Ciclosporin combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Thrombotic Microangiopathy Other Serious 8/10/2007 30 Female 9/20/2007 Other Health Professional Japan
Primary
Concomitant
White Blood Cell Count Increased Other Serious 44 Male 10/5/2007 Other Health Professional Japan
Primary
Secondary
Vision Blurred Other Serious 1/1/2005 Female 132 lb 10/12/2007 United States
Primary
Secondary
Concomitant
Myocarditis Mycotic Other Serious 57 Male 10/13/2007 Japan
Primary
Concomitant
Renal Failure Acute Other Serious 28 Male 10/15/2007 Consumer Switzerland
Primary
Secondary
Skin Lesion Hospitalization 5/1/2006 34 Female 10/15/2007 Physician Switzerland
Primary
Concomitant
Ureaplasma Infection Other Serious 28 Male 10/15/2007 Switzerland
Primary
Secondary
Concomitant
Immunosuppression Other Serious 4/19/2007 7 Female 10/16/2007 Consumer Greece
Primary
Secondary
Concomitant
Rash Other Serious 56 Male 3/9/2008 Japan
Primary
Secondary
Concomitant
Nausea Other Serious 10/27/2008 58 Female 106 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
Splenomegaly Other Serious 23 Male 7/12/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Spinal Osteoarthritis Other Serious 3/11/2010 64 Male 121 lb 7/12/2010 Physician Japan
Primary
Concomitant
Testicular Swelling Other Serious 22 Male 7/13/2010 Other Health Professional Iran (Islamic Republic Of)
Primary
Secondary
Concomitant
Transplant Failure Other Serious 7/19/2010 Other Health Professional United Kingdom
Primary
Concomitant
Pyrexia Other Serious 2/16/2009 23 Male 161 lb 7/20/2010 Other Health Professional Japan
Primary
Concomitant
Visual Impairment Other Serious 3/11/2009 49 Female 84 lb 7/21/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Pustular Hospitalization 65 Male 9/21/2010 Consumer India
Primary
Concomitant
Rash Pustular Hospitalization 65 Male 9/29/2010 Other Health Professional India
Primary
Concomitant
Acute Respiratory Distress Syndrome Other Serious 2 Male 2/23/2011 Physician United States
Primary
Concomitant
Acute Respiratory Distress Syndrome Other Serious 5 Male 2/23/2011 Physician United States
Primary
Concomitant
Venoocclusive Liver Disease Other Serious 8/3/2010 1 Male 24 lb 2/28/2011 Physician Japan
Primary
Secondary
Concomitant
Respiratory Distress Life Threatening 9/26/2010 28 Female 3/1/2011 Physician Australia
Primary
Secondary
Concomitant
Autoimmune Thrombocytopenia Death 3/2/2011 Physician Mexico
Primary
Secondary
Concomitant
Systemic Mycosis Hospitalization 4/22/2007 41 Male 132 lb 3/2/2011 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 6/18/2009 42 Female 99 lb 3/9/2011 Physician Japan
Primary
Secondary
Concomitant
Deep Vein Thrombosis Death 1/1/2010 61 Female 3/11/2011 Physician Netherlands
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Life Threatening 1/24/2005 50 Male 121 lb 3/11/2011 Physician Japan
Primary
Secondary
Concomitant
Gamma-glutamyltransferase Increased Life Threatening 11/7/2008 59 Male 148 lb 3/11/2011 Physician Japan
Primary
Concomitant
Ecchymosis Hospitalization 3/1/2005 42 Female 4/15/2011 Other Health Professional Brazil
Primary
Secondary
Concomitant
Pyrexia Other Serious 2/16/2009 24 Male 161 lb 12/18/2012 Other Health Professional Jp
Primary
Concomitant
Viral Haemorrhagic Cystitis Other Serious 8/17/2010 16 Female 121 lb 1/15/2013 Physician Jp
Primary
Secondary
Concomitant
Stomatitis Life Threatening 9/27/2010 60 Male 151 lb 9/12/2012 Physician Jp
Primary
Concomitant
Systemic Candida Life Threatening 5/9/2010 73 Male 119 lb 12/6/2012 Physician Jp
Primary
Secondary
Concomitant
Pyrexia Life Threatening 5/29/2011 15 Female 93 lb 9/13/2012 Physician Jp
Primary
Secondary
Concomitant
