Methotrexate combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Fibrocystic Breast Disease Other Serious 11/11/2005 Female 116 lb 1/3/2006 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Varicella Hospitalization 12/7/2005 11 Male 1/13/2006 Other Health Professional Brazil
Primary
Secondary
Concomitant
Varicella Hospitalization 12/7/2005 11 Male 2/28/2006 Other Health Professional Brazil
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 5/24/2005 64 Male 2/22/2006 Other Health Professional Peru
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 12/14/2005 58 Female 138 lb 3/3/2006 Physician China
Primary
Secondary
Varicella Hospitalization 12/7/2005 11 Male 3/16/2006 Other Health Professional Brazil
Primary
Secondary
Concomitant
Appendicitis Hospitalization 4/25/2006 Female 139 lb 5/9/2006 Physician Canada
Primary
Secondary
Concomitant
Respiratory Arrest Death 5/24/2006 Female 152 lb 6/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Tuberculosis Death 10/18/2002 Female 7/14/2006 Other Health Professional United Kingdom
Primary
Concomitant
Therapy Non-responder Life Threatening 5/24/2005 64 Male 7/11/2006 Other Health Professional Peru
Primary
Secondary
Concomitant
Bacterial Infection Hospitalization 6/21/2005 57 Female 7/13/2006 Other Health Professional Zaire
Primary
Secondary
Concomitant
Rectal Cancer Other Serious 7/13/2005 51 Female 8/7/2006 Other Health Professional Brazil
Primary
Secondary
Concomitant
Bacterial Infection Hospitalization 6/21/2005 57 Female 8/7/2006 Other Health Professional Zaire
Primary
Secondary
Concomitant
Respiratory Arrest Death 5/24/2006 Female 152 lb 6/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 1/20/2005 Female 8/31/2006 Physician Argentina
Primary
Secondary
Concomitant
Small Intestinal Obstruction Death Male 143 lb 9/27/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 1/20/2005 Female 10/19/2006 Physician Argentina
Primary
Secondary
Concomitant
Sarcoidosis Life Threatening 6/9/2004 Female 147 lb 11/22/2006 Physician United States
Primary
Concomitant
Pneumonia Hospitalization 11/1/2006 Male 12/8/2006 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Death 8/5/2003 Female 99 lb 7/2/2007 Other Health Professional Denmark
Primary
Secondary
Concomitant
Abdominal Pain Hospitalization 6/18/2007 Male 108 lb 7/2/2007 Physician Canada
Primary
Secondary
Concomitant
Rash Maculo-papular Hospitalization 12/4/2004 Female 132 lb 7/25/2007 Other Health Professional Belgium
Primary
Secondary
Concomitant
Vascular Pseudoaneurysm Hospitalization 10/29/2004 Female 117 lb 8/14/2007 Physician France
Primary
Secondary
Concomitant
Fistula Other Serious 3/1/2007 Male 163 lb 8/14/2007 Physician Canada
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 11/19/2007 Female 183 lb 11/30/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 10/31/2007 Female 183 lb 12/12/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Other Serious 1/7/2007 Female 172 lb 1/18/2008 Physician Canada
Primary
Secondary
Concomitant
Crohn's Disease Hospitalization 2/8/2008 Female 162 lb 2/22/2008 Other Health Professional Canada
Primary
Secondary
Gastric Cancer Other Serious 9/24/2005 Male 143 lb 2/27/2008 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Thoracic Vertebral Fracture Hospitalization 1/3/2008 83 Female 4/8/2008 Physician Belgium
Primary
Concomitant
Tuberculosis Other Serious 2/20/2002 Male 5/9/2008 Physician Germany
Primary
Secondary
Concomitant
Tendonitis Other Serious 2/1/2002 Female 6/13/2008 Other Health Professional Austria
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/24/2007 60 Female 190 lb 9/12/2008 Other Health Professional Finland
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 2/23/2009 33 Female 3/11/2009 Other Health Professional South Africa
Primary
Secondary
Concomitant
Intervertebral Discitis Hospitalization 3/23/2009 Female 159 lb 4/29/2009 Physician Argentina
Primary
Secondary
Concomitant
Gastrointestinal Neoplasm Hospitalization 3/2/2009 Female 157 lb 5/1/2009 Physician Argentina
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 5/6/2009 Physician Mexico
Primary
Secondary
Concomitant
Cellulitis Hospitalization 3/24/2009 Female 192 lb 5/6/2009 Physician Chile
Primary
Secondary
Concomitant
Bladder Cancer Other Serious 5/15/2008 Female 154 lb 5/6/2009 Physician Hungary
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 5/14/2009 Physician Mexico
Primary
Secondary
Concomitant
Bladder Cancer Hospitalization 5/15/2008 Female 154 lb 5/14/2009 Physician Hungary
Primary
Secondary
Concomitant
Gastrointestinal Neoplasm Other Serious 3/2/2009 Female 157 lb 5/15/2009 Physician Argentina
Primary
Secondary
Concomitant
Adenocarcinoma Hospitalization 11/22/2008 Male 192 lb 5/15/2009 Physician Belgium
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/3/2009 Male 5/15/2009 Physician Australia
Primary
Secondary
Concomitant
