Loxonin combined with Methotrexate

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Rheumatoid Arthritis Other Serious 12/25/2003 56 Female 101 lb 1/2/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/12/2005 Female 112 lb 1/6/2006 Physician Japan
Primary
Concomitant
Osteonecrosis Hospitalization 9/1/2004 Male 176 lb 2/6/2006 Physician Japan
Primary
Concomitant
Tuberculous Pleurisy Hospitalization 8/23/2005 Female 2/6/2006 Physician Japan
Primary
Concomitant
Nephrotic Syndrome Hospitalization 10/24/2005 Male 2/10/2006 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 6/29/2005 Male 161 lb 2/10/2006 Physician Japan
Primary
Concomitant
Osteonecrosis Hospitalization 9/1/2004 Male 176 lb 3/9/2006 Physician Japan
Primary
Concomitant
Nephrotic Syndrome Hospitalization 10/24/2005 Male 3/10/2006 Physician Japan
Primary
Concomitant
Bronchitis Acute Hospitalization 12/30/2005 Female 137 lb 3/15/2006 Physician Japan
Primary
Concomitant
Septic Shock Hospitalization 4/1/2005 76 Male 3/18/2006 Pharmacist Japan
Primary
Concomitant
Tuberculous Pleurisy Hospitalization 6/22/2005 Female 4/3/2006 Physician Japan
Primary
Concomitant
Breast Cancer Other Serious 11/1/2005 Female 99 lb 4/7/2006 Physician Japan
Primary
Concomitant
Bronchitis Acute Hospitalization 12/30/2005 Female 137 lb 4/11/2006 Physician Japan
Primary
Secondary
Concomitant
Urticaria Other Serious 11/27/2003 Female 95 lb 4/20/2006 Physician Japan
Primary
Concomitant
B-cell Lymphoma Hospitalization 4/1/2006 Female 106 lb 5/2/2006 Physician Japan
Primary
Secondary
Concomitant
B-cell Lymphoma Stage Iv Life Threatening 3/1/2006 Female 90 lb 5/23/2006 Physician Japan
Primary
Secondary
Concomitant
Anaphylactic Reaction Hospitalization 4/4/2006 Male 134 lb 5/25/2006 Physician Japan
Primary
Concomitant
Breast Cancer Other Serious 12/1/2005 Female 99 lb 5/25/2006 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/12/2005 Female 112 lb 6/12/2006 Physician Japan
Primary
Concomitant
Urticaria Other Serious 5/24/2006 Female 115 lb 7/26/2006 Physician Japan
Primary
Concomitant
Infusion Related Reaction Other Serious 5/24/2006 Female 115 lb 8/16/2006 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 4/12/2006 Male 121 lb 9/18/2006 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 7/3/2006 Female 106 lb 10/11/2006 Physician Japan
Primary
Secondary
Concomitant
Retinal Vein Occlusion Other Serious 12/31/2005 Female 104 lb 11/1/2006 Physician Japan
Primary
Secondary
Concomitant
Tuberculous Pleurisy Hospitalization 6/22/2005 Female 163 lb 11/7/2006 Physician Japan
Primary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 1/23/2004 Female 119 lb 12/14/2006 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 6/12/2005 Female 112 lb 2/7/2007 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 5/24/2005 Female 99 lb 3/12/2007 Japan
Primary
Secondary
Concomitant
Infusion Related Reaction Other Serious 3/12/2007 Female 97 lb 4/10/2007 Physician Japan
Primary
Secondary
Concomitant
Arthritis Bacterial Hospitalization 2/16/2007 Female 104 lb 4/17/2007 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 7/3/2006 Female 106 lb 4/25/2007 Physician Japan
Primary
Secondary
Concomitant
Reflux Oesophagitis Hospitalization 3/4/2007 Female 146 lb 4/25/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 1/28/2006 Female 146 lb 4/25/2007 Physician Japan
Primary
Concomitant
Reflux Oesophagitis Hospitalization 3/4/2007 Female 146 lb 4/30/2007 Physician Japan
Primary
Secondary
Concomitant
Reflux Oesophagitis Hospitalization 3/4/2007 Female 146 lb 5/1/2007 Physician Japan
Primary
Secondary
Concomitant