Sepsis Other Serious 10/12/2010 6 Female 62 lb 12/21/2012 Physician Jp
Primary
Concomitant
Renal Tubular Disorder Other Serious 4/6/2011 13 Male 97 lb 12/27/2012 Physician Jp
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 9/22/2011 20 Female 106 lb 10/1/2012 Physician Jp
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 7 Male 9/5/2012 Other Health Professional Jp
Primary
Concomitant
Off Label Use Death 9/12/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Venoocclusive Disease Death 9/13/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Wernicke's Encephalopathy Other Serious 12 Male 9/4/2012 Other Health Professional Kr
Primary
Concomitant
Off Label Use Death 9/13/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Viral Infection Other Serious 1 Male 9/5/2012 Other Health Professional Hk
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Death 9/6/2012 Other Health Professional De
Primary
Secondary
Septic Shock Hospitalization 4/8/2012 35 Male 168 lb 11/1/2012 Physician Jp
Primary
Secondary
Concomitant
Myelodysplastic Syndrome Death 9/6/2012 Other Health Professional De
Primary
Secondary
Refractory Cytopenia With Unilineage Dysplasia Death 9/6/2012 Other Health Professional De
Primary
Secondary
Periportal Oedema Death 59 Female 9/6/2012 Physician Il
Primary
Secondary
Acute Graft Versus Host Disease In Intestine Death 41 Male 9/6/2012 Physician Il
Primary
Secondary
Drug Ineffective Death 48 Male 9/7/2012 Physician Il
Primary
Secondary
Renal Tubular Necrosis Death 29 Male 9/7/2012 Other Health Professional Jp
Primary
Concomitant
Non-hodgkin's Lymphoma Recurrent Death 24 Female 9/7/2012 Physician Il
Primary
Secondary
Head Injury Death 9/7/2012 Physician Il
Primary
Secondary
Venoocclusive Disease Death 9/7/2012 Other Health Professional Ie
Primary
Secondary
Concomitant
Vomiting Other Serious 18 Male 9/7/2012 Other Health Professional Br
Primary
Secondary
Concomitant
Ascites Other Serious 34 Male 9/7/2012 Physician Il
Primary
Secondary
Natural Killer Cell Count Increased Other Serious 46 Male 9/10/2012 Other Health Professional Ch
Primary
Secondary
Natural Killer Cell Count Increased Other Serious 37 Male 9/11/2012 Other Health Professional Ch
Primary
Secondary
Natural Killer Cell Count Increased Other Serious 37 Female 9/11/2012 Other Health Professional Ch
Primary
Secondary
Natural Killer Cell Count Increased Other Serious 37 Female 9/11/2012 Other Health Professional Ch
Primary
Secondary
Natural Killer Cell Count Increased Other Serious 25 Female 9/11/2012 Other Health Professional Ch
Primary
Secondary
Sepsis Death 2 9/12/2012 Other Health Professional It
Primary
Secondary
Multi-organ Failure Death 10/1/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Leukaemia Recurrent Death 10/1/2012 Other Health Professional Cn
Primary
Concomitant
Graft Versus Host Disease Death 38 Male 9/13/2012 Other Health Professional Kr
Primary
Secondary
Concomitant
Graft Versus Host Disease Other Serious 41 Male 9/13/2012 Other Health Professional Kr
Primary
Secondary
Concomitant
Graft Versus Host Disease Death 39 Female 9/13/2012 Other Health Professional Kr
Primary
Secondary
Concomitant
Psychiatric Symptom Other Serious 9/2012 51 Male 9/18/2012 Physician Gb
Primary
Concomitant
Graft Versus Host Disease Death 9/21/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Post Transplant Lymphoproliferative Disorder Death 9/21/2012 Other Health Professional Ca
Primary
Secondary
Concomitant
Venoocclusive Disease Other Serious 9/25/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Sepsis Other Serious 1 9/25/2012 Other Health Professional Gb
Primary
Secondary
Concomitant
Neutropenia Other Serious 9/25/2012 Other Health Professional Gb
Primary