Mycobacterium Kansasii Infection 8/1/2008 Male 152 lb 5/19/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/10/2009 Male 176 lb 5/20/2009 Physician Australia
Primary
Secondary
Concomitant
Sepsis Hospitalization 5/6/2009 Female 196 lb 5/22/2009 Physician United States
Primary
Secondary
Concomitant
Endometriosis Other Serious 4/14/2009 Female 157 lb 5/29/2009 Physician Argentina
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 10/1/2008 Female 202 lb 5/29/2009 Physician Australia
Primary
Secondary
Concomitant
Neoplasm Malignant Other Serious 5/11/2009 Female 150 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/10/2009 Female 271 lb 5/29/2009 Physician United States
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 11/30/2007 Female 137 lb 6/3/2009 Physician United States
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 4/1/2008 Male 152 lb 6/4/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/15/2009 Physician Malaysia
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 9/9/2008 Female 6/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 4/21/2009 Female 189 lb 6/19/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 6/11/2009 Physician Japan
Primary
Secondary
Concomitant
Localised Infection Hospitalization 6/11/2009 6/22/2009 Physician New Zealand
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 3/12/2009 45 Female 258 lb 6/15/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 111 lb 6/19/2009 Consumer Japan
Primary
Secondary
Concomitant
Lower Limb Fracture Hospitalization 11/30/2007 Female 137 lb 6/25/2009 Physician United States
Primary
Secondary
Concomitant
Arthritis Infective Hospitalization 1/11/2009 Female 6/29/2009 Physician New Zealand
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 9/10/2007 Female 296 lb 7/1/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Arthritis Infective Hospitalization 1/11/2009 Female 7/6/2009 Physician New Zealand
Primary
Secondary
Concomitant
Influenza Hospitalization 6/14/2009 Male 7/6/2009 Physician Canada
Primary
Secondary
Concomitant
Tonsillitis Hospitalization 9/10/2007 Female 296 lb 7/6/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Arthritis Infective Hospitalization 1/11/2009 Female 205 lb 7/8/2009 Physician New Zealand
Primary
Secondary
Concomitant
Nephritis Hospitalization 6/25/2009 Female 114 lb 7/9/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 7/10/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/17/2009 Female 167 lb 7/10/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 111 lb 7/6/2009 Physician Japan
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 7/16/2009 Physician Mexico
Primary
Secondary
Concomitant
Mycobacterium Kansasii Infection 8/1/2008 Male 152 lb 7/20/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/17/2009 Female 167 lb 7/20/2009 Physician United States
Primary
Secondary
Concomitant
Colon Cancer Other Serious 5/11/2009 Female 150 lb 7/20/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 6/23/2009 Female 316 lb 7/21/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2009 Female 151 lb 7/22/2009 Physician Argentina
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 7/1/2009 Female 114 lb 7/24/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/24/2009 Physician United States
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 7/27/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/7/2009 Female 151 lb 7/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 7/31/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 8/5/2009 Physician Argentina
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 8/6/2009 Physician Japan
Primary
Secondary
Concomitant
Ventricular Hypertrophy Life Threatening 2/9/2006 68 Male 8/3/2009 Physician Denmark
Primary
Concomitant
Sepsis Hospitalization 5/6/2009 Female 196 lb 8/7/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 6/9/2009 Female 189 lb 8/10/2009 Physician United States
Primary
Secondary
Concomitant
Electrolyte Imbalance Hospitalization 6/25/2009 Female 114 lb 8/10/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Mycobacterial Infection Hospitalization 8/1/2009 Female 121 lb 8/14/2009 Physician New Zealand
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 8/18/2009 Physician Canada
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 10/13/2008 Female 254 lb 8/18/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 8/11/2009 Physician Germany
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 8/19/2009 Physician Mexico
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 8/29/2008 Female 159 lb 8/21/2009 Physician Argentina
Primary
Secondary
Concomitant
Lymphoma Hospitalization 6/14/2009 Male 254 lb 8/26/2009 Physician Canada
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 8/28/2009 Physician Philippines
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/2/2009 Physician Argentina
Primary
Secondary
Concomitant
Osteonecrosis Disability 10/2/2008 Female 144 lb 9/4/2009 Physician Argentina
