Thymoglobulin combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Bradycardia Required Intervention 2/24/2006 Female 213 lb 7/31/2007 Pharmacist United States
Primary
Concomitant
Weight Increased Other Serious 5/29/2008 Female 114 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Pyrexia Life Threatening 10/26/2008 34 Female 11/13/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 12/28/2008 62 Male 2/9/2009 Physician United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 12/3/2008 55 Male 158 lb 2/24/2009 Physician United States
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 3/13/2009 Physician United States
Primary
Secondary
Concomitant
Viral Upper Respiratory Tract Infection Life Threatening 10/26/2008 34 Female 4/13/2009 Physician United States
Primary
Secondary
Concomitant
Hepatic Failure Death 2/23/2009 52 Male 117 lb 6/29/2009 Physician Japan
Primary
Concomitant
Small Intestine Ulcer Other Serious 5/1/2009 61 Male 8/19/2009 Physician United States
Primary
Concomitant
Sepsis Other Serious 5/1/2009 61 Male 9/14/2009 Physician United States
Primary
Concomitant
Tremor Hospitalization 8/16/2009 64 Male 11/23/2009 Other Health Professional United States
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 1/1/2009 41 Male 158 lb 12/17/2009 United States
Primary
Concomitant
Tremor Hospitalization 8/16/2009 64 Male 12/21/2009 Physician United States
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 1/1/2009 41 Male 158 lb 12/16/2009 Physician United States
Primary
Concomitant
Disseminated Cytomegaloviral Infection Life Threatening 2/23/2009 52 Male 126 lb 12/31/2009 Physician Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Required Intervention 6/8/2009 41 Male 158 lb 1/8/2010 Physician United States
Primary
Concomitant
Viral Haemorrhagic Cystitis Required Intervention 6/8/2009 41 Male 158 lb 1/4/2010 Physician United States
Primary
Concomitant
Hepatic Failure Life Threatening 2/23/2009 52 Male 126 lb 2/16/2010 Physician Japan
Primary
Concomitant
Vomiting Required Intervention 6/8/2009 41 Male 158 lb 3/31/2010 Physician United States
Primary
Concomitant
Pneumonia Cytomegaloviral Life Threatening 2/14/2009 52 Male 126 lb 4/20/2010 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 176 lb 6/16/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/13/2010 31 Female 6/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 10/19/2009 54 Male 132 lb 6/21/2010 Other Health Professional Japan
Primary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 6/23/2010 Physician United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 7/21/2010 Other Health Professional United States
Primary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 7/21/2010 Other Health Professional United States
Primary
Concomitant
Pyrexia Other Serious 9/21/2009 37 Female 93 lb 8/9/2010 Physician Japan
Primary
Concomitant
Hypoxia Hospitalization 6/7/2010 64 Male 8/13/2010 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/17/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 3/11/2009 23 Female 97 lb 8/31/2010 Physician Japan
Primary
Concomitant
Venoocclusive Disease Hospitalization 4/30/2010 31 Female 9/8/2010 Other Health Professional United States
Primary
Concomitant
Multi-organ Failure Other Serious 6/7/2010 64 Male 9/8/2010 Physician United States
Primary
Concomitant
Venoocclusive Disease Other Serious 4/30/2010 31 Female 176 lb 9/9/2010 Other Health Professional United States
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/13/2009 4 Female 31 lb 9/9/2010 Physician Japan
Primary
Concomitant
Febrile Neutropenia Other Serious 8/11/2009 10 Male 86 lb 9/20/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 9/23/2010 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
Staphylococcal Sepsis Hospitalization 3/15/2009 38 Male 128 lb 9/30/2010 Physician Japan
Primary
Concomitant
Tachycardia Hospitalization 4/28/2010 19 Female 115 lb 11/8/2010 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 Physician Japan
Primary
Concomitant
Therapeutic Agent Toxicity Other Serious 6/24/2009 49 Female 237 lb 10/26/2010 Other Health Professional Australia
Primary
Concomitant
Vomiting Other Serious 6/12/2010 12/1/2010 Consumer Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
Sepsis Life Threatening 7/28/2010 30 Female 99 lb 1/6/2011 Physician Japan
Primary
Concomitant
Therapeutic Response Decreased Other Serious 7/1/2009 48 Female 115 lb 1/6/2011 Physician Japan
Primary
Concomitant
Haemorrhage Death 4/13/2009 4 Female 31 lb 1/7/2011 Physician Japan