Secondary
Transplant Rejection Death 3 Male 9/27/2012 Other Health Professional Us
Primary
Secondary
Concomitant
Pulmonary Fibrosis Other Serious 9/28/2012 Other Health Professional Cn
Primary
Concomitant
Swelling Face Other Serious 2 Female 9/26/2012 Physician Jp
Primary
Secondary
Concomitant
Hepatic Vein Occlusion Other Serious 10/4/2012 Other Health Professional Cn
Primary
Concomitant
Epilepsy Other Serious 10/1/2012 Other Health Professional Cn
Primary
Concomitant
Renal Failure Acute Death 10/10/2012 Other Health Professional Cn
Primary
Concomitant
Renal Failure Acute Death 10/12/2012 Other Health Professional Cn
Primary
Concomitant
Toxicity To Various Agents Death 10/12/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Pneumonia Viral Death 10/12/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Chronic Graft Versus Host Disease Death 10/12/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Death 7 Male 10/12/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Leukoencephalopathy Death 10/16/2012 Other Health Professional Cn
Primary
Concomitant
Interstitial Lung Disease Death 10/16/2012 Other Health Professional Cn
Primary
Concomitant
Infection Death 10/16/2012 Other Health Professional Cn
Primary
Concomitant
Transaminases Increased Other Serious 33 Male 10/16/2012 Other Health Professional Cn
Primary
Concomitant
Septic Shock Death 67 Female 10/22/2012 Physician Jp
Primary
Concomitant
Organ Failure Death 30 Male 10/17/2012 Other Health Professional Cn
Primary
Concomitant
Interstitial Lung Disease Other Serious 9 Male 64 lb 10/17/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Interstitial Lung Disease Other Serious 6 Male 49 lb 10/17/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Thalassaemia Beta Other Serious 7 Male 49 lb 10/17/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Septic Shock Other Serious Female 1/8/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Cystitis Haemorrhagic Other Serious 24 Male 10/19/2012 Other Health Professional Cn
Primary
Concomitant
Graft Versus Host Disease In Skin Other Serious 24 Male 10/19/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 30 Male 10/19/2012 Other Health Professional Es
Primary
Concomitant
Engraft Failure Other Serious 10/19/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Complications Of Bone Marrow Transplant Death 10/22/2012 Other Health Professional Sa
Primary
Concomitant
Death Death 33 Female 10/24/2012 Other Health Professional Cn
Primary
Concomitant
Disseminated Intravascular Coagulation Death 10/25/2012 Other Health Professional De
Primary
Concomitant
Transplant Rejection Other Serious 29 Male 10/23/2012 Other Health Professional Cn
Primary
Secondary
Concomitant
Immunosuppressant Drug Level Increased Other Serious 10/29/2012 Other Health Professional De
Primary
Concomitant
Interacting
Graft Dysfunction Death 10/23/2012 Other Health Professional Fr
Primary
Secondary
Tuberculosis Death 20 Female 10/23/2012 Other Health Professional Cn
Primary
Concomitant
Haemorrhage Death 10/23/2012 Other Health Professional Fr
Primary
Secondary
Acute Respiratory Distress Syndrome Death 10/23/2012 Other Health Professional Fr
Primary
Secondary
Interstitial Lung Disease Death 10/23/2012 Other Health Professional Fr
Primary
Secondary
Interstitial Lung Disease Death 43 Male 10/23/2012 Other Health Professional Cn
Primary
Concomitant
Staphylococcus Test Positive Other Serious 3/2011 27 Male 11/2/2012 Other Health Professional Pl
Primary
Concomitant
Rheumatoid Arthritis Other Serious Female 11/5/2012 Consumer Gb
Primary
Concomitant
Venoocclusive Disease Hospitalization 1/25/2011 3 Male 35 lb 10/10/2012 Gb
Primary
Secondary
Concomitant