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/24/2009 Female 9/4/2009 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Increased Hospitalization 8/24/2009 52 Male 182 lb 9/8/2009 Physician Canada
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/22/2009 Physician Argentina
Primary
Secondary
Concomitant
Lymphoproliferative Disorder Hospitalization 6/14/2009 Male 254 lb 9/24/2009 Physician Canada
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 9/24/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 9/25/2009 Physician United States
Primary
Secondary
Concomitant
Pleural Effusion 8/1/2008 Male 152 lb 9/28/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 9/29/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Intervertebral Disc Disorder Hospitalization 8/1/2009 Female 121 lb 10/2/2009 Physician New Zealand
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 10/6/2009 Physician Argentina
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 10/8/2009 Physician United States
Primary
Secondary
Concomitant
Rheumatoid Nodule Other Serious 11/26/2007 Female 166 lb 10/9/2009 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/17/2009 77 Female 172 lb 10/2/2009 United States
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 10/12/2009 Physician Philippines
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 10/6/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 10/14/2009 Physician Canada
Primary
Secondary
Concomitant
Soft Tissue Infection Hospitalization 8/1/2009 Female 121 lb 10/14/2009 Physician New Zealand
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 10/14/2009 Physician Malaysia
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 11/30/2007 Female 95 lb 10/14/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 10/14/2009 Physician Argentina
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/17/2009 Female 167 lb 10/15/2009 Physician United States
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 10/16/2009 Physician Malaysia
Primary
Secondary
Concomitant
Urine Odour Abnormal Hospitalization 9/17/2009 77 Female 172 lb 10/13/2009 United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/22/2009 Female 131 lb 10/21/2009 Physician Argentina
Primary
Secondary
Concomitant
Swelling Face Hospitalization 6/14/2009 Male 254 lb 10/23/2009 Physician Canada
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 10/23/2009 Physician Argentina
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 10/26/2009 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/28/2009 61 Female 111 lb 10/20/2009 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/27/2009 72 Female 228 lb 10/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 8/7/2009 Female 105 lb 10/30/2009 Physician Philippines
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 10/30/2009 Physician Canada
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 2/8/2009 Female 88 lb 11/2/2009 Physician Malaysia
Primary
Secondary
Concomitant
Vaginal Abscess Hospitalization 10/27/2009 Female 187 lb 11/6/2009 Physician United States
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 11/6/2009 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/6/2009 Female 123 lb 11/6/2009 Physician Malaysia
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 10/28/2009 Male 177 lb 11/11/2009 Physician Canada
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 1/1/2009 Female 198 lb 11/17/2009 Physician Netherlands
Primary
Secondary
Concomitant
Breast Cancer Other Serious 9/10/2009 Female 159 lb 11/17/2009 Physician United States
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 11/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Tachycardia Life Threatening 9/4/2009 Female 157 lb 11/23/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 6/14/2009 Male 254 lb 11/23/2009 Physician Canada
Primary
Secondary
Concomitant
Vaginal Abscess Hospitalization 10/27/2009 Female 187 lb 11/25/2009 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 10/28/2009 Male 177 lb 12/16/2009 Physician Canada
Primary
Secondary
Concomitant
Generalised Oedema Life Threatening 6/23/2009 Female 316 lb 12/23/2009 Physician United States
Primary
Secondary
Concomitant
Breast Mass Hospitalization 12/18/2009 Female 156 lb 12/30/2009 Physician Argentina
Primary
Secondary
Concomitant
Spinal Fracture Life Threatening 12/15/2009 Male 152 lb 12/31/2009 Physician Chile
Primary
Secondary
Concomitant
Breast Mass Hospitalization 12/18/2009 Female 156 lb 1/8/2010 Physician Argentina
Primary
Secondary
Concomitant
Large Intestine Perforation Life Threatening 9/4/2009 Female 157 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 10/28/2009 Male 177 lb 1/11/2010 Physician Canada
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 12/21/2009 Male 119 lb 1/12/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Calculus Urinary Hospitalization 3/1/2007 Female 159 lb 1/21/2010 Physician Argentina
Primary
Secondary
Concomitant

Drug Data