Upper Respiratory Tract Inflammation Hospitalization 1/23/2004 Female 119 lb 5/1/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 7/3/2006 Female 106 lb 5/16/2007 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 10/22/2003 Male 110 lb 5/25/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 3/4/2007 Female 146 lb 6/11/2007 Physician Japan
Primary
Secondary
Concomitant
Joint Swelling Hospitalization 10/17/2003 Female 97 lb 6/15/2007 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 9/30/2005 63 Female 139 lb 6/15/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 11/1/2005 Female 99 lb 6/19/2007 Physician Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Hospitalization 11/1/2005 Female 99 lb 7/5/2007 Physician Japan
Primary
Secondary
Concomitant
Diffuse Large B-cell Lymphoma Hospitalization 6/4/2006 Female 79 lb 8/2/2007 Physician Japan
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 7/1/2007 Male 132 lb 8/3/2007 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 7/9/2007 Female 132 lb 8/7/2007 Physician Japan
Primary
Concomitant
Renal Failure Acute Other Serious 6/1/2005 66 Male 8/15/2007 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/1/2005 66 Male 8/28/2007 Consumer Japan
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 6/1/2005 66 Male 9/4/2007 Consumer Japan
Primary
Secondary
Concomitant
Sputum Culture Positive Life Threatening 8/14/2007 Male 126 lb 9/11/2007 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/9/2007 Female 132 lb 9/18/2007 Physician Japan
Primary
Concomitant
Respiratory Failure Other Serious 6/27/2005 65 Male 9/21/2007 Consumer Japan
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 6/27/2005 65 Male 10/11/2007 Consumer Japan
Primary
Secondary
Concomitant
Pustular Psoriasis Other Serious 7/1/2006 Female 110 lb 11/12/2007 Physician Japan
Primary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 7/1/2006 Male 132 lb 11/15/2007 Physician Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Life Threatening 8/14/2007 Male 126 lb 11/20/2007 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 11/25/2006 24 Male 95 lb 11/20/2007 Physician Japan
Primary
Concomitant
Pustular Psoriasis Other Serious 7/1/2006 Female 110 lb 11/29/2007 Physician Japan
Primary
Concomitant
Retinal Vein Occlusion Other Serious 12/31/2005 Female 104 lb 12/20/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 2/10/2006 Female 146 lb 12/21/2007 Physician Japan
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 11/1/2007 Female 121 lb 1/22/2008 Physician Japan
Primary
Concomitant
Pustular Psoriasis Other Serious 7/1/2006 Female 110 lb 1/31/2008 Physician Japan
Primary
Concomitant
Infusion Related Reaction 3/12/2007 Female 97 lb 2/11/2008 Physician Japan
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 11/1/2007 Female 121 lb 2/11/2008 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 9/30/2005 Female 139 lb 2/12/2008 Physician Japan
Primary
Secondary
Concomitant
Breast Cancer Life Threatening 10/1/2005 Female 154 lb 3/24/2008 Physician Japan
Primary
Concomitant
Renal Impairment Other Serious 9/30/2005 Female 139 lb 3/25/2008 Physician Japan
Primary
Secondary
Concomitant
Quadriplegia Hospitalization 12/7/2007 Female 126 lb 4/2/2008 Physician Japan
Primary
Concomitant
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
Bronchiectasis Hospitalization 2/7/2008 Male 110 lb 5/19/2008 Physician Japan
Primary
Concomitant
Pustular Psoriasis Other Serious 8/1/2006 Female 110 lb 5/30/2008 Physician Japan
Primary
Concomitant
Pneumonia Life Threatening 4/12/2008 Female 101 lb 6/3/2008 Physician Japan
Primary
Secondary
Concomitant
Peritoneal Tuberculosis Hospitalization 3/29/2008 Female 104 lb 6/10/2008 Physician Japan
