Methotrexate combined with Mycophenolate Mofetil

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Polyneuropathy Other Serious 56 Male 1/19/2006 Germany
Primary
Secondary
Concomitant
Stent Placement Other Serious 33 Female 2/11/2006 Other Health Professional Hong Kong
Primary
Secondary
Transaminases Increased Other Serious 19 Female 3/4/2006 Physician Korea, Republic Of
Primary
Concomitant
Wound Dehiscence Life Threatening 63 Male 3/24/2006 Consumer United Kingdom
Primary
Secondary
White Blood Cell Count Decreased Other Serious 20 Male 4/3/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Treatment Related Secondary Malignancy Other Serious 33 Female 6/6/2006 Other Health Professional China
Primary
Secondary
Skin Lesion Other Serious 33 Female 6/12/2006 Other Health Professional China
Primary
Secondary
Skin Lesion Other Serious 33 Female 6/12/2006 China
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 39 Male 6/23/2006 Other Health Professional United Kingdom
Primary
Concomitant
Pneumonia Fungal Death 7/14/2006 Australia
Primary
Secondary
Concomitant
Bacterial Sepsis Death 7/14/2006 Australia
Primary
Secondary
Concomitant
Bacterial Sepsis Death 7/14/2006 Australia
Primary
Secondary
Concomitant
Bacterial Sepsis Death 7/14/2006 Australia
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 61 Male 7/17/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 61 Male 7/15/2006 Physician United States
Primary
Secondary
Concomitant
B-cell Lymphoma Hospitalization 8/1/2000 46 Female 7/8/2006 Physician United States
Primary
Secondary
Concomitant
Transplant Rejection Other Serious 33 Female 8/4/2006 Hong Kong
Primary
Secondary
Stem Cell Transplant Other Serious 2 Male 8/7/2006 China
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 7/3/2003 35 Female 8/24/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Status Epilepticus Other Serious 7 Female 9/1/2006 Spain
Primary
Concomitant
Trichosporon Infection Death 42 Male 10/9/2006 Japan
Primary
Secondary
Concomitant
Trichosporon Infection Death 42 Male 10/17/2006 Japan
Primary
Secondary
Concomitant
Skin Exfoliation Other Serious 31 Female 10/31/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Tuberculosis Other Serious 39 Male 11/2/2006 Other Health Professional United Kingdom
Primary
Concomitant
Tuberculosis Other Serious 6/1/1994 38 Male 11/15/2006 Other Health Professional Turkey
Primary
Secondary
Concomitant
Partial Seizures Hospitalization 7 Female 1/26/2007 Other Health Professional Spain
Primary
Concomitant
Vasculitis Death 15 Male 2/6/2007 Physician Canada
Primary
Secondary
Concomitant
Status Epilepticus Hospitalization 7 Female 2/9/2007 Other Health Professional Spain
Primary
Concomitant
Vasculitis Death 15 Male 2/12/2007 Physician Canada
Primary
Secondary
Concomitant
Renal Impairment Other Serious 56 Female 2/22/2007 Consumer Finland
Primary
Secondary
Concomitant
Somnolence Other Serious 56 Female 2/23/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Impairment Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
Somnolence Death 56 Female 2/16/2007 Germany
Primary
Secondary
Concomitant
White Blood Cell Count Increased Death 56 Female 2/20/2007 Germany
Primary
Secondary
Concomitant
Somnolence Other Serious 56 Female 3/2/2007
Primary
Secondary
Chronic Graft Versus Host Disease Other Serious 48 Male 3/3/2007 Japan
Primary
Concomitant
Renal Impairment Other Serious 56 Female 2/28/2007 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Other Serious 15 Female 2/27/2007 Physician Japan
Primary
Concomitant
Weight Decreased Other Serious 48 Male 3/10/2007 Japan
Primary
Secondary
Concomitant
Scedosporium Infection Death 11/1/2001 43 Male 4/24/2007 Physician United States
Primary
Secondary
Concomitant
Wound Drainage Death 11/1/2001 43 Male 5/9/2007 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Of Skin Death 61 Male 5/15/2007 Physician United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Death 61 Male 5/29/2007 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Sepsis Life Threatening 4/13/2007 49 Male 7/16/2007 Japan
Primary
Secondary
Concomitant
Paraesthesia Other Serious 41 Female 7/8/2007 Physician United States
Primary
Concomitant
Septic Shock Life Threatening 2/20/2007 Female 8/17/2007 Other Health Professional France
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
Thrombotic Microangiopathy Life Threatening 4/13/2007 49 Male 10/22/2007 Japan
Primary
Secondary
Concomitant
Weight Decreased Other Serious 11/1/2005 34 Female 10/31/2007
Primary
Secondary
Concomitant
Myocarditis Mycotic Death 57 Male 10/22/2007 Physician Japan
Primary
Concomitant
Vasculitis Other Serious 15 Male 11/5/2007 Other Health Professional Canada
