Mycophenolate Mofetil (Cellcept) combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Cerebral Haemorrhage Death 62 Male 9/22/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 55 Male 9/23/2011 Other Health Professional Japan
Primary
Concomitant
Pulmonary Alveolar Haemorrhage Death 62 Male 9/23/2011 Physician Japan
Primary
Concomitant
Primary Effusion Lymphoma Other Serious 62 Male 9/23/2011 Other Health Professional Japan
Primary
Concomitant
Hepatic Encephalopathy Other Serious 5/4/2011 12 Female 9/23/2011 Physician France
Primary
Secondary
Concomitant
Posterior Reversible Encephalopathy Syndrome Other Serious 19 Male 9/25/2011 Other Health Professional Japan
Primary
Concomitant
Blood Creatinine Abnormal Other Serious 10/22/2007 45 Male 131 lb 9/25/2011 Physician Spain
Primary
Secondary
Concomitant
Pain Other Serious 8/1/2002 57 Female 150 lb 9/27/2011 Consumer United States
Primary
Secondary
Concomitant
Skin Lesion Other Serious 1/1/2006 25 Female 140 lb 9/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious 28 Female 9/28/2011 Other Health Professional Japan
Primary
Concomitant
Sepsis Other Serious 19 Male 10/10/2011 Other Health Professional Japan
Primary
Concomitant
Impaired Healing Other Serious 9/26/2011 58 Female 142 lb 10/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Neutropenia Hospitalization 9/12/2011 50 Male 10/13/2011 Other Health Professional France
Primary
Secondary
Concomitant
Anaemia Hospitalization 1/1/2011 30 Female 10/13/2011 Japan
Primary
Concomitant
Pancreatic Enzymes Increased Hospitalization 8/9/2011 50 Male 10/13/2011 Other Health Professional France
Primary
Secondary
Concomitant
Drug Resistance Other Serious Male 10/14/2011 Physician France
Primary
Concomitant
Immune System Disorder Other Serious 10/18/2011 Other Health Professional Japan
Primary
Secondary
Oesophageal Carcinoma Other Serious 8/5/2011 62 Male 265 lb 10/21/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Prerenal Failure Other Serious 2/1/2008 51 Male 218 lb 10/25/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Product Quality Issue Other Serious 10/7/2011 13 Female 94 lb 10/25/2011 Pharmacist United States
Primary
Concomitant
Convulsion Other Serious 11 Male 10/26/2011 United Kingdom
Primary
Secondary
Bacterial Infection Other Serious 10/28/2011 Other Health Professional United Kingdom
Primary
Secondary
Nephrotic Syndrome Other Serious 1/1/2007 23 Female 11/2/2011 Japan
Primary
Concomitant
Henoch-schonlein Purpura Nephritis Other Serious 1/1/2007 23 Female 11/2/2011 Physician Japan
Primary
Concomitant
Neutropenia Required Intervention 10/6/2011 63 Female 10/28/2011 Pharmacist United States
Primary
Concomitant
Blood Pressure Increased Other Serious 10/23/2011 53 Male 11/8/2011 China
Primary
Secondary
Renal And Pancreas Transplant Rejection Other Serious 2/1/2011 43 Female 11/8/2011 Other Health Professional Japan
Primary
Concomitant
Renal Failure Acute Other Serious 5/4/2011 12 Female 11/8/2011 Physician France
Primary
Secondary
Concomitant
Coagulopathy Other Serious 28 Female 11/9/2011 Other Health Professional Japan
Primary
Secondary
Sepsis Other Serious 19 Male 11/9/2011 Other Health Professional Japan
Primary
Secondary
Systemic Inflammatory Response Syndrome Other Serious 54 Male 11/9/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Other Serious 11/10/2011 Physician Germany
Primary
Concomitant
Wound Infection Other Serious 11/10/2011 Other Health Professional United Kingdom
Primary
Secondary
Cytomegalovirus Viraemia Hospitalization 12/15/2004 31 Female 11/14/2011 Japan
Primary
Secondary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Hospitalization 3/4/2007 41 Male 11/15/2011 Japan
Primary
Secondary
Concomitant
Impaired Healing Other Serious 9/26/2011 58 Female 219 lb 11/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Retention Other Serious Male 11/17/2011 Japan
