Methotrexate combined with Prograf

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Venoocclusive Liver Disease Life Threatening 6/6/2005 2 Male 26 lb 1/3/2006 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Hospitalization 3/1/2005 7 Female 55 lb 12/30/2005 Physician Japan
Primary
Concomitant
Scab Hospitalization 6/21/2004 11 Female 90 lb 12/30/2005 Physician Japan
Primary
Secondary
Ventricular Hypokinesia Life Threatening 8/25/2004 3 Male 31 lb 12/30/2005 Physician Japan
Primary
Secondary
Concomitant
Therapy Non-responder Hospitalization 56 Male 1/27/2006 Physician Germany
Primary
Concomitant
Post Procedural Complication Death 34 Male 2/7/2006 Physician Japan
Primary
Concomitant
Hemiplegia Death 34 Male 2/16/2006 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 1 Female 2/20/2006 Physician Japan
Primary
Secondary
Concomitant
Pseudomonal Sepsis Other Serious 46 Male 2/22/2006 Physician Japan
Primary
Concomitant
Leukoencephalomyelitis Other Serious 11 Male 3/8/2006 Physician Japan
Primary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 5 Male 3/7/2006 Physician Japan
Primary
Concomitant
Serum Ferritin Increased Other Serious 57 Male 3/6/2006 Physician Japan
Primary
Concomitant
Meningitis Pneumococcal Hospitalization 20 Male 3/8/2006 Physician Japan
Primary
Concomitant
Encephalitis Cytomegalovirus Death 3/10/2006 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 4/17/2002 46 Male 143 lb 3/10/2006 Physician Japan
Primary
Concomitant
Meningitis Pneumococcal Other Serious 12/3/2004 20 Male 3/16/2006 Physician Japan
Primary
Concomitant
Leukoencephalomyelitis Other Serious 11 Male 3/16/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 2/19/2005 0 Male 12 lb 3/20/2006 Physician Japan
Primary
Secondary
Concomitant
Serum Ferritin Increased Other Serious 57 Male 3/15/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 1/1/2001 47 Male 3/20/2006 Physician Japan
Primary
Concomitant
Encephalitis Cytomegalovirus Death Male 3/17/2006 Physician Japan
Primary
Concomitant
Mucormycosis Death 12/1/2004 51 Male 3/24/2006 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 61 Male 3/20/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 1/1/2002 42 Female 3/20/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Disability 1/1/2004 60 Female 3/20/2006 Physician Japan
Primary
Concomitant
Hepatitis Fulminant Death 39 Male 3/20/2006 Physician Japan
Primary
Concomitant
Pseudomonal Sepsis Other Serious 4/17/2002 46 Male 143 lb 3/29/2006 Physician Japan
Primary
Concomitant
Post Procedural Complication Death 39 Male 3/30/2006 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization Male 4/3/2006 Japan
Primary
Concomitant
Refractoriness To Platelet Transfusion Hospitalization 2/12/2005 0 Male 12 lb 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Weight Decrease Neonatal Hospitalization 2/12/2005 0 Male 12 lb 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Adenovirus Infection Death 14 Male 4/25/2006 Physician Japan
Primary
Concomitant
Respiratory Failure Death 8/3/2005 43 Male 4/28/2006 Physician Japan
Primary
Concomitant
Refusal Of Treatment By Patient Hospitalization 4/1/2005 31 Male 4/26/2006 Physician Japan
Primary
Secondary
Venoocclusive Liver Disease Hospitalization 2/1/2005 0 Male 5/10/2006 Consumer United States
Primary
Secondary
Concomitant
Therapy Non-responder Other Serious 23 Female 5/12/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Disability 1/1/2004 61 Female 98 lb 5/15/2006 Physician Japan
Primary
Secondary
Concomitant
Respiratory Syncytial Virus Infection Other Serious 5 Male 5/19/2006 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/22/2003 61 Male 95 lb 5/16/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/5/2002 42 Female 112 lb 5/15/2006 Physician Japan
Primary
Secondary
Concomitant
Sepsis Death Female 5/18/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/21/2001 47 Male 148 lb 5/15/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 2/1/2005 0 Male 6/5/2006 Consumer United States
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Death 34 Male 5/23/2006 Physician Japan
Primary
Concomitant
Pneumonia Bacterial Hospitalization 4/1/2005 31 Male 5/23/2006 Physician Japan
Primary
Secondary
Leukoencephalomyelitis Other Serious 11 Male 6/2/2006 Physician Japan
Primary
Concomitant
Streptococcal Infection Hospitalization 6/7/2006 Male 135 lb 6/8/2006 United States
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Disability 1/1/2004 61 Female 98 lb 6/7/2006 Physician Japan
Primary
Secondary
Concomitant
