Female 1/15/2007 Physician United States
Primary
Concomitant
Hyperkalaemia Hospitalization 3/6/2006 60 Male 153 lb 1/15/2007 Physician United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 7/9/2005 57 Male 242 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Mania Hospitalization 2/24/2006 42 Male 8/21/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 1 Male 8/31/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 1 Male 9/12/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Subdural Haemorrhage Hospitalization 1/17/2006 43 Female 10/10/2007 Physician United States
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 1 Male 10/9/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Drug Toxicity Other Serious 1 Male 10/10/2007 Pharmacist Canada
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 5/10/2005 60 Male 10/16/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/21/2007 57 Male 11/29/2007 Physician Germany
Primary
Concomitant
Urinary Tract Infection Enterococcal Other Serious 5/15/2007 61 Female 132 lb 11/30/2007 Physician United States
Primary
Concomitant
Vascular Injury Other Serious 5/21/2007 65 Female 101 lb 11/30/2007 Physician United States
Primary
Concomitant
Lymphocyte Count Decreased Hospitalization 55 Female 1/3/2008 Physician United States
Primary
Concomitant
Neutropenia Other Serious 1/12/2005 62 Male 192 lb 1/17/2008 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/12/2005 62 Male 1/22/2008 United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 52 Male 1/31/2008 Physician United States
Primary
Secondary
Neutropenia Other Serious 1/12/2005 62 Male 192 lb 2/7/2008 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 1/12/2005 62 Male 2/15/2008 United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 67 Male 2/18/2008 Physician United States
Primary
Secondary
Concomitant
Skin Graft Rejection Other Serious 12/15/2005 38 Female 2/26/2008 Physician France
Primary
Secondary
Serum Sickness Hospitalization 1/30/2008 44 Male 176 lb 2/15/2008 Physician Germany
Primary
Concomitant
Palpitations Hospitalization 8/18/2006 58 Male 165 lb 3/13/2008 Physician United States
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 12/4/2006 62 Male 165 lb 3/13/2008 Physician United States
Primary
Concomitant
Pyrexia Hospitalization 10/26/2005 54 Male 231 lb 3/13/2008 Physician United States
Primary
Concomitant
Hepatic Artery Stenosis Hospitalization 11/2/2006 60 Female 227 lb 3/13/2008 Physician United States
Primary
Concomitant
Tachypnoea Hospitalization 10/31/2006 59 Female 93 lb 3/27/2008 Physician United States
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 11/7/2006 62 Male 165 lb 3/28/2008 Physician United States
Primary
Concomitant
Respiratory Failure Hospitalization 6/16/2005 12 Male 5/21/2008 Physician United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 51 Female 6/13/2008 United States
Primary
Secondary
Concomitant
Tachycardia Other Serious 10/31/2006 59 Female 93 lb 6/20/2008 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 51 Female 6/30/2008 United States
Primary
Secondary
Concomitant
Premature Baby Other Serious 3 lb 7/7/2008 Other Health Professional United States
Primary
Secondary
Tachypnoea Other Serious 10/28/2006 59 Female 93 lb 6/27/2008 Physician United States
Primary
Concomitant
Liver Function Test Abnormal Hospitalization 5/16/2005 47 Female 132 lb 7/7/2008 Physician United States
Primary
Concomitant
Thrombosis Other Serious 64 Female 7/16/2008 Other Health Professional France
Primary
Concomitant
Systemic Inflammatory Response Syndrome Other Serious 38 Male 7/28/2008 Physician United Kingdom
Primary
Secondary
Premature Baby Other Serious 3 lb 7/29/2008 Other Health Professional United States
Primary
Secondary
Thrombocytopenia Hospitalization 1/1/2008 Male 7/23/2008 Physician Argentina
Primary
Concomitant
Transplant Rejection Other Serious 58 Male 8/13/2008 Physician United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 51 Female 8/19/2008 United States
Primary
Secondary
Venoocclusive Liver Disease Other Serious Male 8/20/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Off Label Use Other Serious 36 Female 8/22/2008 Italy
Primary
Concomitant
Venoocclusive Liver Disease Other Serious Male 8/22/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Off Label Use Other Serious 1/1/2006 36 Female 8/26/2008 Italy
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 1/18/2008 66 Male 172 lb 8/28/2008 Physician United States
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 7/9/2002 11 Female 9/2/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 51 Male 9/17/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9/18/2008 United States
Primary
Secondary
Urinary Tract Infection Other Serious 9/22/2008 United States
Primary
Secondary
