Methotrexate combined with Sandimmune

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Transplant Rejection Other Serious 6/27/2005 1 Male 19 lb 3/17/2006 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Other Serious 7/1/2005 14 Male 3/21/2006 Japan
Primary
Secondary
Vomiting Hospitalization 1/1/2000 70 Female 146 lb 3/28/2006 Lawyer United States
Primary
Concomitant
Sepsis Other Serious 15 Male 3/30/2006 Japan
Primary
Concomitant
Trichosporon Infection Other Serious 1/1/2004 30 Male 3/29/2006 Japan
Primary
Secondary
Concomitant
Tachyarrhythmia Hospitalization 1/1/2006 Male 150 lb 4/7/2006 Physician Germany
Primary
Concomitant
Vomiting Hospitalization 1/1/2000 70 Female 146 lb 4/10/2006 Physician United States
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 10/1/2005 34 Female 209 lb 4/12/2006 Physician Greece
Primary
Secondary
Concomitant
Weight Increased Hospitalization 1/1/2006 Male 132 lb 4/18/2006 Physician Germany
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 1/1/2006 Male 150 lb 5/5/2006 Physician Germany
Primary
Concomitant
Weight Increased Hospitalization 1/1/2006 Male 132 lb 5/5/2006 Physician Germany
Primary
Concomitant
Weight Increased Hospitalization 1/1/2006 Male 132 lb 5/8/2006 Physician Germany
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 1/1/2006 Male 150 lb 5/8/2006 Physician Germany
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 1/1/2006 Male 150 lb 6/7/2006 Physician Germany
Primary
Concomitant
Weight Increased Hospitalization 1/1/2006 Male 132 lb 6/7/2006 Physician Germany
Primary
Concomitant
Swollen Tongue Life Threatening 5/30/2006 Female 6/30/2006 Other Health Professional Sweden
Primary
Concomitant
Vision Blurred Other Serious Male 7/24/2006 Consumer Germany
Primary
Concomitant
Urticaria Life Threatening 7/14/2004 Female 8/3/2006 Physician Czech Republic
Primary
Concomitant
Transaminases Increased Hospitalization 7/3/2003 35 Female 8/24/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Vision Blurred Other Serious Male 9/23/2006 Consumer Germany
Primary
Concomitant
Sepsis Hospitalization 11/7/2004 41 Female 10/22/2006 Japan
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Hospitalization 5/1/2006 63 Female 12/22/2006 Physician Sweden
Primary
Secondary
Thrombophlebitis Other Serious 1/1/2003 34 Female 1/5/2007 Japan
Primary
Secondary
Concomitant
Orbital Oedema Hospitalization 5/11/2006 65 Male 2/15/2007 Physician Italy
Primary
Concomitant
Orbital Oedema Hospitalization 5/11/2006 Male 2/16/2007 Physician Italy
Primary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 86 lb 2/23/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 11/12/2001 23 Female 2/19/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Other Serious 4/25/2003 46 Male 128 lb 3/5/2007 Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 3/31/2006 22 Male 3/7/2007 Japan
Primary
Concomitant
Rash Other Serious 4/25/2003 46 Male 128 lb 4/3/2007 Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 32 Female 4/10/2007 Japan
Primary
Secondary
Serum Ferritin Increased Other Serious 54 Male 4/17/2007 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Death 1/1/2000 Male 112 lb 5/7/2007 Other Health Professional Finland
Primary
Secondary
Concomitant
Transplant Rejection Death 5/16/2006 49 Female 109 lb 4/29/2007 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 2/25/2007 61 Male 5/25/2007 Consumer France
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/3/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/3/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 13 Female 7/6/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 10 Male 7/6/2007 Japan
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 13 Female 7/6/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 6/27/2006 30 Female 90 lb 7/12/2007 Japan
Primary
Secondary
Concomitant
Parvovirus Infection Death 7 Female 7/14/2007 Physician Greece
Primary
Secondary
Acute Myeloid Leukaemia Recurrent Other Serious 1 Male 19 lb 9/24/2007 Japan
Primary
Secondary
Concomitant
Stem Cell Transplant Other Serious 1 Male 19 lb 9/29/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 6/1/2006 12 Male 10/5/2007 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 11/15/2006 7 Female 10/13/2007 Greece
Primary
Secondary
White Blood Cell Count Decreased Death 11/15/2006 7 Female 10/13/2007 Greece
Primary
Secondary
Stem Cell Transplant Other Serious 7/3/2003 1 Male 19 lb 10/17/2007 Japan
Primary
Secondary
Concomitant
Sinus Tachycardia Other Serious 57 Male 10/24/2007 Japan
