Methotrexate combined with Rebamipide

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Leukoencephalopathy Hospitalization 12/5/2006 70 Female 9/6/2007 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 65 Male 3/6/2008
Primary
Secondary
Concomitant
Pulmonary Mass Hospitalization 8/7/2006 Male 160 lb 6/13/2008 Japan
Primary
Concomitant
Pulmonary Mass Hospitalization 8/7/2006 Male 160 lb 6/27/2008 Japan
Primary
Concomitant
Pulmonary Mass Hospitalization 8/7/2006 Male 160 lb 7/11/2008 Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 8/7/2006 Male 160 lb 8/8/2008 Japan
Primary
Concomitant
Tonsillitis Life Threatening 8/8/2008 Female 109 lb 9/3/2008 Japan
Primary
Concomitant
Tonsillitis Life Threatening 8/8/2008 Female 109 lb 9/8/2008 Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 8/7/2006 Male 160 lb 9/12/2008 Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 8/7/2006 Male 160 lb 10/1/2008 Japan
Primary
Concomitant
Tonsillitis Life Threatening 8/8/2008 Female 109 lb 10/20/2008 Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 8/7/2006 Male 167 lb 11/26/2008 Japan
Primary
Concomitant
Visual Impairment Hospitalization 11/27/2008 Male 110 lb 12/26/2008 United States
Primary
Concomitant
Tonsillitis Life Threatening 8/8/2008 Female 109 lb 2/10/2009 Japan
Primary
Concomitant
Visual Impairment Hospitalization 11/27/2008 Male 110 lb 2/19/2009 Japan
Primary
Concomitant
Peritonitis Hospitalization 2/2/2009 35 Female 93 lb 3/24/2009 Korea, Republic Of
Primary
Concomitant
Tonsillitis Life Threatening 8/8/2008 Female 109 lb 4/8/2009 Japan
Primary
Concomitant
Uveitis Other Serious 11/10/2008 Female 123 lb 6/5/2009 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 3/10/2009 Female 111 lb 6/19/2009 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 11/27/2008 Male 110 lb 6/22/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/11/2009 Female 7/8/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 7/9/2009 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/11/2009 Female 7/10/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 7/15/2009 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 7/20/2009 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/11/2009 Female 7/27/2009 Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 3/24/2009 Female 7/31/2009 Japan
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 5/11/2009 Female 8/4/2009 Japan
Primary
Secondary
Concomitant
Stomatitis Hospitalization 7/15/2009 72 Female 114 lb 8/17/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 7/16/2009 Female 110 lb 9/1/2009 Japan
Primary
Concomitant
Pneumonia Hospitalization 7/16/2009 Female 110 lb 9/3/2009 Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/21/2009 Female 92 lb 9/4/2009 Japan
Primary
Secondary
Concomitant
Splenomegaly Other Serious 7/2/2009 Female 9/4/2009 Japan
Primary
Concomitant
White Blood Cell Count Decreased Hospitalization 3/30/2009 64 Female 112 lb 9/17/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 7/21/2009 Female 92 lb 9/17/2009 Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/1/2009 Female 139 lb 9/18/2009 Japan
Primary
Secondary
Concomitant
Splenomegaly Life Threatening 7/2/2009 Female 9/21/2009 Japan
Primary
Concomitant
Stomatitis Hospitalization 7/15/2009 72 Female 114 lb 9/22/2009 Physician Japan
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 8/5/2009 71 Female 110 lb 10/2/2009 Other Health Professional Korea, Republic Of
Primary
Concomitant
Rheumatoid Lung Hospitalization 5/11/2009 Female 10/22/2009 Japan
Primary
Secondary
Concomitant
Putamen Haemorrhage Hospitalization 8/11/2009 62 Male 10/23/2009 Japan
Primary
Concomitant
Pneumonia Other Serious 11/2/2009 Female 104 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 11/2/2009 Female 104 lb 11/24/2009 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 1/1/2009 71 Female 110 lb 12/2/2009 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Pneumonia Other Serious 11/2/2009 Female 104 lb 12/4/2009 Physician Japan
Primary
Secondary
Concomitant
Rheumatoid Lung Hospitalization 6/3/2009 Female 12/14/2009 Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 8/25/2009 Male 146 lb 12/15/2009 Japan
Primary
Secondary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 8/25/2009 Male 146 lb 12/22/2009 Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Hospitalization 12/8/2009 Female 101 lb 12/23/2009 Japan
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 8/24/2009 Male 146 lb 12/28/2009 Japan
Primary
Secondary
Concomitant
Organising Pneumonia Other Serious 11/2/2009 Female 104 lb 12/31/2009 Physician Japan
Primary
Secondary
Concomitant
