Melphalan Hydrochloride combined with Tacrolimus

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Strongyloidiasis Other Serious 63 Male 8/14/2009 Physician United States
Primary
Secondary
Renal Impairment Death 12/1/2008 61 Male 115 lb 9/8/2009 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 44 Female 9/11/2009 Other Health Professional Japan
Primary
Concomitant
Metastatic Malignant Melanoma Other Serious 53 Female 10/23/2009 Other Health Professional United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 50 Female 12/7/2009 Japan
Primary
Secondary
Concomitant
Sepsis Death Unknown 12/14/2009 United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Other Serious 12/8/2009 65 Female 1/7/2010 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 12/1/2008 50 Male 2/10/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Death 12/1/2008 61 Male 115 lb 2/12/2010 Physician Japan
Primary
Concomitant
Renal Failure Death 2/24/2010 Physician United States
Primary
Secondary
Concomitant
Unresponsive To Stimuli Hospitalization 12/8/2009 65 Female 142 lb 3/5/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Disorder Other Serious 16 Male 3/23/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 50 Male 3/23/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Renal Failure Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Thrombotic Microangiopathy Other Serious 3/30/2010 Consumer United States
Primary
Secondary
Pulmonary Alveolar Haemorrhage Death 3/29/2010 United States
Primary
Secondary
Respiratory Disorder Other Serious 7/6/2009 16 Male 110 lb 4/5/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 1/1/2008 44 Female 4/20/2010 Other Health Professional Japan
Primary
Concomitant
Pulmonary Haemorrhage Death 7/28/2009 57 Male 137 lb 4/12/2010 Physician Japan
Primary
Concomitant
Fungal Sepsis Death 4/2/2009 62 Male 157 lb 4/12/2010 Physician Japan
Primary
Concomitant
Viraemia Death 7/19/2009 58 Male 121 lb 4/12/2010 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization 4/25/2010 43 Male 5/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Weight Increased Required Intervention 44 Female 5/14/2010 Japan
Primary
Secondary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 5/14/2010 Physician United States
Primary
Secondary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 44 Female 5/28/2010 United States
Primary
Secondary
Concomitant
Serum Sickness Other Serious 63 Female 6/1/2010 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Required Intervention 44 Female 5/25/2010 Physician Japan
Primary
Concomitant
Renal Failure Death 45 5/28/2010 Physician United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 50 Female 6/4/2010 United States
Primary
Secondary
Concomitant
Viral Test Positive Other Serious 5/7/2009 1 Male 6/1/2010 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/25/2010 43 Male 6/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Serum Sickness Other Serious 63 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 44 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Other Serious 31 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 50 Female 6/8/2010 United States
Primary
Secondary
Concomitant
Sepsis Other Serious 6/9/2010 United States
Primary
Secondary
Concomitant
Varicella Virus Test Positive Other Serious 9 Male 6/23/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Renal Failure Death 45 Male 6/22/2010 Physician United States
Primary
Secondary
Concomitant
Trichosporon Infection Death 12/10/2008 54 Male 132 lb 6/18/2010 Physician Japan
Primary
Concomitant
Tracheomalacia Other Serious 5/7/2009 1 Male 8/13/2010 Physician United States
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 9/23/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 66 Male 9/28/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 61 Female 9/28/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 67 Female 9/28/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 61 Female 9/30/2010 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Death 57 Female 9/30/2010 Physician Japan
Primary
Concomitant
Transplant Failure Other Serious 7/30/2010 56 Male 10/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Stem Cell Transplant Death 5/19/2009 53 Female 101 lb 8/18/2010 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 1/1/2009 48 Female 88 lb 8/18/2010 Physician Japan
Primary
Concomitant
Malignant Neoplasm Progression Death 1/1/2009 50 Female 99 lb 8/18/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/8/2010 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 4/10/2009 4 Female 31 lb 10/11/2010 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 9/30/2009 18 Female 137 lb 10/18/2010 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 10/13/2010 Physician Japan
Primary
Concomitant
Leukaemia Recurrent Other Serious 35 Male 10/13/2010 Physician Japan
Primary
Concomitant
Myocarditis Death 54 Male 10/13/2010 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 7/2/2010 62 Male 130 lb 10/21/2010 Physician Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/21/2010 Physician Japan
Primary
Concomitant
Stenotrophomonas Infection Hospitalization 5/17/2010 59 Male 126 lb 10/27/2010 Physician Japan
Primary
Concomitant
Pericardial Effusion Other Serious 16 Female 10/29/2010 Physician Germany
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Death 9/21/2009 62 Female 126 lb 11/3/2010 Physician Japan
Primary
Concomitant
Oedema Life Threatening 1/29/2010 59 Male 176 lb 11/3/2010 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/7/2009 4 Female 10/26/2010 Physician Japan
Primary
Concomitant
Tumour Lysis Syndrome Death 11/15/2009 58 Male 108 lb 11/15/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2010 Physician Japan
Primary
Concomitant
Pyrexia Other Serious 2/11/2009 54 Male 152 lb 11/23/2010 Consumer Japan
Primary
Concomitant
Rash Other Serious 6/10/2010 2 Female 24 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening Male 112 lb 11/24/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Neoplasm Malignant Other Serious 3/1/2009 54 Male 152 lb 11/24/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 5/14/2010 2 Female 24 lb 11/29/2010 Physician Japan
