Tacrolimus combined with Thymoglobulin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
International Normalised Ratio Increased 12/2/2004 65 9/12/2005 Pharmacist United States
Primary
Concomitant
International Normalised Ratio Increased 2/2/2005 59 9/12/2005 Physician United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 9/20/2005 Female 9/22/2005 United States
Primary
Concomitant
Systemic Inflammatory Response Syndrome 11/20/2005 49 Male 1/23/2006 Pharmacist United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 5/17/2006 47 Female 6/7/2006 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 5/17/2006 47 Female 6/20/2006 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 5/17/2006 47 Female 6/27/2006 Other Health Professional United States
Primary
Concomitant
Retching Other Serious 6/23/2006 Female 148 lb 7/10/2006 Pharmacist United States
Primary
Concomitant
Therapeutic Response Decreased Hospitalization 6/13/2006 Female 209 lb 7/10/2006 Pharmacist United States
Primary
Concomitant
Procedural Hypertension Hospitalization 7/30/2006 Female 153 lb Pharmacist United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 7/10/2006 26 Female 151 lb 8/11/2006 Pharmacist United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7/14/2006 18 Female 99 lb 8/9/2006 Pharmacist United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 7/8/2006 68 Female 179 lb 8/9/2006 Pharmacist United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 5/17/2006 47 Female 8/4/2006 Other Health Professional United States
Primary
Concomitant
Septic Shock Life Threatening 7/27/2006 51 Male 181 lb 8/16/2006 Physician United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 7/8/2006 68 Female 179 lb 8/16/2006 Pharmacist United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 7/14/2006 18 Female 99 lb 8/16/2006 Pharmacist United States
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 7/8/2006 68 Female 179 lb 8/24/2006 Pharmacist United States
Primary
Concomitant
Immunosuppressant Drug Level Increased Hospitalization 2 Female 9/13/2006 Canada
Primary
Secondary
Concomitant
Shock Life Threatening 8/18/2005 48 Male 10/12/2006 Physician France
Primary
Concomitant
Convulsion Other Serious 11/26/2005 Female 10/16/2006 Physician France
Primary
Concomitant
Pyrexia Hospitalization 8/1/2006 58 Female 120 lb 10/17/2006 Physician United States
Primary
Concomitant
Tachycardia Hospitalization 8/30/2006 41 Male 181 lb 9/11/2006 Pharmacist United States
Primary
Concomitant
Vomiting Hospitalization 10/6/2006 60 Male 11/1/2006 Other Health Professional United States
Primary
Concomitant
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 11/9/2006 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
Sputum Culture Positive Life Threatening 10/19/2006 35 Female 294 lb 12/6/2006 Other Health Professional United States
Primary
Concomitant
Tachypnoea Life Threatening 10/25/2006 63 Male 12/13/2006 Other Health Professional 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
Restlessness Life Threatening 10/25/2006 63 Male 1/18/2007 Physician United States
Primary
Concomitant
Small For Dates Baby Congenital Anomaly 3 lb 2/7/2007 Other Health Professional United States
Primary
Concomitant
Weight Increased Other Serious 1/7/2007 50 Female 2/6/2007 Pharmacist Canada
Primary
Concomitant
Pyrexia Hospitalization 1/13/2005 37 Male 2/13/2007 Other Health Professional France
Primary
Secondary
Concomitant
B-cell Lymphoma Hospitalization 3/31/2006 48 Male 2/9/2007 Other Health Professional France
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 2/3/2006 44 Male 2/12/2007 Other Health Professional France
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 5/29/2006 Female 2/9/2007 Other Health Professional France
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/5/2006 43 Male 2/8/2007 Other Health Professional France
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 12/9/2005 46 Male 2/15/2007 Other Health Professional France
