Methotrexate combined with Ursodiol

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Abdominal Pain Hospitalization 5/4/2006 Male 143 lb 8/3/2006 Physician United States
Primary
Concomitant
Venoocclusive Disease Other Serious 10/14/2006 11 Female 60 lb 11/30/2006 Physician Canada
Primary
Concomitant
Tumour Lysis Syndrome Other Serious 10/14/2006 11 Female 60 lb 1/4/2007 Physician Canada
Primary
Concomitant
Skin Lesion Other Serious 0 Male 2/15/2007 Other Health Professional Turkey
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 8/10/2004 55 Female 5/4/2007 Japan
Primary
Secondary
Vomiting Other Serious 5/28/2007 51 Male 186 lb 8/22/2007 Physician United States
Primary
Concomitant
Vomiting Other Serious 5/28/2007 51 Male 186 lb 9/7/2007 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 10/14/2006 11 Female 60 lb 11/8/2007 Physician Canada
Primary
Secondary
Concomitant
Gastritis Hospitalization 3/18/2008 Male 148 lb 4/3/2008 Physician United States
Primary
Concomitant
Injection Site Pain Female 135 lb 6/12/2008 Consumer United States
Primary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 8/15/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 10/16/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Platelet Count Decreased Other Serious Male 10/17/2008 Other Health Professional Japan
Primary
Concomitant
Shock Other Serious 11/30/2007 Male 35 lb 11/3/2008 Other Health Professional Brazil
Primary
Concomitant
Vision Blurred Hospitalization 12/14/2007 Male 52 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Vomiting Hospitalization 7/22/2007 Male 97 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 11/5/2008 Other Health Professional Brazil
Primary
Concomitant
Injection Site Rash 1/22/2009 19 Female 135 lb 5/15/2009 Consumer United States
Primary
Concomitant
Injection Site Irritation 3/1/2008 Female 140 lb 6/12/2009 Consumer United States
Primary
Concomitant
Weight Increased Other Serious 3/31/2006 22 Male 137 lb 6/22/2009 Japan
Primary
Concomitant
Urticaria Other Serious 12/9/2008 7 Female 7/13/2009 Other Health Professional Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 48 Female 9/9/2009 Other Health Professional Japan
Primary
Concomitant
Urinary Tract Infection Death Female 163 lb 11/9/2009 United Kingdom
Primary
Concomitant
Multi-organ Failure Death 10/1/2009 52 Male 12/22/2009 Physician Japan
Primary
Concomitant
No Therapeutic Response Death 10/1/2009 52 Male 132 lb 1/29/2010 Physician Japan
Primary
Concomitant
Pyrexia Hospitalization 3/14/2010 Male 180 lb 3/18/2010 United States
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 12/6/2009 64 Female 3/23/2010 Consumer Canada
Primary
Concomitant
Weight Increased Hospitalization 1/1/2002 Female 4/22/2010 Physician Japan
Primary
Concomitant
No Adverse Event 64 Female 5/3/2010 Consumer Canada
Primary
Concomitant
Tibia Fracture Other Serious 12/6/2009 64 Female 5/3/2010 Consumer Canada
Primary
Concomitant
No Adverse Event 64 Female 5/28/2010 Consumer Canada
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 12/14/2009 72 Male 132 lb 6/4/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Sepsis Hospitalization 12/14/2009 72 Male 132 lb 6/14/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 1/6/2010 67 Female 115 lb 6/17/2010 Physician Japan
Primary
Secondary
Concomitant
Vaginal Haemorrhage Other Serious 1/1/2008 32 Female 122 lb 6/21/2010 Consumer United States
Primary
Secondary
Concomitant
Polymyositis Hospitalization 11/5/2009 63 Female 94 lb 7/2/2010 Physician Japan
Primary
Concomitant
Pharyngeal Oedema Hospitalization 3/19/2010 27 Male 7/23/2010 Physician Japan
Primary
Concomitant
Blood Alkaline Phosphatase Increased Other Serious 6/8/2010 74 Male 191 lb 7/27/2010 Physician United States
Primary
Concomitant
Tibia Fracture Other Serious 12/6/2009 64 Female 99 lb 8/4/2010 Physician Canada
Primary
Concomitant
Pyrexia Other Serious 9/21/2009 37 Female 93 lb 8/9/2010 Physician Japan
Primary
Concomitant
Shock Other Serious 1/6/2010 67 Female 115 lb 8/17/2010 Physician Japan