Primary
Concomitant
Fall Other Serious 12/9/2009 11/29/2010 Physician Japan
Primary
Concomitant
Shock Haemorrhagic Other Serious 4/23/2009 54 Female 115 lb 11/12/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 15 Male 12/10/2010 Other Health Professional Japan
Primary
Concomitant
Staphylococcal Sepsis Other Serious 4/20/2010 1 Male 15 lb 12/10/2010 Physician Japan
Primary
Concomitant
Sepsis Other Serious 15 Male 12/13/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 9/7/2009 4 Female 12/2/2010 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Life Threatening 11/7/2010 49 Female 97 lb 12/30/2010 Physician Japan
Primary
Secondary
Concomitant
Inappropriate Antidiuretic Hormone Secretion Disability 15 Male 12/29/2010 Other Health Professional Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 3 Female 2/10/2011 Physician Japan
Primary
Secondary
Concomitant
Convulsion Other Serious 15 Male 2/3/2011 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 12 Female 2/25/2011 Physician United States
Primary
Secondary
Concomitant
Renal Failure Death 12/10/2008 54 Male 132 lb 2/28/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Death 4/25/2010 43 Male 168 lb 4/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Other Serious 65 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 31 4/13/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3 Male 4/15/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 66 4/15/2011 Physician United States
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 58 4/15/2011 Physician United States
Primary
Secondary
Concomitant
Influenza Other Serious 5/7/2009 1 Male 29 lb 4/12/2011 Physician United States
Primary
Secondary
Concomitant
Hyperbilirubinaemia Other Serious 11/16/2010 58 Female 117 lb 5/13/2011 Consumer United States
Primary
Secondary
Concomitant
Microangiopathy Hospitalization 5/1/2011 46 Female 162 lb 5/17/2011 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea Disability 11/16/2001 2 Female 19 lb 5/4/2011 Japan
Primary
Secondary
Concomitant
Bursitis Hospitalization 8/1/2008 43 Male 5/19/2011 Physician United States
Primary
Secondary
Concomitant
Atelectasis Hospitalization 12/25/2010 50 Male 5/20/2011 Physician Switzerland
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease Hospitalization 5/14/2010 2 Female 24 lb 5/20/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Test Positive Life Threatening 5/14/2010 2 Female 24 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 4/1/2011 Physician United States
Primary
Concomitant
Respiratory Failure Death 10/26/2009 59 Male 121 lb 5/31/2011 Physician Japan
Primary
Secondary
Concomitant
Engraft Failure Life Threatening 8/9/2010 Female 33 lb 6/1/2011 Physician Japan
Primary
Concomitant
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/2/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pneumonia Herpes Viral Death 46 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Idiopathic Pneumonia Syndrome Death 49 6/3/2011 Other Health Professional Japan
Primary
Secondary
Pulmonary Mycosis Other Serious 3/2/2010 63 Male 130 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Death 4/25/2010 Male 168 lb 6/8/2011 Physician United States
Primary
Secondary
Concomitant
Pneumonia Herpes Viral Death 46 5/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Idiopathic Pneumonia Syndrome Death 49 5/31/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 7 Male 6/10/2011 Physician United States
Primary
Secondary
Concomitant
Pancytopenia Other Serious 5/1/2007 Female 6/13/2011 Physician United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2 Female 6/13/2011 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 1/1/1991 16 Female 6/14/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Pericardial Effusion Death 10/15/2010 7 Female 42 lb 6/15/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 1/29/2010 52 Male 132 lb 6/20/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 7/18/2010 61 Female 110 lb 6/21/2011 Physician Japan
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 16 Female 6/22/2011 Other Health Professional Japan
Primary
Concomitant
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 5/20/2010 7 Male 42 lb 6/24/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Test Positive Other Serious 5/20/2010 7 Male 42 lb 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Bone Marrow Disorder Hospitalization 8/1/2008 43 Male 6/27/2011 Lawyer United States
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 4/1/2010 47 Male 201 lb 6/30/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 3/9/2010 55 Male 152 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 2/10/2010 23 Male 117 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Hospitalization 8/1/2008 43 Male 166 lb 6/30/2011 Physician United States
Primary
Secondary
Concomitant
Encephalitis Cytomegalovirus Other Serious 29 Female 7/5/2011 Physician United States
Primary
Concomitant
Hypertension Life Threatening 4/22/2010 13 Male 90 lb 7/5/2011 Physician Japan
Primary
Concomitant
Memory Impairment Hospitalization 2/10/2010 23 Male 117 lb 7/6/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 6/14/2010 7 Female 31 lb 7/8/2011 Physician Japan
Primary
Concomitant
Fatigue Other Serious 7/12/2011 Other Health Professional United States
Primary
Concomitant
Engraft Failure Other Serious 6/9/2010 10 Female 88 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Intestine Death 4/7/2010 54 Male 110 lb 7/15/2011 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Other Serious 6/9/2010 10 Female 88 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Abscess Bacterial Hospitalization 11/25/2009 61 Male 141 lb 7/18/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Death 12/10/2009 7 Male 53 lb 7/19/2011 Physician Japan
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Death 11/20/2009 34 Male 130 lb 7/22/2011 Physician Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Death 9/1/2010 52 Male 154 lb 7/22/2011 Physician Japan
Primary
Secondary
Concomitant
Cerebral Haemorrhage Death 1 Female 7/25/2011 Physician Japan
Primary
Secondary
Concomitant

Drug Data