Toxic Induced Encephalopathy Life Threatening 8/3/2005 43 Male 6/8/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/5/2002 42 Female 112 lb 6/7/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Life Threatening 6/21/2001 47 Male 148 lb 6/23/2006 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Other Serious 2/1/2005 0 Male 7/3/2006 Consumer United States
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Death 55 Male 6/20/2006 Physician Japan
Primary
Concomitant
Pruritus Genital Other Serious 35 Female 8/1/2006 Physician Japan
Primary
Concomitant
Transaminases Increased Hospitalization 7/3/2003 35 Female 8/24/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Pneumonia Bacterial Other Serious 35 Female 9/20/2006 Physician Japan
Primary
Concomitant
Sepsis Hospitalization 11/7/2004 41 Female 10/22/2006 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Hospitalization 28 Male 10/6/2006 Physician Japan
Primary
Concomitant
Pneumonia Fungal Death 57 Male 10/6/2006 Physician Japan
Primary
Concomitant
Visual Acuity Reduced Other Serious 2/25/2006 42 Male 165 lb 10/24/2006 Physician Japan
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 69 Male 11/2/2006 Physician Japan
Primary
Concomitant
Pneumonia Hospitalization 9/1/2005 Male 176 lb 11/2/2006 Physician Japan
Primary
Secondary
Concomitant
Encephalopathy Death 53 Female 11/17/2006 Physician Japan
Primary
Concomitant
Stomatitis Other Serious Male 11/27/2006 Physician Japan
Primary
Concomitant
Lymphoproliferative Disorder Death Unknown 12/1/2006 Physician Japan
Primary
Concomitant
Lymphoproliferative Disorder Death 6 Male 12/13/2006 Physician Japan
Primary
Concomitant
Lymphoproliferative Disorder Death 4/13/2006 6 Male 12/21/2006 Physician Japan
Primary
Concomitant
Vomiting 9/9/2006 67 Male 192 lb 10/24/2006 United States
Primary
Concomitant
Pneumonia Bacterial Death 9/15/2005 36 Male 176 lb 1/15/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 9/15/2005 36 Male 176 lb 1/19/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 9/13/2005 36 Male 176 lb 1/30/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/4/2005 29 Male 141 lb 2/5/2007 Physician Japan
Primary
Concomitant
Quadriparesis Other Serious 41 Male 2/28/2007 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Death 2/27/2007 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Death 2/27/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 2/27/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Death 2/27/2007 Physician Japan
Primary
Concomitant
Pneumonia Cytomegaloviral Other Serious 15 Female 2/27/2007 Physician Japan
Primary
Concomitant
Renal Failure Hospitalization 3/1/2007 Female 3/20/2007 Physician Japan
Primary
Secondary
Staphylococcal Sepsis Other Serious 9/7/2005 5 Male 55 lb 3/6/2007 Physician Japan
Primary
Concomitant
Renal Abscess Other Serious 12 Female 3/15/2007 Physician Japan
Primary
Concomitant
Sputum Culture Positive Other Serious 21 Male 3/14/2007 Physician Japan
Primary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 4/5/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 4/12/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 4/18/2007 Physician Japan
Primary
Secondary
Concomitant
Meningitis Bacterial Hospitalization 63 Male 4/7/2007 Physician Japan
Primary
Concomitant
Herpes Zoster Disseminated Death 29 Male 4/17/2007 Physician Japan
Primary
Concomitant
Somnolence Other Serious 54 Male 4/18/2007 Physician Japan
Primary
Concomitant
Stem Cell Transplant Other Serious 3/22/2005 38 Female 123 lb 4/24/2007 Physician Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 3/22/2005 38 Female 123 lb 4/24/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 1/1/2007 Female 132 lb 5/7/2007 Physician Japan
Primary
Secondary
Concomitant
Scedosporium Infection Death 11/1/2001 43 Male 4/24/2007 Physician United States
Primary
Secondary
Concomitant
Sepsis Hospitalization 46 Male 4/24/2007 Physician United States
Primary
Secondary
Hepatorenal Syndrome Hospitalization 1/1/2007 Female 132 lb 5/14/2007 Physician Japan
Primary
Secondary
Concomitant
Transplant Rejection Death 5/16/2006 49 Female 109 lb 4/29/2007 Physician Japan
Primary
Concomitant
Wound Drainage Death 11/1/2001 43 Male 5/9/2007 Physician United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious Male 5/29/2007 Physician Japan
Primary
Concomitant
Rash Other Serious 0 Male 6/5/2007 Physician Japan
Primary
Concomitant
Weight Increased Hospitalization 2/1/2007 Female 132 lb 6/5/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 6/18/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 6/12/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 7/21/2006 54 Male 157 lb 6/12/2007 Physician Japan