Primary
Secondary
Concomitant
Somnolence Other Serious 52 Male 10/31/2007 Physician Japan
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Other Serious 1/1/2004 Male 11/8/2007 Other Health Professional Portugal
Primary
Secondary
Concomitant
Cerebral Toxoplasmosis Other Serious 52 Male 11/16/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 65 Female 11/26/2007 Other Health Professional United States
Primary
Secondary
Somnolence Hospitalization 56 Female 11/15/2007 Germany
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 1/1/2005 65 Female 11/20/2007 Consumer United States
Primary
Secondary
Oral Herpes Other Serious 1/1/2005 65 Female 11/29/2007 Consumer
Primary
Secondary
Toxoplasma Serology Positive Other Serious 2/1/2007 56 Female 12/28/2007 Other Health Professional Germany
Primary
Concomitant
Renal Failure Other Serious 2/22/2008 Other Health Professional United States
Primary
Secondary
Renal Disorder Other Serious 2/29/2008 Other Health Professional United States
Primary
Secondary
Nocardiosis Other Serious Female 3/13/2008 Physician United States
Primary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Male 3/18/2008 Physician Japan
Primary
Concomitant
Protein-losing Gastroenteropathy Other Serious 17 Male 3/11/2008 Physician Japan
Primary
Concomitant
Transplant Rejection Hospitalization 32 Male 3/21/2008 Physician Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 12 Male 3/27/2008 Japan
Primary
Concomitant
Subcutaneous Nodule Other Serious 4 Female 4/3/2008 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 12 Male 4/7/2008 Japan
Primary
Concomitant
Ureteral Stent Insertion Hospitalization 7/9/2007 56 Male 4/2/2008 Japan
Primary
Secondary
Concomitant
Syncope Other Serious 12/1/1997 Male 4/14/2008
Primary
Secondary
Wegener's Granulomatosis Other Serious 12/1/1997 Male 4/15/2008
Primary
Secondary
Acute Myeloid Leukaemia Hospitalization 65 Female 6/3/2008 Korea, Republic Of
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 6/5/2008 Germany
Primary
Secondary
Concomitant
Streptococcal Sepsis Other Serious 6/9/2008 Germany
Primary
Secondary
Concomitant
Transplant Rejection Hospitalization 32 Male 6/10/2008 Physician Japan
Primary
Concomitant
Infection Death 6/26/2008 Spain
Primary
Secondary
Concomitant
Thrombosis Other Serious 53 Male 7/16/2008 Other Health Professional Portugal
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 28 Female 8/1/2008 Other Health Professional Mexico
Primary
Secondary
Pulmonary Haemorrhage Hospitalization 28 Female 8/7/2008 Other Health Professional Mexico
Primary
Secondary
Pulmonary Haemorrhage Hospitalization 28 Female 8/7/2008 Physician United Kingdom
Primary
Secondary
Uveitis Other Serious 9/1/2006 9 Male 8/27/2008 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Death 48 Female 9/9/2008 Other Health Professional Spain
Primary
Secondary
Post Transplant Distal Limb Syndrome Other Serious 18 Male 10/20/2008 Other Health Professional Japan
Primary
Concomitant
Respiratory Failure Other Serious 1/1/2007 37 Male 10/29/2008 Other Health Professional India
Primary
Secondary
Concomitant
Skin Nodule Other Serious 1/1/2006 36 Female 12/1/2008 Other Health Professional Germany
Primary
Concomitant
Glomerulonephritis Rapidly Progressive Other Serious 54 Female 249 lb 12/12/2008
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 0 Male 12/15/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Adenoviral Other Serious 32 Male 12/19/2008 Physician United States
Primary
Secondary
Wegener's Granulomatosis Other Serious 32 Male 12/23/2008 Physician United Kingdom
Primary
Secondary
Serum Sickness Other Serious 30 Female 1/27/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Other Serious 10/1/2004 1/29/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sclerema Other Serious 10/1/2004 2/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Stenotrophomonas Infection Other Serious Male 2/9/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Paraesthesia Other Serious 39 Female 2/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Nasal Neoplasm Benign Other Serious 6/12/2006 64 Male 207 lb 2/18/2009 Other Health Professional United Kingdom
Primary
Concomitant
Sclerema Other Serious 10/1/2004 2/18/2009 Physician Japan
Primary
Secondary
Concomitant
Nasal Neoplasm Benign Other Serious 6/12/2006 64 Male 207 lb 2/19/2009 Other Health Professional United Kingdom
Primary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 3/6/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Death 43 Female 3/3/2009 Japan
Primary
Secondary
Concomitant
Colitis Other Serious 60 Female 3/10/2009 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Haemorrhage Intracranial Other Serious 42 Male 3/13/2009 Other Health Professional China