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 2/5/2007 46 Female 10/27/2007 Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 5/1/2007 6 Male 1/3/2008 Japan
Primary
Concomitant
Nausea Other Serious 9/26/2007 59 Male 121 lb 2/6/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Death 11/15/2006 7 Female 2/13/2008 Greece
Primary
Secondary
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 2/29/2008 Physician Japan
Primary
Secondary
Concomitant
Rash Other Serious 12/1/2006 56 Male 3/11/2008 Japan
Primary
Secondary
Concomitant
Vasculitis Necrotising Life Threatening 12/26/2007 Male 3/21/2008 Physician Norway
Primary
Concomitant
Venoocclusive Disease Other Serious 54 Male 4/1/2008 Japan
Primary
Secondary
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/17/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Disability 4/16/2007 46 Female 108 lb 4/22/2008 Physician Japan
Primary
Concomitant
Tachycardia Other Serious 24 Female 4/26/2008 Physician Finland
Primary
Concomitant
Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Stage I Other Serious 2/1/2008 47 Female 5/2/2008 Physician Norway
Primary
Secondary
Concomitant
Pneumothorax Other Serious 5/31/2006 54 Male 123 lb 5/9/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 7/15/2008 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/22/2007 Male 97 lb 8/13/2008 Other Health Professional Brazil
Primary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 8/15/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Weight Increased Other Serious 5/16/2008 Female 8/15/2008 Other Health Professional Brazil
Primary
Concomitant
Respiratory Failure Life Threatening 7/27/2008 Female 8/20/2008 Other Health Professional Switzerland
Primary
Secondary
Transplant Rejection Hospitalization 10/20/1995 Male 216 lb 9/2/2008 Physician United States
Primary
Concomitant
Respiratory Distress Other Serious 58 Male 9/8/2008 Other Health Professional Japan
Primary
Secondary
Respiratory Distress Other Serious 58 Male 9/8/2008 Other Health Professional Japan
Primary
Secondary
Herpes Zoster Hospitalization 7/11/2008 65 Male 198 lb 9/18/2008 Physician Spain
Primary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 Physician Japan
Primary
Secondary
Concomitant
Tracheostomy Life Threatening 7/27/2008 Female 9/24/2008 Switzerland
Primary
Secondary
Vomiting Hospitalization 7/22/2007 Male 97 lb 10/10/2008 Other Health Professional Brazil
Primary
Concomitant
Vomiting Other Serious 5/19/2008 Male 52 lb 10/16/2008 Other Health Professional Brazil
Primary
Secondary
Concomitant
Weight Increased Other Serious 5/16/2008 Female 10/16/2008 Other Health Professional Brazil
Primary
Concomitant
Renal Impairment Other Serious 8/3/2007 24 Male 126 lb 10/20/2008 Consumer Japan
Primary
Secondary
Concomitant
Shock Other Serious 11/30/2007 Male 35 lb 11/3/2008 Other Health Professional Brazil
Primary
Concomitant
Visual Acuity Reduced Other Serious 4/18/2008 Male 57 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Vision Blurred Hospitalization 12/14/2007 Male 52 lb 11/4/2008 Other Health Professional Brazil
Primary
Concomitant
Visual Impairment Other Serious 4/21/2008 Male 36 lb 11/4/2008 Pharmacist 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
Weight Increased Other Serious 5/16/2008 Female 166 lb 11/5/2008 Other Health Professional Brazil
Primary
Concomitant
Weight Increased Other Serious 44 Male 11/19/2008 Other Health Professional Japan
Primary
Concomitant
Weight Increased Other Serious 44 Male 11/19/2008 Other Health Professional Japan
Primary
Concomitant
Weight Increased Other Serious 11/26/2007 43 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 11/26/2007 43 Female 11/26/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 12/23/2008 Physician Japan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 10/6/2004 Male 143 lb 1/16/2009 Physician Japan
Primary
Secondary
Concomitant
Polycythaemia Hospitalization 4/9/2008 32 Female 1/26/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 42 Male 172 lb 1/31/2009 Consumer Brazil
Primary
Concomitant
Polycythaemia Hospitalization 4/9/2008 32 Female 2/19/2009 Other Health Professional Sweden
Primary
Secondary
Concomitant
Rash Other Serious 8 Male 2/19/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Tubular Disorder Hospitalization 1/1/1997 56 Male 2/20/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Sacroiliitis Other Serious 11/9/2007 42 Male 3/24/2009 Physician Finland
Primary
Concomitant
Sinusitis Hospitalization 2/26/2008 16 Male 117 lb 4/3/2009 Physician Japan
Primary
Concomitant
Sinusitis Hospitalization 2/26/2008 16 Male 117 lb 4/6/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 6/26/2008 49 4/6/2009 Physician Japan