Polymyositis Hospitalization 11/5/2009 Female 94 lb 1/14/2010 Japan
Primary
Concomitant
Quadriparesis Hospitalization 1/1/2010 Female 1/15/2010 Physician Japan
Primary
Secondary
Concomitant
Polymyositis Hospitalization 11/5/2009 Female 94 lb 1/19/2010 Japan
Primary
Concomitant
Respiratory Failure Other Serious 9/2/2009 Male 1/20/2010 Japan
Primary
Concomitant
Pain Other Serious 1/6/2010 Female 115 lb 1/28/2010 Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9/2/2009 Female 2/4/2010 Japan
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 1/5/2010 Male 137 lb 2/5/2010 Physician Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 9/2/2009 Female 2/11/2010 Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9/1/2009 Female 2/11/2010 Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 Female 86 lb 2/12/2010 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 11/25/2009 Female 2/15/2010 Japan
Primary
Concomitant
Xanthelasma Life Threatening 1/5/2010 Male 137 lb 2/18/2010 Physician Japan
Primary
Concomitant
H1n1 Influenza Hospitalization 1/28/2010 Female 2/10/2010 Japan
Primary
Concomitant
Xanthelasma Life Threatening 1/5/2010 Male 137 lb 2/23/2010 Physician Japan
Primary
Concomitant
Spinal Column Stenosis Hospitalization 7/9/2009 67 Female 2/24/2010 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 12/11/2009 Female 139 lb 2/24/2010 Physician Japan
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 12/11/2009 Female 139 lb 2/24/2010 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 Female 86 lb 2/25/2010 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 11/25/2009 Female 2/26/2010 Japan
Primary
Concomitant
Pyrexia Other Serious 3/22/2009 15 Male 110 lb 2/26/2010 Physician Japan
Primary
Concomitant
Pain Other Serious 1/6/2010 Female 115 lb 2/26/2010 Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 1/27/2010 Female 2/19/2010 Japan
Primary
Concomitant
Hyponatraemia Hospitalization 12/11/2009 Female 139 lb 3/5/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9/1/2009 Female 3/5/2010 Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 Female 86 lb 3/8/2010 Japan
Primary
Concomitant
Viral Test Positive Hospitalization 1/27/2010 Female 3/5/2010 Japan
Primary
Concomitant
Vomiting Hospitalization 12/18/2009 Female 3/10/2010 Japan
Primary
Concomitant
Dizziness Other Serious 6/7/2009 Female 3/17/2010 Japan
Primary
Concomitant
Spinal Column Stenosis Hospitalization 7/9/2009 67 Female 3/18/2010 Consumer Korea, Republic Of
Primary
Secondary
Concomitant
Nausea Hospitalization 1/27/2010 Female 3/19/2010 Other Health Professional Japan
Primary
Concomitant
Shock Other Serious 1/6/2010 Female 115 lb 3/26/2010 Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Hospitalization 10/13/2009 Female 3/26/2010 Japan
Primary
Concomitant
Suffocation Feeling Hospitalization 10/29/2009 Female 3/26/2010 Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 9/1/2009 Female 3/30/2010 Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 9/1/2009 Female 3/30/2010 Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Hospitalization 10/14/2009 38 Female 4/7/2010 Japan
Primary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 69 Female 86 lb 4/9/2010 Japan
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 12/18/2009 68 Female 4/7/2010 Japan
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Hospitalization 8/11/2009 73 Female 101 lb 4/13/2010 Japan
Primary
Concomitant
Polymyositis Hospitalization 11/5/2009 63 Female 94 lb 4/15/2010 Japan
Primary
Concomitant
Suffocation Feeling Hospitalization 10/29/2009 45 Female 4/21/2010 Japan
Primary
Concomitant
Dermatitis Acneiform Hospitalization 10/14/2009 38 Female 4/22/2010 Japan
Primary
Concomitant
Respiratory Distress Hospitalization 3/18/2010 86 Female 4/27/2010 Japan
Primary
Concomitant
Vomiting Hospitalization 8/10/2009 73 Female 101 lb 4/28/2010 Japan
Primary
Concomitant
Interstitial Lung Disease Hospitalization 3/18/2010 86 Female 4/29/2010 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 3/9/2010 51 Female 117 lb 4/27/2010 Korea, Republic Of
Primary
Concomitant
Pneumonia Pneumococcal Hospitalization 12/18/2009 68 Female 5/10/2010 Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 3/18/2010 86 Female 5/18/2010 Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/10/2009 73 Female 101 lb 5/18/2010 Japan
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 12/18/2009 68 Female 5/19/2010 Japan
Primary
Secondary
Concomitant
Suffocation Feeling Hospitalization 10/29/2009 45 Female 6/3/2010 Physician Japan
Primary
Concomitant
Metrorrhagia Hospitalization 5/19/2010 56 Female 6/1/2010 Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 9/1/2009 75 Female 6/9/2010 Physician Japan