Primary
Secondary
Concomitant
Polymyositis Hospitalization 11/5/2009 63 Female 94 lb 8/17/2010 Physician Japan
Primary
Concomitant
Pharyngeal Oedema Hospitalization 3/18/2010 27 Male 8/20/2010 Physician Japan
Primary
Concomitant
Respiratory Distress Hospitalization 5/3/2010 2 Male 8/16/2010 Physician United States
Primary
Concomitant
Pharyngeal Oedema Hospitalization 3/18/2010 27 Male 9/8/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 4/13/2009 4 Female 31 lb 9/9/2010 Physician Japan
Primary
Concomitant
Venoocclusive Disease Other Serious 9/24/2010 Physician United States
Primary
Concomitant
Unresponsive To Stimuli Other Serious 9/16/2009 22 Male 169 lb 9/28/2010 Physician United States
Primary
Secondary
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
Pelvic Fluid Collection Other Serious 8/7/2010 63 Female 10/11/2010 Consumer United States
Primary
Concomitant
Pruritus Hospitalization 9/30/2009 18 Female 137 lb 10/18/2010 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 1/17/2010 Male 168 lb 11/22/2010 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 5/26/2010 Male 18 lb 11/24/2010 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
White Blood Cell Count Decreased Other Serious 1/29/2010 49 Male 110 lb 12/13/2010 Physician Japan
Primary
Concomitant
Hip Fracture Other Serious 8/7/2010 63 Female 12/15/2010 Physician United States
Primary
Concomitant
Respiratory Failure Death 1/5/2011 Other Health Professional United States
Primary
Secondary
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
Blood Pressure Increased Other Serious 8/9/2009 48 Female 115 lb 1/10/2011 Physician Japan
Primary
Secondary
Concomitant
Drug Dose Omission 9/3/2010 65 Female 1/30/2011 Consumer United States
Primary
Concomitant
Hypotension Life Threatening 1/22/2011 2/22/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Klebsiella Sepsis Life Threatening 1/10/2011 15 Female 150 lb 3/4/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Extremity Necrosis Disability 1/10/2011 15 Female 150 lb 3/15/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Extremity Necrosis Disability 1/10/2011 15 Female 150 lb 3/17/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 5/16/2005 15 Male 159 lb 3/21/2011 Physician United States
Primary
Concomitant
Abdominal Pain Hospitalization Male 143 lb 3/21/2011 Physician United States
Primary
Concomitant
Abdominal Pain Upper Hospitalization 2/15/2006 16 Male 145 lb 3/21/2011 Other Health Professional United States
Primary
Concomitant
Gastritis Hospitalization 3/18/2008 18 Male 148 lb 3/22/2011 Physician United States
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
Septic Shock Death 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 4/15/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Rash Hospitalization 3/15/2010 54 Female 95 lb 4/20/2011 Physician Japan
Primary
Secondary
Concomitant
Hepatotoxicity Hospitalization 1/1/2009 71 Female 110 lb 4/21/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Hip Fracture Hospitalization 8/7/2010 63 Female 4/29/2011 Physician United States
Primary
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
Candida Test Positive Hospitalization 3/12/2010 54 Female 95 lb 5/25/2011 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 22 Male 4/1/2011 Physician United States
Primary
Concomitant
Liver Disorder Hospitalization 3/26/2010 54 Female 95 lb 6/3/2011 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/17/2010 55 Male 168 lb 6/7/2011 Physician Japan
Primary
Secondary
Concomitant
Neuropathy Peripheral Hospitalization Male 6/15/2011 Physician United States
Primary
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 Hospitalization 5/25/2010 23 Female 73 lb 6/23/2011 Physician Japan
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 12/17/2010 49 Female 137 lb 6/27/2011 Physician Japan
Primary
Secondary
Concomitant
Pancreatitis Other Serious 2/10/2010 23 Male 117 lb 6/30/2011 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