Primary
Secondary
Concomitant
Splenic Neoplasm Malignancy Unspecified Other Serious 11/24/2005 Male 154 lb 4/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Thirst Other Serious 12/25/2007 49 Female 123 lb 4/3/2009 Physician Japan
Primary
Concomitant
Sinusitis Hospitalization 1/1/2008 16 Male 117 lb 4/14/2009 Physician Japan
Primary
Concomitant
Swollen Tongue Other Serious 1/1/2007 16 Male 4/24/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 6/20/2008 62 Female 108 lb 4/27/2009 Physician Japan
Primary
Concomitant
Sputum Abnormal Other Serious 58 Male 5/4/2009 Other Health Professional Japan
Primary
Secondary
Sepsis Other Serious 9/21/2008 30 Female 117 lb 5/11/2009 Japan
Primary
Concomitant
Sepsis Other Serious 9/21/2008 30 Female 117 lb 5/12/2009 Japan
Primary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/2/2008 56 Male 108 lb 5/18/2009 Japan
Primary
Concomitant
Sepsis Death 9/18/2008 64 Male 117 lb 5/26/2009 Physician Japan
Primary
Concomitant
Visual Impairment Other Serious 12/1/2008 Female 154 lb 5/27/2009 Physician Finland
Primary
Concomitant
Visual Impairment Other Serious 12/1/2008 Female 154 lb 5/28/2009 Physician Finland
Primary
Concomitant
Acute Graft Versus Host Disease In Intestine Other Serious 3/12/2009 61 Male 117 lb 5/29/2009 Physician Japan
Primary
Concomitant
Myelodysplastic Syndrome Other Serious 6/28/2008 65 Male 148 lb 6/1/2009 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Death 1/25/2009 40 Female 6/2/2009 Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/1/2008 57 Male 108 lb 6/5/2009 Japan
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 9/26/2008 46 Male 123 lb 6/5/2009 Physician Jordan
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 9/26/2008 46 Male 123 lb 6/8/2009 Physician Jordan
Primary
Secondary
Concomitant
Reversible Posterior Leukoencephalopathy Syndrome Disability 4/29/2008 58 Male 6/8/2009 Physician Japan
Primary
Secondary
Concomitant
Systemic Mycosis Other Serious 12/9/2008 25 Female 99 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 2/10/2009 39 Male 150 lb 6/9/2009 Japan
Primary
Concomitant
Renal Failure Acute Life Threatening 2/2/2009 60 Male 157 lb 6/12/2009 Japan
Primary
Secondary
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
Weight Increased Other Serious 49 Female 110 lb 7/18/2009 Other Health Professional China
Primary
Concomitant
Platelet Count Decreased Other Serious 8/18/2008 26 Female 117 lb 8/5/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7 Female 8/26/2009 Consumer Brazil
Primary
Concomitant
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/8/2009 Physician Japan
Primary
Secondary
Concomitant
Splenic Neoplasm Malignancy Unspecified Other Serious 6/18/2005 Male 154 lb 9/8/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/11/2009 Physician Japan
Primary
Secondary
Concomitant
Venoocclusive Liver Disease Hospitalization 9/2/2008 56 Male 108 lb 9/15/2009 Japan
Primary
Concomitant
Platelet Count Decreased Other Serious 8/18/2008 26 Female 117 lb 9/15/2009 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 9/21/2008 30 Female 117 lb 9/18/2009 Japan
Primary
Concomitant
Weight Increased Other Serious 12/9/2008 25 Female 99 lb 9/24/2009 Physician Japan
Primary
Secondary
Concomitant
Vomiting Life Threatening 6/20/2008 62 Female 108 lb 9/24/2009 Physician Japan
Primary
Concomitant
Renal Impairment Life Threatening 7/2/2008 49 Male 141 lb 9/25/2009 Physician Japan
Primary
Secondary
Concomitant
Sinusitis Hospitalization 1/1/2008 16 Male 117 lb 9/28/2009 Physician Japan
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 12/25/2007 30 Male 145 lb 10/12/2009 Physician Japan
Primary
Secondary
Concomitant
Urticaria Other Serious 12/9/2008 7 Female 10/15/2009 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7 Female 10/27/2009 Physician Brazil
Primary
Concomitant
Sepsis Life Threatening 9/18/2008 64 Male 117 lb 11/2/2009 Physician Japan
Primary
Concomitant
Skin Ulcer Hospitalization 10/20/2009 36 Female 11/6/2009 Other Health Professional United Kingdom
Primary
Concomitant
Venoocclusive Disease Other Serious 4/1/2002 52 Male 11/19/2009 Japan
Primary
Secondary
Concomitant
Renal Failure Acute Life Threatening 2/2/2009 60 Male 157 lb 11/23/2009 Japan
Primary
Secondary
Concomitant
Acute Graft Versus Host Disease In Skin Other Serious 10/28/2009 56 Female 11/25/2009 Other Health Professional Spain
Primary
Concomitant
Thrombotic Microangiopathy Other Serious 2/11/2009 24 Female 12/4/2009 Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 5/27/2009 65 Male 12/29/2009 Physician Japan
Primary
Concomitant
Interacting

Drug Data