Primary
Concomitant
Pain In Extremity Other Serious 12/1/2007 61 Male 11/17/2011 Physician United States
Primary
Secondary
Concomitant
Systemic Inflammatory Response Syndrome Other Serious 54 Male 11/18/2011 Germany
Primary
Secondary
Concomitant
Speech Disorder Hospitalization 5/1/2011 41 Male 11/18/2011 Other Health Professional China
Primary
Concomitant
Hemianopia Life Threatening 5/1/2010 48 Male 181 lb 11/21/2011 Physician Germany
Primary
Secondary
Concomitant
Pyelonephritis Hospitalization 4/1/2008 62 Male 11/21/2011 Germany
Primary
Secondary
Concomitant
Infectious Peritonitis Other Serious 1/1/2009 41 Male 11/23/2011 Physician Japan
Primary
Secondary
Pyrexia Hospitalization 5/21/2011 69 Female 117 lb 11/23/2011 Germany
Primary
Secondary
Concomitant
Blood Uric Acid Increased Other Serious 4/7/2006 27 Male 101 lb 11/23/2011 Japan
Primary
Secondary
Concomitant
Hepatitis B Dna Assay Positive Death Male 11/24/2011 Physician China
Primary
Concomitant
Staphylococcal Infection Other Serious 54 Male 11/28/2011 Germany
Primary
Secondary
Concomitant
Venous Thrombosis Limb Other Serious 44 Male 11/28/2011 Physician Japan
Primary
Concomitant
Pelvic Venous Thrombosis Other Serious 32 Female 11/28/2011 Physician Japan
Primary
Concomitant
Blood Creatinine Increased Other Serious 32 Female 11/28/2011 Physician Japan
Primary
Concomitant
Kidney Rupture Hospitalization 4/1/2009 53 Male 172 lb 11/29/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 4/1/2008 62 Male 11/29/2011 Germany
Primary
Secondary
Concomitant
Gait Disturbance Hospitalization 5/1/2011 41 Male 11/28/2011 Other Health Professional China
Primary
Concomitant
Aggression Life Threatening 5/1/2010 48 Male 181 lb 11/30/2011 Physician Germany
Primary
Secondary
Concomitant
Multi-organ Failure Death Male 12/1/2011 China
Primary
Concomitant
Iliac Artery Thrombosis Other Serious 32 Female 12/2/2011 Other Health Professional Japan
Primary
Concomitant
Venous Thrombosis Limb Hospitalization 44 Male 12/2/2011 Other Health Professional Japan
Primary
Concomitant
Herpes Zoster Hospitalization 12/18/2003 20 Male 12/2/2011 Japan
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 10/20/2004 44 Male 168 lb 12/2/2011 Japan
Primary
Secondary
Concomitant
Agranulocytosis Hospitalization 11/12/2011 64 Female 12/5/2011 Physician France
Primary
Secondary
Concomitant
Venous Thrombosis Limb Hospitalization 44 Male 12/5/2011 Japan
Primary
Concomitant
Fungal Infection Death 12/6/2011 China
Primary
Secondary
Concomitant
Primary Effusion Lymphoma Other Serious 62 Male 12/6/2011 Japan
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 3/28/2011 60 Female 143 lb 12/6/2011 Physician Germany
Primary
Concomitant
Renal Failure Acute Hospitalization 11/14/2011 62 Female 185 lb 12/7/2011 Physician Germany
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/15/2010 36 Male 137 lb 12/6/2011 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 2/14/2002 38 Male 238 lb 12/6/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Necrotising Herpetic Retinopathy Other Serious 48 Male 12/7/2011 Japan
Primary
Concomitant
Post Procedural Haemorrhage Other Serious 32 Female 12/7/2011 Physician Japan
Primary
Concomitant
Transplant Rejection Hospitalization 8/18/2009 53 Male 209 lb 12/8/2011 Germany
Primary
Secondary
Febrile Infection Hospitalization 3/31/2011 35 Female 123 lb 12/9/2011 Germany
Primary
Secondary
Concomitant
Iliac Artery Thrombosis Other Serious 32 Female 12/12/2011 Other Health Professional Japan
Primary
Concomitant
Deep Vein Thrombosis Hospitalization 44 Male 12/12/2011 Other Health Professional Japan
Primary
Concomitant
Infection Death Male 12/12/2011 Physician China
Primary
Concomitant
Pyelonephritis Acute Hospitalization 7/29/2011 65 Male 198 lb 12/12/2011 Physician France