Primary
Concomitant
Interstitial Lung Disease Death 49 Female 3/13/2009 Other Health Professional China
Primary
Concomitant
Pancytopenia Other Serious 20 Male 3/13/2009 Other Health Professional China
Primary
Concomitant
Acute Graft Versus Host Disease Death 24 Female 3/13/2009 Other Health Professional China
Primary
Concomitant
Leukaemia Recurrent Other Serious 38 Male 3/17/2009 Other Health Professional China
Primary
Concomitant
Engraft Failure Other Serious 42 Male 3/17/2009 Other Health Professional China
Primary
Concomitant
Pancytopenia Other Serious 23 Male 3/17/2009 Other Health Professional China
Primary
Concomitant
Varicella Other Serious 20 Female 3/12/2009 Other Health Professional United States
Primary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Male 3/24/2009 Japan
Primary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/3/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 1/1/2003 11 Female 4/4/2009 Japan
Primary
Concomitant
Immune System Disorder Other Serious 1/1/2008 43 Female 101 lb 4/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Immune System Disorder Death 1/15/2008 43 Female 101 lb 4/22/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 57 Female 110 lb 4/17/2009 Physician Japan
Primary
Secondary
Concomitant
Progressive Multifocal Leukoencephalopathy Death 1/1/2005 57 Female 4/23/2009 Sweden
Primary
Secondary
Systemic Lupus Erythematosus Death 57 Female 5/11/2009 Other Health Professional Sweden
Primary
Secondary
Systemic Mycosis Hospitalization 7/1/2006 50 Female 5/29/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Subcutaneous Abscess Other Serious 76 Male 6/26/2009 Physician France
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 6/29/2009 Physician United States
Primary
Secondary
Concomitant
Subcutaneous Abscess Other Serious 76 Male 6/30/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Intolerance Hospitalization 6/14/2009 25 7/1/2009 Physician Germany
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 7/2/2009 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 17 Male 7/2/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Tuberculosis Other Serious 12/1/2007 19 Male 7/3/2009 Other Health Professional Brazil
Primary
Secondary
Concomitant
Tuberculosis Other Serious 12/1/2007 19 Male 7/7/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Uveitis Other Serious 9 Male 7/8/2009 Physician United States
Primary
Secondary
Weight Increased Other Serious 49 Female 110 lb 7/18/2009 Other Health Professional China
Primary
Concomitant
Systemic Inflammatory Response Syndrome Other Serious 40 Female 9/9/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Sudden Death Death 59 9/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Respiratory Failure Death 7 Male 9/28/2009 Other Health Professional United Kingdom
Primary
Secondary
Transplant Rejection Other Serious 1/1/2007 30 Female 9/28/2009
Primary
Secondary
Concomitant
Respiratory Failure Death 7 Male 10/1/2009 Consumer United Kingdom
Primary
Secondary
Sudden Death Death 59 10/1/2009 Consumer United Kingdom
Primary
Secondary
Vasculitis Other Serious 52 Male 220 lb 10/5/2009
Primary
Secondary
Concomitant
Sepsis Other Serious 10/5/2009 Consumer United Kingdom
Primary
Secondary
Ulcer Haemorrhage Other Serious 29 Male 10/14/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Precursor T-lymphoblastic Lymphoma/leukaemia Other Serious 1/1/2009 12 Male 10/23/2009 Other Health Professional Japan
Primary
Concomitant
Pyrexia Death 12 Male 10/23/2009 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 58 Male 10/27/2009 Physician Japan
Primary
Concomitant
Drug Intolerance Hospitalization 6/14/2009 25 Male 11/9/2009 Physician Germany
Primary
Secondary
Concomitant
Macular Oedema Other Serious 10 Female 11/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Ineffective For Unapproved Indication Other Serious 5 Female 11/23/2009 Other Health Professional United Kingdom
Primary
Concomitant
Systemic Mycosis Hospitalization 7/1/2006 50 Female 11/24/2009 Other Health Professional Italy
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 29 Male 12/1/2009 Other Health Professional United States
Primary
Secondary
Precursor T-lymphoblastic Lymphoma/leukaemia Other Serious 2/1/2009 12 Male 12/2/2009 Other Health Professional Japan
Primary
Concomitant
Infusion Related Reaction Other Serious 7 Male 12/14/2009 Physician Italy
Primary
Concomitant
Metastatic Malignant Melanoma Other Serious 10/1/2006 65 Male 12/29/2009 United States
Primary
Secondary
Systemic Mycosis Hospitalization 7/1/2006 50 Female 12/23/2009 Physician Italy
Primary
Secondary

Drug Data