Primary
Secondary
Concomitant
Endometrial Cancer Hospitalization 5/19/2010 56 Female 6/7/2010 Other Health Professional Japan
Primary
Concomitant
Pyrexia Other Serious 12/30/2009 72 Female 95 lb 6/14/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 12/30/2009 72 Female 95 lb 6/15/2010 Physician Japan
Primary
Secondary
Concomitant
Shock Other Serious 1/6/2010 67 Female 115 lb 6/17/2010 Physician Japan
Primary
Secondary
Concomitant
Metrorrhagia Hospitalization 5/19/2010 56 Female 6/11/2010 Japan
Primary
Concomitant
Pyrexia Other Serious 12/30/2009 72 Female 95 lb 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Suffocation Feeling Hospitalization 10/29/2009 45 Female 6/21/2010 Physician Japan
Primary
Concomitant
Ulcer Hospitalization 6/27/2007 63 Female 75 lb 6/25/2010 Physician Japan
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 2/17/2010 68 Male 119 lb 6/28/2010 Physician Japan
Primary
Secondary
Concomitant
Tuberculosis Hospitalization 2/17/2010 68 Male 119 lb 6/30/2010 Physician Japan
Primary
Secondary
Concomitant
Deafness Neurosensory Hospitalization 5/18/2010 61 Female 119 lb 7/2/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 69 Female 86 lb 7/2/2010 Physician Japan
Primary
Concomitant
Polymyositis Hospitalization 11/5/2009 63 Female 94 lb 7/2/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/17/2009 70 Female 92 lb 7/8/2010 Physician Japan
Primary
Secondary
Concomitant
Tumour Necrosis Hospitalization 12/17/2009 67 Female 7/1/2010 Japan
Primary
Concomitant
Endometriosis Hospitalization 5/19/2010 56 Female 7/1/2010 Japan
Primary
Concomitant
Endometriosis Hospitalization 5/19/2010 56 Female 7/1/2010 Japan
Primary
Concomitant
Uterine Leiomyoma Hospitalization 10/7/2009 56 Female 7/6/2010 Japan
Primary
Concomitant
Pemphigoid Other Serious 6/13/2010 63 Female 7/14/2010 Physician Japan
Primary
Concomitant
Deafness Neurosensory Hospitalization 5/18/2010 61 Female 119 lb 7/16/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 9/2/2009 66 Male 7/19/2010 Physician Japan
Primary
Concomitant
Skin Necrosis Hospitalization 2/8/2010 59 Female 110 lb 7/22/2010 Physician Japan
Primary
Concomitant
Ulcer Hospitalization 6/27/2007 63 Female 75 lb 7/27/2010 Physician Japan
Primary
Secondary
Concomitant
Fall Hospitalization 12/17/2009 67 Female 7/29/2010 Japan
Primary
Concomitant
Respiratory Failure Hospitalization 11/25/2009 70 Female 8/5/2010 Physician Japan
Primary
Concomitant
Necrosis Hospitalization 12/17/2009 67 Female 8/6/2010 Other Health Professional Japan
Primary
Concomitant
Uterine Leiomyoma Hospitalization Female 8/10/2010 Japan
Primary
Concomitant
Shock Other Serious 1/6/2010 67 Female 115 lb 8/17/2010 Physician Japan
Primary
Secondary
Concomitant
Polymyositis Hospitalization 11/5/2009 63 Female 94 lb 8/17/2010 Physician Japan
Primary
Concomitant
Tuberculosis Hospitalization 2/17/2010 68 Male 119 lb 8/18/2010 Physician Japan
Primary
Secondary
Concomitant
Spinal Compression Fracture Life Threatening 6/26/2010 64 Female 8/20/2010 Physician Japan
Primary
Concomitant
Urine Output Decreased Other Serious 3/10/2010 72 Female 108 lb 8/25/2010 Physician Japan
Primary
Secondary
Concomitant
Atrioventricular Block Complete Other Serious 7/6/2010 70 Female 106 lb 8/19/2010 Physician Japan
Primary
Concomitant
Spondylitis Other Serious 6/2/2010 64 Female 8/27/2010 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 7/31/2010 51 Female 8/24/2010 Physician Korea, Democratic People's Republic Of
Primary
Concomitant
Tubo-ovarian Abscess Hospitalization 7/31/2010 51 Female 9/2/2010 Other Health Professional Korea, Republic Of
Primary
Concomitant
Tuberculosis Hospitalization 2/17/2010 68 Male 119 lb 9/14/2010 Physician Japan
Primary
Secondary
Concomitant
Skin Necrosis Hospitalization 2/8/2010 59 Female 110 lb 9/15/2010 Physician Japan
Primary
Concomitant
Pelvic Fracture Hospitalization 7/30/2010 62 Female 9/24/2010 Physician Japan
Primary
Secondary
Concomitant
Dermatitis Acneiform Hospitalization 10/13/2009 38 Female 9/28/2010 Physician Japan
Primary
Concomitant
Pancytopenia Hospitalization 7/31/2010 51 Female 100 lb 9/21/2010 Other Health Professional Korea, Republic Of
Primary
Concomitant
Urine Output Decreased Other Serious 3/10/2010 72 Female 108 lb 10/7/2010 Physician Japan
Primary
Secondary
Concomitant
Spondylitis Other Serious 6/2/2010 64 Female 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 1/30/2010 69 Female 86 lb 10/15/2010 Physician Japan
Primary
Concomitant
Colitis Ischaemic Hospitalization 6/8/2010 47 Female 110 lb 10/18/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/13/2010 71 Female 108 lb 10/18/2010 Physician Japan
Primary
Concomitant

Drug Data