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Other Serious 12/14/2011 Physician China
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 2/17/2011 60 Female 173 lb 12/14/2011 Germany
Primary
Secondary
Neutropenia Hospitalization 9/12/2011 50 Male 12/15/2011 Other Health Professional France
Primary
Secondary
Concomitant
Psoriasis Disability 10/1/2011 58 Male 243 lb 12/15/2011 Physician France
Primary
Secondary
Concomitant
Hirsutism Other Serious 12/15/2011 Uruguay
Primary
Secondary
Febrile Infection Hospitalization 3/31/2011 35 Female 123 lb 12/15/2011 Physician Germany
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 3/19/2007 38 Female 12/16/2011 Physician Japan
Primary
Secondary
Concomitant
Chest Pain Hospitalization 12/8/2011 34 Female 102 lb 12/13/2011 Other Health Professional United States
Primary
Concomitant
Abdominal Pain Hospitalization 1/6/2003 3 Female 12/19/2011 Japan
Primary
Secondary
Concomitant
Agranulocytosis Hospitalization 6/25/2010 49 Female 12/19/2011 Physician France
Primary
Concomitant
Lymphoproliferative Disorder Death 12/20/2011 Colombia
Primary
Secondary
Hepatotoxicity Other Serious 9/28/2010 53 Male 12/20/2011 Physician France
Primary
Concomitant
Arrhythmia Death 12/7/2011 16 Male 88 lb 12/20/2011 Pharmacist Japan
Primary
Concomitant
Fall Hospitalization 5/1/2011 48 Male 238 lb 12/22/2011 United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 5/1/2011 48 Male 238 lb 12/22/2011 Physician United States
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 11/14/2011 62 Female 185 lb 12/23/2011 Physician Germany
Primary
Concomitant
Infection Death 12/23/2011 Physician China
Primary
Concomitant
Transplant Rejection Hospitalization 2/15/2011 60 Male 187 lb 12/23/2011 Physician Germany
Primary
Secondary
Renal Failure Acute Hospitalization 9/12/2011 14 Female 12/27/2011 Other Health Professional France
Primary
Concomitant
Interacting
Jaundice Hospitalization 9/25/2011 14 Female 12/27/2011 Other Health Professional France
Primary
Secondary
Concomitant
Death Death Male 12/27/2011 Consumer China
Primary
Concomitant
Pyelonephritis Hospitalization 2/23/2010 64 Female 141 lb 12/28/2011 Physician France
Primary
Secondary
Concomitant
Psoriasis 9/1/2011 58 Male 243 lb 12/29/2011 Physician France
Primary
Secondary
Concomitant
Hypertension Other Serious 56 Male 12/31/2011 Physician Poland
Primary
Concomitant
Mesothelioma Malignant Death 47 Male 1/2/2012 Physician Japan
Primary
Concomitant
Upper Limb Fracture Other Serious 10/25/2005 47 Male 141 lb 1/2/2012 Japan
Primary
Secondary
Concomitant
Blood Uric Acid Increased Other Serious 4/7/2006 27 Male 101 lb 1/2/2012 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 12/16/2011 63 Male 172 lb 1/2/2012 Germany
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 9/12/2011 14 Female 82 lb 12/30/2011 Other Health Professional France
Primary
Concomitant
Interacting
Bicytopenia Hospitalization 10/3/2011 14 Female 1/3/2012 Other Health Professional France
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/21/2011 14 Female 1/3/2012 Other Health Professional France
Primary
Concomitant
Interacting
Deep Vein Thrombosis Hospitalization 4/15/2011 44 Male 1/5/2012 Other Health Professional Japan
Primary
Concomitant
Blood Creatinine Increased Hospitalization 7/5/2011 32 Female 1/5/2012 Other Health Professional Japan
Primary
Concomitant
Interstitial Lung Disease Death 29 Female 1/17/2012 Japan
Primary
Secondary
Concomitant
Cleft Lip And Palate Congenital Anomaly 11/9/2011 Female 5 lb 1/17/2012 Physician France
Primary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 29 Female 1/18/2012 Japan
Primary
Secondary
Concomitant
Pain Disability 1/16/2012 Lawyer United States
Primary
Concomitant
Renal Disorder Other Serious 21 Male 1/24/2012 Japan