Primary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 8/6/2010 67 Female 110 lb 1/7/2011 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Other Serious 7/12/2010 52 Male 115 lb 1/10/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Hospitalization 11/20/2009 41 Male 126 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Other Serious 5/12/2009 56 Male 139 lb 1/10/2011 Physician Japan
Primary
Concomitant
Blood Pressure Increased Other Serious 8/9/2009 48 Female 115 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Multi-organ Failure Death 10/22/2010 54 Male 176 lb 1/21/2011 Physician Japan
Primary
Concomitant
Hypoxia Life Threatening 6/7/2010 64 Male 2/8/2011 Consumer United States
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Life Threatening 3/5/2010 2/9/2011 Physician Japan
Primary
Concomitant
Fungal Infection Hospitalization 6/24/2009 15 Male 126 lb 2/14/2011 Consumer Japan
Primary
Concomitant
Cardiac Failure Hospitalization 5/17/2010 2/18/2011 Physician Japan
Primary
Concomitant
Hypotension Life Threatening 1/22/2011 2/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Other Serious 3/12/2010 2 Male 22 lb 3/9/2011 Physician Japan
Primary
Concomitant
Pneumonia Bacterial Other Serious 1/29/2010 52 Male 132 lb 3/24/2011 Physician Japan
Primary
Secondary
Concomitant
Delirium Other Serious 6/16/2010 53 Male 154 lb 4/8/2011 Physician Japan
Primary
Concomitant
Toothache Hospitalization 9/21/2009 37 Female 93 lb 4/14/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Infection Hospitalization 10/25/2010 56 Male 243 lb 4/19/2011 Other Health Professional Australia
Primary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Fungal Infection Other Serious 10/13/2009 36 Male 143 lb 4/27/2011 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 5/16/2011 Physician Serbia
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 5/16/2011 Physician Serbia
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 3/12/2010 54 Female 95 lb 5/19/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Pruritus Hospitalization 3/12/2010 54 Female 95 lb 5/20/2011 Physician Japan
Primary
Secondary
Concomitant
Petechiae Other Serious 1/29/2010 49 Male 110 lb 5/20/2011 Physician Japan
Primary
Concomitant
Hyperuricaemia Hospitalization 3/15/2010 54 Female 95 lb 6/1/2011 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/17/2010 55 Male 168 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Serum Sickness Death 7/16/2010 68 Male 121 lb 6/16/2011 Physician Japan
Primary
Secondary
Concomitant
Disseminated Intravascular Coagulation Death 7/30/2010 49 Male 110 lb 6/16/2011 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
Viral Haemorrhagic Cystitis Death 7/28/2010 30 Female 99 lb 6/22/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 3/5/2010 6/24/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 2/10/2010 23 Male 117 lb 6/30/2011 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 7/21/2010 7/5/2011 Physician Japan
Primary
Secondary
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
Alanine Aminotransferase Increased Other Serious 6/17/2011 67 Male 7/6/2011 Physician United States
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 8/11/2009 19 Female 86 lb 7/18/2011 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 11/10/2010 49 Female 97 lb 8/2/2011 Physician Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Death 11/10/2010 49 Female 97 lb 8/3/2011 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 8/4/2011 Physician Japan
Primary
Secondary
Concomitant
Neutropenia Life Threatening 1/17/2011 27 Female 95 lb 8/5/2011 Physician Japan
Primary
Concomitant
Insomnia Other Serious 11/23/2010 62 Female 108 lb 8/8/2011 Physician Japan
Primary
Concomitant
Hypersensitivity Other Serious 11/21/2010 59 Male 126 lb 8/12/2011 Other Health Professional Canada
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Death 2/17/2010 8/19/2011 Physician Japan
Primary
Concomitant
Dizziness Hospitalization 9/27/2010 8/22/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/7/2011 20 Male 196 lb 8/22/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Death 5/21/2011 3 Male 26 lb 9/8/2011 Physician Japan
Primary
Concomitant
Rash Erythematous Other Serious Female 132 lb 9/15/2011 Pharmacist Brazil
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 11/21/2010 59 Male 126 lb 9/16/2011 Other Health Professional Canada
Primary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2010 6 Male 35 lb 9/19/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Colitis Hospitalization 10/25/2010 56 Male 243 lb 9/19/2011 Other Health Professional Australia