Urinary Tract Infection Other Serious 9/22/2008 United States
Primary
Secondary
Thrombocytopenia Other Serious 52 Female 9/16/2008 Pharmacist United States
Primary
Concomitant
Pyrexia Hospitalization 8/28/2008 9/16/2008 Pharmacist United States
Primary
Concomitant
Wound Other Serious 2/1/2007 65 Female 10/6/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 65 Female 10/7/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 51 Female 10/7/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Distress Hospitalization 4/1/2008 Female 10/17/2008 Physician United States
Primary
Secondary
Concomitant
Vertigo Hospitalization 10/8/2008 69 Male 229 lb 10/23/2008 Pharmacist United Kingdom
Primary
Concomitant
Sepsis Hospitalization 5/10/2005 60 Male 10/23/2008 Physician United States
Primary
Secondary
Concomitant
Polyomavirus-associated Nephropathy Other Serious 51 Female 11/7/2008 Physician United States
Primary
Secondary
Thrombosis Hospitalization 45 Male 110 lb 11/21/2008 Physician India
Primary
Concomitant
Pneumonia Bacterial Hospitalization 53 Male 12/4/2008 Other Health Professional France
Primary
Secondary
Concomitant
Sinus Tachycardia Other Serious 3/13/2007 46 Female 2/21/2008 Other Health Professional United States
Primary
Concomitant
Chills Other Serious 3/1/2007 62 Female 160 lb 2/21/2008 Pharmacist United States
Primary
Concomitant
Visual Impairment Hospitalization 46 Male 12/12/2008 Other Health Professional Turkey
Primary
Secondary
Concomitant
Thrombosis Required Intervention 1/1/2005 47 Female 132 lb 2/9/2009 Physician Argentina
Primary
Concomitant
Transplant Rejection Hospitalization 14 Male 2/19/2009 Other Health Professional China
Primary
Secondary
Wound Dehiscence Death 61 Male 2/26/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious Male 3/16/2009 Physician Brazil
Primary
Secondary
Renal Tubular Necrosis Other Serious 2/20/2009 43 Female 202 lb 3/9/2009 Physician United States
Primary
Secondary
Concomitant
Wound Infection Other Serious 3/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 5/28/2004 Male 201 lb 4/3/2009 Physician Israel
Primary
Secondary
Concomitant
Aplasia Pure Red Cell Other Serious 8/3/2008 30 Female 4/7/2009 Physician Australia
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 6 Male 4/30/2009 Canada
Primary
Concomitant
Vomiting Hospitalization 4/18/2009 63 Female 145 lb 4/28/2009 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 4/1/2008 50 Male 4/14/2009 Physician India
Primary
Concomitant
Pneumonia Bacterial Death 3/9/2009 7 Female 5/8/2009 Physician Colombia
Primary
Concomitant
Pseudomonal Sepsis Other Serious 3/28/2009 60 Male 150 lb 5/26/2009 Physician Japan
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 2/4/2009 58 Male 206 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Small For Dates Baby Other Serious 3 lb 6/11/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pain Other Serious 7 Male 6/12/2009 Canada
Primary
Concomitant
Cytomegalovirus Infection Hospitalization 8/8/2003 Female 123 lb 6/23/2009 Physician Brazil
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 7/16/2003 Male 6/23/2009 Physician Germany
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 29 Male 6/25/2009 Other Health Professional United States
Primary
Secondary
Septic Shock Other Serious 6/29/2009 Other Health Professional United States
Primary
Concomitant
Surgical Procedure Repeated Other Serious 7/1/2009 Other Health Professional United States
Primary
Concomitant
Tremor Other Serious 61 Female 7/1/2009 Physician United States
Primary
Secondary
Pseudomonal Sepsis Other Serious 3/4/2009 60 Male 150 lb 6/15/2009 Physician Japan
Primary
Concomitant
Malaise Other Serious 4/24/2009 35 Male 6/30/2009 United Kingdom
Primary
Concomitant
Nephropathy Toxic Other Serious 2 Male 7/20/2009 Physician United States
Primary
Concomitant
Intra-uterine Death Other Serious 10/9/2006 Female 7/29/2009 Other Health Professional United States
Primary
Concomitant
Aplasia Pure Red Cell Other Serious 8/3/2008 30 Female 8/14/2009 Physician Australia
Primary
Secondary
Concomitant
Pleurisy Other Serious 1/5/2009 62 Female 8/3/2009 Other Health Professional France
Primary
Concomitant
Peritonitis Life Threatening 1/3/2009 Male 207 lb 8/19/2009 Physician Germany
Primary
Secondary
Concomitant
Impaired Healing Other Serious 6/21/2009 Female 8/21/2009 Physician Germany
Primary
Secondary
Therapeutic Agent Toxicity Other Serious 2/4/2009 58 Male 206 lb 8/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Aplasia Pure Red Cell Other Serious 8/3/2008 30 Female 8/26/2009 Physician United States
Primary
Secondary
Concomitant
Aplasia Pure Red Cell Other Serious 8/3/2008 30 Female 8/28/2009 Physician United States
Primary
Secondary
Concomitant
Small Intestine Ulcer Other Serious 5/1/2009 61 Male 8/19/2009 Physician United States
Primary
Concomitant

Drug Data