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 7/1/2006 Male 132 lb 6/12/2008 Physician Japan
Primary
Concomitant
Peritoneal Tuberculosis Hospitalization 3/29/2008 Female 104 lb 7/2/2008 Physician Japan
Primary
Secondary
Concomitant
Breast Cancer Life Threatening 10/1/2005 Female 154 lb 7/8/2008 Physician Japan
Primary
Concomitant
Pustular Psoriasis Other Serious 8/1/2006 Female 110 lb 7/9/2008 Physician Japan
Primary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 7/15/2008 Physician Japan
Primary
Concomitant
Peritoneal Tuberculosis Hospitalization 3/29/2008 Female 104 lb 7/17/2008 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 5/1/2008 Female 8/27/2008 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 5/1/2008 Female 9/15/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 12/11/2006 Male 9/17/2008 Physician Japan
Primary
Secondary
Concomitant
Cardiomegaly Disability 4/16/2007 46 Female 108 lb 9/19/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 12/11/2006 Male 9/30/2008 Physician Japan
Primary
Secondary
Concomitant
Interstitial Lung Disease Hospitalization 9/1/2007 Female 110 lb 10/23/2008 Physician Japan
Primary
Concomitant
Osteonecrosis Other Serious 58 Female 10/30/2008 Other Health Professional Japan
Primary
Concomitant
Vomiting Hospitalization 7/9/2007 Female 132 lb 11/5/2008 Physician Japan
Primary
Concomitant
Reflux Oesophagitis Hospitalization 3/4/2007 Female 146 lb 11/7/2008 Physician Japan
Primary
Secondary
Concomitant
Skull Fracture Hospitalization 3/16/2005 Female 117 lb 11/11/2008 Japan
Primary
Secondary
Concomitant
Osteonecrosis Other Serious 5/1/2008 58 Female 11/14/2008 Other Health Professional Japan
Primary
Concomitant
Therapeutic Response Decreased Other Serious 5/19/2008 Female 11/24/2008 Physician Japan
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Life Threatening 7/1/2006 Male 132 lb 12/30/2008 Physician Japan
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 7/30/2008 Female 101 lb 12/31/2008 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 5/19/2008 Female 1/26/2009 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 8/7/2006 Male 167 lb 2/13/2009 Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 8/7/2006 Male 167 lb 4/24/2009 Japan
Primary
Concomitant
Peritoneal Tuberculosis Hospitalization 3/29/2008 Female 104 lb 5/1/2009 Physician Japan
Primary
Secondary
Concomitant
B-cell Lymphoma Other Serious 7/1/2008 Male 134 lb 6/9/2009 Physician Japan
Primary
Secondary
Concomitant
B-cell Lymphoma Other Serious 7/1/2008 Male 134 lb 6/18/2009 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 5/19/2008 Female 6/29/2009 Physician Japan
Primary
Secondary
Concomitant
B-cell Lymphoma Hospitalization 1/30/2006 Male 9/15/2009 Japan
Primary
Secondary
Concomitant
Synovial Cyst Life Threatening 8/28/2009 Male 128 lb 9/24/2009 Physician Japan
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 7/24/2008 Female 86 lb 11/20/2009 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 5/6/2008 Male 110 lb 12/30/2009 Japan
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 9/29/2009 Male 106 lb 1/4/2010 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 5/6/2008 Male 110 lb 1/8/2010 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 8/7/2008 Male 117 lb 1/22/2010 Physician Japan
Primary
Secondary
Concomitant
Bronchopneumonia Other Serious 7/6/2009 Female 1/25/2010 Physician Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 5/6/2008 Male 110 lb 1/25/2010 Japan
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 5/6/2008 Male 110 lb 2/1/2010 Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 8/7/2008 Male 117 lb 2/2/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Other Serious 8/7/2008 Male 117 lb 2/11/2010 Physician Japan