Primary
Secondary
Concomitant
Hepatic Failure Disability 6/3/2005 61 Male 1/24/2012 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 10/7/2005 57 Female 1/24/2012 Japan
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 9/21/2011 14 Female 1/25/2012 Other Health Professional France
Primary
Concomitant
Interacting
Neutropenia Hospitalization 10/3/2011 14 Female 1/25/2012 Other Health Professional France
Primary
Secondary
Concomitant
Infection Other Serious 1/25/2012 France
Primary
Secondary
Transplant Rejection Hospitalization 12/16/2011 63 Male 172 lb 1/25/2012 Germany
Primary
Secondary
Concomitant
Complications Of Transplanted Kidney Hospitalization 12/15/2011 Male 1/25/2012 Physician France
Primary
Secondary
Concomitant
Pneumonia Death 12/21/2005 61 Female 136 lb 1/26/2012 Japan
Primary
Secondary
Concomitant
Portal Vein Thrombosis Death 1/27/2012 Physician Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 7/1/2008 31 Female 1/30/2012 Japan
Primary
Secondary
Concomitant
Drug Level Increased Hospitalization 9/12/2011 14 Female 82 lb 1/31/2012 Other Health Professional France
Primary
Concomitant
Interacting
Hepatic Neoplasm Malignant Hospitalization 12/1/2011 60 Male 244 lb 1/30/2012 Other Health Professional United States
Primary
Concomitant
Pancreatic Cyst Hospitalization 3/4/2007 41 Male 2/2/2012 Physician Japan
Primary
Secondary
Concomitant
Headache Hospitalization 8/21/2009 40 Female 2/7/2012 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Other Serious 9/15/2011 14 Female 2/7/2012 Other Health Professional France
Primary
Secondary
Concomitant
Type 1 Diabetes Mellitus Other Serious 1/1/2009 46 Male 238 lb 2/7/2012 Consumer France
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 75 Male 2/7/2012 Japan
Primary
Concomitant
Pneumonia Death 2/10/2010 40 Male 198 lb 2/9/2012 Physician Germany
Primary
Secondary
Progressive Multifocal Leukoencephalopathy Life Threatening 11/24/2011 56 Male 176 lb 2/9/2012 Physician Netherlands
Primary
Secondary
Concomitant
Sclerosing Encapsulating Peritonitis Other Serious 29 Male 2/9/2012 Other Health Professional Japan
Primary
Concomitant
Pneumonia Other Serious 74 Male 2/9/2012 Other Health Professional Japan
Primary
Concomitant
Treatment Failure Other Serious 2/9/2012 Other Health Professional France
Primary
Secondary
Deep Vein Thrombosis Other Serious 46 Male 2/10/2012 Japan
Primary
Concomitant
Sclerosing Encapsulating Peritonitis Other Serious 29 Male 2/10/2012 Japan
Primary
Concomitant
Cytomegalovirus Infection Other Serious 48 Male 2/10/2012 Other Health Professional Japan
Primary
Concomitant
Pneumonia Other Serious 70 Male 2/13/2012 Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 36 Male 2/13/2012 Physician Japan
Primary
Concomitant
Pericardial Effusion Other Serious 63 Male 2/14/2012 Physician Japan
Primary
Concomitant
Abdominal Abscess Life Threatening 2/10/2010 40 Male 198 lb 2/14/2012 Physician Germany
Primary
Secondary
Complications Of Transplanted Kidney Hospitalization 12/15/2011 40 Male 165 lb 2/14/2012 Physician France
Primary
Secondary
Concomitant
Iga Nephropathy Other Serious 16 Female 2/15/2012 Physician Japan
Primary
Concomitant
Renal Failure Acute Hospitalization 11/14/2011 62 Female 186 lb 2/16/2012 Physician Germany
Primary
Concomitant
Decreased Appetite Hospitalization 7/1/2006 51 Male 148 lb 2/16/2012 Physician Japan
Primary
Secondary
Concomitant
Gastrointestinal Mucosal Disorder Hospitalization 30 Male 2/17/2012 Japan
Primary
Concomitant
Sclerosing Encapsulating Peritonitis Other Serious 29 Male 2/17/2012 Japan
Primary
Concomitant
Deep Vein Thrombosis Other Serious 36 Male 2/17/2012 Physician Japan
Primary
Concomitant
Nephrosclerosis Hospitalization 6/1/2009 44 Male 131 lb 2/17/2012 Physician Germany
Primary
Secondary

Drug Data