Primary
Secondary
Concomitant
Septic Shock Hospitalization 5/19/2005 39 Male 2/8/2007 Other Health Professional France
Primary
Secondary
Concomitant
Ascites Hospitalization 11/2/2004 46 Female 2/8/2007 Physician France
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 3/4/2005 32 Male 2/8/2007 Physician France
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 3/7/2005 45 Male 2/8/2007 Physician France
Primary
Secondary
Concomitant
Hernial Eventration Hospitalization 8/31/2006 50 Male 2/14/2007 Physician France
Primary
Secondary
Concomitant
Wound Evisceration Hospitalization 3/7/2006 44 Male 2/13/2007 Physician France
Primary
Secondary
Concomitant
Proteinuria Hospitalization 10/18/2004 41 Female 2/8/2007 Physician France
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 10/20/2005 46 Male 2/8/2007 Physician France
Primary
Secondary
Concomitant
Wound Evisceration Hospitalization 3/16/2005 37 Male 2/8/2007 Physician France
Primary
Secondary
Concomitant
Hydronephrosis Hospitalization 10/8/2004 45 Male 2/8/2007 Physician France
Primary
Secondary
Concomitant
Wound Evisceration Other Serious 10/29/2004 45 Male 2/8/2007 Physician France
Primary
Secondary
Concomitant
Tremor Other Serious 1/27/2007 30 Male 172 lb 3/1/2007 Pharmacist Canada
Primary
Concomitant
Urticaria Other Serious 1/23/2007 24 Female 106 lb 1/29/2007 Physician United States
Primary
Concomitant
Serum Sickness Hospitalization 2/24/2007 42 Male 3/5/2007 Physician United States
Primary
Concomitant
Peritoneal Effusion Hospitalization 11/2/2004 46 Female 3/6/2007 Physician France
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 11/7/2006 62 Male 165 lb 3/9/2007 Physician United States
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 11/7/2006 61 Male 165 lb 4/13/2007 Physician United States
Primary
Concomitant
Soft Tissue Disorder Hospitalization 1/9/2006 45 Female 154 lb 5/17/2007 Other Health Professional United States
Primary
Concomitant
Tremor Other Serious 1/27/2007 30 Male 172 lb 5/17/2007 Pharmacist Canada
Primary
Concomitant
Serum Sickness Other Serious 5/17/2007 France
Primary
Concomitant
Serum Sickness Hospitalization 8/23/2006 53 Male 277 lb 1/15/2007 Physician United States
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 1/28/2006 21 Male 1/15/2007 Physician Canada
Primary
Concomitant
Nephrectomy Required Intervention 8/21/2003 54 Male 214 lb 2/28/2005 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
Lung Squamous Cell Carcinoma Stage Unspecified Other Serious 12/1/2005 66 Male 243 lb 1/15/2007 Physician United States
Primary
Concomitant
Stomatitis Other Serious 5/31/2006 53 Female 138 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Epstein-barr Virus Infection Hospitalization 5/2/2006 62 Male 218 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Subdural Haemorrhage Life Threatening 6/24/2006 51 Female 124 lb 1/15/2007 United States
Primary
Concomitant
Ureteral Necrosis Hospitalization 5/20/2006 32 Male 198 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Cystitis Hospitalization 8/27/2006 44 Female 173 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
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
Complications Of Transplanted Liver Hospitalization 11/11/2005 62 Male 1/15/2007 Physician France
Primary
Concomitant
Kidney Transplant Rejection Hospitalization 7/9/2005 57 Male 242 lb 1/15/2007 Other Health Professional United States
Primary
Concomitant
Endocarditis Hospitalization 10/27/2005 68 Female 1/15/2007 Physician France
Primary
Concomitant
Serum Sickness Other Serious 4/30/2007 24 Female 194 lb 10/11/2007 Physician United States
Primary
Concomitant
Serum Sickness Other Serious 5/30/2007 30 Male 190 lb 10/11/2007 Physician United States
Primary
Concomitant
Liver And Pancreas Transplant Rejection Other Serious 10/14/2007 1 Male 23 lb 10/26/2007 Pharmacist Canada
Primary
Concomitant