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Other Serious 1/20/2010 Female 99 lb 2/11/2010 Physician Japan
Primary
Secondary
Concomitant
Death Other Serious 9/29/2009 Male 106 lb 2/11/2010 Physician Japan
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Other Serious 1/20/2010 Female 99 lb 2/17/2010 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 5/19/2008 Female 2/19/2010 Physician Japan
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 9/5/2008 Female 2/23/2010 Physician Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Life Threatening 6/1/2009 Female 73 lb 3/1/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Other Serious 1/1/2009 Female 3/3/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/2/2008 28 Female 112 lb 3/4/2010 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 Female 86 lb 3/8/2010 Japan
Primary
Concomitant
Gastric Perforation Life Threatening 5/14/2009 Female 95 lb 3/11/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Life Threatening 2/4/2010 Female 119 lb 3/11/2010 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 7/24/2008 Female 86 lb 3/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Life Threatening 2/4/2010 Female 119 lb 3/19/2010 Physician Japan
Primary
Secondary
Concomitant
Uterine Leiomyoma Other Serious 8/7/2009 Female 3/19/2010 Physician Japan
Primary
Secondary
Concomitant
Therapeutic Response Decreased Other Serious 5/19/2008 60 Female 4/2/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Cytomegaloviral Life Threatening 2/4/2010 51 Female 119 lb 4/2/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/2/2008 28 Female 112 lb 4/6/2010 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 69 Female 86 lb 4/9/2010 Japan
Primary
Concomitant
Rash Hospitalization 5/15/2009 58 Female 106 lb 5/6/2010 Physician Japan
Primary
Concomitant
Platelet Count Increased 7/6/2009 77 Female 5/28/2010 Physician Japan
Primary
Secondary
Concomitant
Death Death 5/15/2010 44 Female 134 lb 6/9/2010 Consumer United Kingdom
Primary
Concomitant
Herpes Zoster Hospitalization 4/2/2010 48 Female 88 lb 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 8/7/2008 70 Male 117 lb 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Death Death 5/15/2010 44 Female 134 lb 6/29/2010 Consumer United Kingdom
Primary
Concomitant
Thrombocytopenic Purpura Other Serious 4/28/2010 43 Female 110 lb 7/2/2010 Physician Japan
Primary
Secondary
Concomitant
Menorrhagia Hospitalization 7/21/2007 41 Female 134 lb 7/7/2010 Consumer United Kingdom
Primary
Concomitant
Death Death 5/15/2010 44 Female 134 lb 7/9/2010 Consumer United Kingdom
Primary
Concomitant
Seborrhoeic Dermatitis Hospitalization 3/8/2007 59 Female 7/12/2010 Physician Japan
Primary
Secondary
Concomitant
Thrombocytopenic Purpura Other Serious 4/28/2010 43 Female 110 lb 7/16/2010 Physician Japan
Primary
Secondary
Concomitant
Seborrhoeic Dermatitis Hospitalization 3/8/2007 59 Female 7/19/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Hospitalization 11/11/2008 Male 8/3/2010 United States
Primary
Concomitant
Thrombocytopenic Purpura Other Serious 4/28/2010 43 Female 110 lb 8/20/2010 Physician Japan
Primary
Secondary
Concomitant
Tuberculosis Other Serious 7/24/2006 72 Male 117 lb 8/23/2010 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 8/22/2008 73 Female 90 lb 8/25/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 9/18/2008 31 Female 8/27/2010 Physician Japan
Primary
Secondary
Concomitant
Vertigo Hospitalization 2/27/2010 60 Female 132 lb 8/30/2010 Physician Japan
Primary
Concomitant
Angiosarcoma Death 8/16/2010 77 Female 104 lb 9/7/2010 Physician Japan
Primary
Concomitant