Primary
Concomitant
Idiopathic Thrombocytopenic Purpura Death 11/17/2009 6 Male 33 lb 9/19/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 5/19/2009 10 Male 49 lb 9/19/2011 Physician Japan
Primary
Concomitant
Pruritus Other Serious 2/13/2011 21 Female 120 lb 9/19/2011 Pharmacist Brazil
Primary
Concomitant
Cough Hospitalization 1/1/2010 55 Female 134 lb 9/22/2011 Physician Australia
Primary
Concomitant
Skin Reaction Other Serious Female 132 lb 9/27/2011 Pharmacist Brazil
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Life Threatening 7/28/2010 30 Female 99 lb 9/28/2011 Physician Japan
Primary
Concomitant
Thrombocytopenia Other Serious 3/11/2009 23 Female 97 lb 9/29/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Infection Hospitalization 11/21/2010 59 Male 126 lb 10/3/2011 Other Health Professional Canada
Primary
Concomitant
Enterocolitis Bacterial Death 4/27/2009 70 Female 75 lb 10/3/2011 Physician Japan
Primary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 10/3/2011 Physician Japan
Primary
Secondary
Concomitant
Hypertension Other Serious 6/12/2010 53 Male 154 lb 10/5/2011 Physician Japan
Primary
Concomitant
Pneumonia Death 6/24/2009 49 Female 237 lb 9/19/2011 Other Health Professional Australia
Primary
Concomitant
Corynebacterium Infection Life Threatening 10/27/2010 70 Male 110 lb 10/20/2011 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 3/24/2011 74 Female 101 lb 10/28/2011 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Life Threatening 6/24/2010 29 Female 99 lb 10/31/2011 Physician Japan
Primary
Concomitant
Liver Disorder Hospitalization 4/5/2011 8 Female 53 lb 11/2/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 10/13/2009 36 Male 143 lb 11/7/2011 Physician Japan
Primary
Concomitant
Urinary Tract Infection Pseudomonal Life Threatening 6/9/2010 73 Female 128 lb 11/9/2011 Physician Japan
Primary
Concomitant
Blood Glucose Increased Other Serious 2/11/2011 55 Female 123 lb 11/11/2011 Physician Japan
Primary
Concomitant
Aspergillus Test Positive Hospitalization 1/1/2010 55 Female 134 lb 11/14/2011 Physician Australia
Primary
Concomitant
Herpes Zoster Hospitalization 8/11/2009 19 Female 86 lb 11/15/2011 Physician Japan
Primary
Concomitant
Pleural Effusion Life Threatening 5/30/2011 27 Male 126 lb 11/17/2011 Physician Japan
Primary
Concomitant
Cardiomyopathy Death Male 33 lb 11/18/2011 Physician Japan
Primary
Secondary
Concomitant
Fall Other Serious 6/12/2010 70 Male 154 lb 11/23/2011 Physician Japan
Primary
Concomitant
Hypoxia Other Serious 5/18/2011 50 Female 84 lb 11/23/2011 Physician Japan
Primary
Concomitant
Multi-organ Failure Hospitalization 6/24/2009 15 Male 126 lb 11/23/2011 Physician Japan
Primary
Concomitant
Thyroid Cancer Other Serious 3/8/2010 74 Female 99 lb 11/25/2011 Physician Japan
Primary
Concomitant
Neutropenia Hospitalization 3/2/2011 1 Male 24 lb 11/29/2011 Physician Japan
Primary
Concomitant
Infection Disability 4/28/2010 19 Female 115 lb 11/29/2011 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 3/8/2010 74 Female 99 lb 12/1/2011 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 12/7/2009 21 Male 132 lb 12/1/2011 Physician Japan
Primary
Concomitant
Hypoalbuminaemia Other Serious 5/24/2011 50 Male 128 lb 12/7/2011 Physician Japan
Primary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 12/8/2011 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Death 6/24/2010 29 Female 99 lb 12/8/2011 Other Health Professional Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 8/18/2009 18 Female 108 lb 12/9/2011 Physician Japan
Primary
Concomitant
Staphylococcal Sepsis Life Threatening 3/2/2011 12 Male 84 lb 12/9/2011 Physician Japan
Primary
Concomitant
Organising Pneumonia Hospitalization 11/29/2010 7 Male 51 lb 12/12/2011 Physician Japan
Primary
Concomitant
Tumour Lysis Syndrome Life Threatening 7/28/2010 71 Male 159 lb 12/12/2011 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 10/25/2010 11 Male 66 lb 12/12/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Hepatitis Hospitalization 2/25/2011 2 Male 33 lb 12/12/2011 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 12/14/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Life Threatening 5/31/2011 9 Male 79 lb 12/19/2011 Physician Japan
Primary
Concomitant
Cytomegalovirus Chorioretinitis Hospitalization 8/24/2009 21 Male 104 lb 12/20/2011 Physician Japan
Primary
Concomitant
Shock Hospitalization 11/8/2010 75 Female 121 lb 12/22/2011 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 5/21/2011 3 Male 26 lb 12/23/2011 Physician Japan
Primary
Concomitant

Drug Data