Serum Sickness Hospitalization 10/10/2007 46 Male 172 lb 11/19/2007 Other Health Professional United Kingdom
Primary
Concomitant
Pneumonia Cytomegaloviral Hospitalization 8/1/2006 47 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
Neutropenia Other Serious 1/12/2005 62 Male 192 lb 2/7/2008 Physician United States
Primary
Secondary
Concomitant
Lymphocyte Count Increased Other Serious 1/1/2008 1/31/2008 Pharmacist United States
Primary
Concomitant
Serum Sickness Hospitalization 1/1/2007 54 Male 179 lb 1/25/2008 Pharmacist United States
Primary
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
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 5 Male 4/10/2008 Other Health Professional Germany
Primary
Secondary
Reversible Posterior Leukoencephalopathy Syndrome Other Serious 5 Male 4/14/2008 Other Health Professional Germany
Primary
Secondary
Liver Function Test Abnormal Required Intervention 4/6/2008 65 Male 223 lb 4/14/2008 Physician United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 4/13/2008 51 Male 234 lb 4/22/2008 Physician United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Required Intervention 4/6/2008 65 Male 223 lb 4/23/2008 Physician United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 4/6/2008 65 223 lb 4/29/2008 Physician United States
Primary
Secondary
Concomitant
Kidney Transplant Rejection Other Serious 12/19/2007 26 Female 5/2/2008 Pharmacist United States
Primary
Concomitant
Rash Other Serious 3/19/2008 60 Male 197 lb 5/5/2008 Physician United States
Primary
Secondary
Concomitant
Therapeutic Agent Toxicity Other Serious 5/12/2008 United States
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 4/13/2008 51 Male 234 lb 5/8/2008 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 6/16/2005 12 Male 5/21/2008 Physician United States
Primary
Secondary
Pulmonary Oedema Hospitalization 3/21/2008 50 Male 234 lb 5/20/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Tricuspid Valve Disease Other Serious 3/20/2008 60 Male 197 lb 5/15/2008 Physician United States
Primary
Secondary
Concomitant
Renal Tubular Necrosis Life Threatening 38 Male 5/22/2008 Physician Portugal
Primary
Concomitant
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
Respiratory Failure Other Serious 31 Male 7/18/2008
Primary
Secondary
Concomitant
Premature Baby Other Serious 3 lb 7/29/2008 Other Health Professional United States
Primary
Secondary
Hyperglycaemia Hospitalization 6/30/2008 Male 7/22/2008 Pharmacist United States
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 Disease Other Serious 8/18/2008 Physician United States
Primary
Secondary
Concomitant
Off Label Use Other Serious 36 Female 8/22/2008 Italy
Primary
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
Pneumonitis Other Serious 8/29/2008 United States
Primary
Concomitant
Wound Evisceration Hospitalization 10/12/2004 45 Male 8/20/2008 Other Health Professional France
Primary
Secondary
Concomitant
Wound Evisceration Hospitalization 3/16/2005 37 Male 8/20/2008 Other Health Professional France
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 10/18/2004 41 Female 8/20/2008 Other Health Professional France
Primary
Secondary
Concomitant
Ascites Hospitalization 11/2/2004 46 Female 8/20/2008 Physician France
Primary
Secondary
Concomitant
Pyrexia Hospitalization 1/13/2005 37 Male 8/20/2008 Physician France
Primary
Secondary
Concomitant
Wound Evisceration Hospitalization 3/7/2006 44 Male 8/20/2008 Physician France
Primary
Secondary
Concomitant
Wound Evisceration Other Serious 10/29/2004 45 Male 8/20/2008 Physician France
Primary
Secondary
Concomitant
Hydronephrosis Hospitalization 10/8/2004 45 Male 8/20/2008 Physician France
Primary
Secondary
Concomitant
Shock Haemorrhagic Hospitalization 10/20/2005 46 Male 8/20/2008 Physician France
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 9/8/2008 Physician United States
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

Drug Data