Varices Oesophageal Other Serious 51 Female 11/6/2012 Other Health Professional Jp
Primary
Secondary
Neoplasm Malignant Other Serious 11/9/2012 Other Health Professional Jp
Primary
Concomitant
Death Death 11/11/2012 Other Health Professional Cn
Primary
Concomitant
Venoocclusive Disease Death 11/11/2012 Other Health Professional Cn
Primary
Concomitant
Nail Dystrophy Other Serious 4/2011 47 Female 11/12/2012 Other Health Professional Es
Primary
Concomitant
Venoocclusive Disease Death 11/11/2012 Other Health Professional Cn
Primary
Concomitant
Infection Death 11/11/2012 Other Health Professional Cn
Primary
Concomitant
Infection Death 11/11/2012 Other Health Professional Cn
Primary
Concomitant
Febrile Neutropenia Other Serious 12 Male 11/19/2012 Other Health Professional Ru
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 1992 Male 12/3/2012 Consumer Nz
Primary
Concomitant
Pyrexia Other Serious 4/2011 47 Male 12/6/2012 Other Health Professional It
Primary
Secondary
Pulmonary Mycosis Death 15 Male 12/12/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Pustular Psoriasis Disability 10/2010 47 Female 12/21/2012 Other Health Professional Es
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 39 Female 12/26/2012 Other Health Professional It
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Other Serious 45 Female 12/26/2012 Other Health Professional It
Primary
Secondary
Concomitant
Pustular Psoriasis Other Serious 10/2010 47 Female 12/27/2012 Other Health Professional Es
Primary
Secondary
Concomitant
Hodgkin's Disease Other Serious 52 Male 1/2/2013 Other Health Professional Fr
Primary
Secondary
Concomitant
Zygomycosis Hospitalization 32 Male 1/4/2013 Other Health Professional It
Primary
Secondary
Concomitant
Metastases To Bone Disability 11/2012 51 Female 1/2/2013 Physician Gb
Primary
Secondary
Concomitant
Metastases To Bone Disability 2011 51 Female 1/2/2013 Physician Gb
Primary
Secondary
Concomitant
Septic Shock Death 67 Female 1/2/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Spondylitis Other Serious 48 Male 1/10/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Other Serious 52 Male 1/10/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 47 Male 1/11/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Viral Haemorrhagic Cystitis Hospitalization 39 Male 1/11/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 58 Female 1/10/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Septic Shock Death 67 Female 1/9/2013 Other Health Professional Jp
Primary
Secondary
Concomitant
Hepatocellular Injury Other Serious 7/18/2008 39 Female 1/28/2013 Consumer Us
Primary
Secondary
Hepatocellular Injury Other Serious 7/18/2008 39 Female 1/30/2013 Other Health Professional Fr
Primary
Secondary
Graft Versus Host Disease In Skin Other Serious Female 3/27/2013 Other Health Professional Jp
Primary
Secondary
Pustular Psoriasis Other Serious 2007 47 Female 2/4/2013 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Urinary Tract Pain Hospitalization 10/4/2012 10 Male 73 lb 3/13/2013 Physician Jp
Primary
Secondary
Concomitant
Toxicity To Various Agents Other Serious 10 Male 3/2/2013 Other Health Professional Lb
Primary
Concomitant
Pancytopenia Other Serious 2008 77 Male 2/14/2013 Other Health Professional Ch
Primary
Concomitant
Pneumonia Death 6/26/2012 44 Male 2/28/2013 Other Health Professional Es
Primary
Secondary
Concomitant
Pyrexia Hospitalization 7/28/2012 2 Male 24 lb 3/28/2013 Physician Jp
Primary
Secondary
Concomitant
Sepsis Other Serious 5 Male 3/13/2013 Physician Jp
Primary
Secondary
Concomitant
Thrombotic Microangiopathy Other Serious 27 Female 12/5/2012 Other Health Professional Us
Primary
Secondary

Drug Data