Primary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 6/21/2007 Physician Japan
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious Male 6/18/2007 Physician Japan
Primary
Concomitant
Pulmonary Haemorrhage Other Serious 2/28/2007 14 Female 6/20/2007 Other Health Professional Japan
Primary
Concomitant
Infection In An Immunocompromised Host Hospitalization 6/25/2003 1 Male 12 lb 6/22/2007 Physician Japan
Primary
Secondary
Concomitant
Rectal Abscess Other Serious 12/16/2003 52 Male 6/29/2007 Physician United Kingdom
Primary
Concomitant
Rectal Abscess Other Serious 4/28/2003 32 Male 6/29/2007 Physician United Kingdom
Primary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 7/30/2007 Physician Japan
Primary
Secondary
Concomitant
Hepatorenal Syndrome Hospitalization 2/1/2007 Female 132 lb 8/1/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Death 31 Male 7/20/2007 Physician Korea, Republic Of
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 7/21/2006 54 Male 157 lb 7/24/2007 Physician Japan
Primary
Concomitant
Encephalitis Other Serious 13 Male 7/24/2007 Physician Japan
Primary
Concomitant
Vomiting Life Threatening 2/20/2007 43 Female 8/17/2007 Other Health Professional France
Primary
Secondary
Concomitant
Pulmonary Fibrosis Other Serious 9/20/2006 Female 88 lb 8/30/2007 Physician Japan
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 59 Female 8/27/2007 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Other Serious 8/9/2007 73 Male 8/31/2007 Physician Japan
Primary
Secondary
Splenomegaly Other Serious 46 Male 9/5/2007 Physician United States
Primary
Concomitant
Zygomycosis Other Serious 63 Male 9/5/2007 Physician United States
Primary
Concomitant
Interstitial Lung Disease Other Serious 8/17/2007 74 Male 110 lb 9/12/2007 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 8/17/2007 74 Male 110 lb 9/18/2007 Physician Japan
Primary
Secondary
Concomitant
Encephalitis Herpes Other Serious 8/20/2006 44 Male 9/21/2007 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 41 Male 9/26/2007 Physician Japan
Primary
Concomitant
Human Herpesvirus 6 Infection Other Serious 8/20/2006 44 Male 9/21/2007 Physician Japan
Primary
Concomitant
Myocarditis Mycotic Other Serious 57 Male 10/13/2007 Japan
Primary
Concomitant
Human Herpesvirus 6 Infection Other Serious 59 Female 10/2/2007 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Death 8/30/2007 Female 10/9/2007 Physician Japan
Primary
Secondary
Cardiac Failure Other Serious 6/29/2006 2 Male 10/18/2007 Consumer United States
Primary
Secondary
Concomitant
Sinus Tachycardia Other Serious 57 Male 10/24/2007 Japan
Primary
Concomitant
Myocarditis Mycotic Death 57 Male 10/22/2007 Physician Japan
Primary
Concomitant
Status Epilepticus Other Serious 41 Male 10/23/2007 Physician Japan
Primary
Concomitant
Pancytopenia Other Serious 59 Female 10/23/2007 Physician Japan
Primary
Concomitant
Atrioventricular Block Complete Other Serious 9/25/2007 66 Female 10/25/2007 Physician Japan
Primary
Concomitant
Septic Shock Other Serious 68 Female 10/29/2007 Physician Japan
Primary
Concomitant
Speech Disorder Hospitalization 4 Female 11/5/2007 Physician Japan
Primary
Concomitant
Cardiac Tamponade Life Threatening 9/27/2007 50 Female 11/14/2007 Consumer United States
Primary
Concomitant
Interstitial Lung Disease Other Serious 8/17/2007 74 Male 110 lb 11/26/2007 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Other Serious 6/29/2006 2 Male 12/7/2007 Consumer United States
Primary
Secondary
Concomitant
Neurotoxicity Hospitalization 11 Female 12/17/2007 Physician Saudi Arabia
Primary
Secondary
Concomitant
Skin Papilloma Other Serious 17 Male 12/21/2007 Physician Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 11/15/2007 Female 1/7/2008 Physician Japan
Primary
Secondary
Venoocclusive Liver Disease Other Serious 1 12/27/2007 Physician Japan
Primary
Concomitant
Proteinuria Other Serious 3/28/2007 73 Female 86 lb 12/27/2007 Physician Japan
Primary
Concomitant
Pruritus Hospitalization 12 Female 12/31/2007 Physician Japan
Primary
Concomitant
Graft Versus Host Disease Death 41 Male 1/16/2008 Physician Japan
Primary
Concomitant
Encephalitis Viral Other Serious Male 1/17/2008 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 6/22/2005 31 Female 1/15/2008 Physician Japan
Primary
Concomitant
Fungal Infection Death 60 Female 1/16/2008 Physician Japan
Primary
Concomitant
Renal Failure Death 26 Male 1/16/2008 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 9/10/2001 32 Male 1/17/2008 Physician Japan
Primary
Secondary
Concomitant

Drug Data