Pulmonary Tuberculosis Hospitalization 1/1/2009 71 Female 110 lb 7/7/2011 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Macrocytosis Other Serious 45 Female 7/12/2011 Physician Spain
Primary
Concomitant
Gastric Cancer Other Serious 6/24/2011 72 Male 116 lb 7/27/2011 Physician Japan
Primary
Secondary
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
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
Abdominal Pain Upper Hospitalization 2/15/2006 16 Male 145 lb 8/12/2011 Other Health Professional United States
Primary
Concomitant
Gastritis Hospitalization 3/18/2008 18 Male 148 lb 8/12/2011 Physician United States
Primary
Concomitant
Dizziness Hospitalization 9/27/2010 8/22/2011 Physician Japan
Primary
Concomitant
Hepatic Failure Hospitalization 6/16/2011 23 Male 307 lb 8/18/2011 Physician United States
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Septic Shock Death 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Cytomegalovirus Test Positive Other Serious 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Death 8/31/2011 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Haemolytic Anaemia Hospitalization 2/3/2010 6 Male 35 lb 9/19/2011 Physician Japan
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
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
Venoocclusive Liver Disease Other Serious 1/1/2011 4 Male 37 lb 10/11/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Hospitalization 12/17/2010 49 Female 137 lb 10/17/2011 Physician Japan
Primary
Secondary
Concomitant
Haematemesis Other Serious 4 Male 38 lb 10/14/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 4/5/2011 8 Female 53 lb 11/2/2011 Physician Japan
Primary
Concomitant
Urinary Tract Infection Pseudomonal Life Threatening 6/9/2010 73 Female 128 lb 11/9/2011 Physician Japan
Primary
Concomitant
Hypoxia Other Serious 5/18/2011 50 Female 84 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
Gastric Cancer Other Serious 6/21/2011 72 Male 116 lb 11/30/2011 Japan
Primary
Secondary
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
Computerised Tomogram Thorax Abnormal Other Serious 12/17/2010 49 Female 137 lb 12/5/2011 Physician Japan
Primary
Secondary
Concomitant
Enterococcal Infection Hospitalization 2/10/2010 23 Male 117 lb 12/8/2011 Physician Japan
Primary
Secondary
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
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
Graft Versus Host Disease In Intestine Other Serious 1/1/2010 27 Male 12/7/2011 Other Health Professional Japan
Primary
Secondary
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
Bile Duct Cancer Death 5/1/2011 69 Male 12/22/2011 Physician Japan
Primary
Secondary
Concomitant
Candidiasis Hospitalization 1/1/2010 23 Male 117 lb 12/28/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Haemolytic Anaemia Life Threatening 11/17/2009 6 Male 33 lb 12/30/2011 Physician Japan
Primary
Concomitant
Epstein-barr Virus Associated Lymphoproliferative Disorder Death 3/11/2009 9 Male 49 lb 12/30/2011 Physician Japan
Primary
Concomitant
Graft Versus Host Disease In Skin Other Serious 4/22/2010 13 Male 90 lb 1/9/2012 Physician Japan
Primary
Concomitant
Decreased Appetite Hospitalization 12/7/2011 66 Female 101 lb 1/16/2012 Other Health Professional Japan
Primary
Secondary
Concomitant
Pyrexia Life Threatening 7/13/2010 6 Female 44 lb 2/6/2012 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Death 2/7/2009 57 Male 139 lb 2/7/2012 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 6/8/2009 6 Male 33 lb 2/9/2012 Physician Japan
Primary
Concomitant
Infection Other Serious 8/21/2009 6 Male 35 lb 2/9/2012 Physician Japan
Primary
Concomitant
Haemolytic Anaemia Other Serious 8/21/2009 6 Male 35 lb 2/9/2012 Physician Japan
Primary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 3/6/2009 9 Male 49 lb 2/10/2012 Physician Japan
Primary
Concomitant
Acute Graft Versus Host Disease Other Serious 27 Male 2/23/2012 Physician Japan
Primary
Concomitant
Chronic Graft Versus Host Disease Other Serious 55 Male 2/23/2012 Physician Japan
Primary
Concomitant

Drug Data