Leflunomide combined with Methotrexate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Renal Disorder Hospitalization 11/16/2005 Female 162 lb 1/3/2006 Consumer United States
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 11/16/2005 Female 162 lb 1/24/2006 Consumer United States
Primary
Concomitant
Pharyngeal Oedema Other Serious 1/10/2006 Female 280 lb 1/26/2006 Canada
Primary
Concomitant
Polyarthritis Hospitalization 4/19/2005 41 Female 1/27/2006 France
Primary
Secondary
Concomitant
Vertigo Hospitalization 8/11/2005 Female 1/27/2006 Italy
Primary
Concomitant
Pancreatitis Hospitalization 1/4/2006 31 Female 128 lb 1/25/2006 Physician Mexico
Primary
Concomitant
Diverticulitis Hospitalization 1/1/2006 Female 155 lb 2/1/2006 Canada
Primary
Concomitant
Disseminated Tuberculosis Life Threatening 11/1/2005 Male 159 lb 2/2/2006 Physician Romania
Primary
Secondary
Throat Tightness Other Serious 1/10/2006 Female 280 lb 2/3/2006 Canada
Primary
Concomitant
Psoriasis Other Serious 8/4/2005 Female 120 lb 2/6/2006 Canada
Primary
Concomitant
Polyarthritis Hospitalization 4/19/2005 41 Female 2/7/2006 France
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 6/7/2005 53 Female 2/10/2006 Germany
Primary
Secondary
Concomitant
Cerebrovascular Accident Death 11/1/2005 Female 2/10/2006 United States
Primary
Concomitant
Blood Pressure Increased Hospitalization 1/3/2006 Female 222 lb 2/14/2006 Consumer United States
Primary
Concomitant
Peridiverticular Abscess Hospitalization 1/1/2006 Female 155 lb 2/17/2006 Physician Canada
Primary
Concomitant
Impaired Healing Hospitalization 5/4/2005 65 Male 2/21/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Chronic Tonsillitis Other Serious 1/25/2006 Female 2/24/2006 Other Health Professional Czech Republic
Primary
Concomitant
T-cell Lymphoma Stage Iv Hospitalization 4/1/2004 65 Male 2/28/2006 Other Health Professional France
Primary
Secondary
Concomitant
T-cell Lymphoma Stage Iv Hospitalization 4/1/2004 65 Male 2/28/2006 Consumer United States
Primary
Secondary
Concomitant
T-cell Lymphoma Stage Iv Hospitalization 4/1/2004 65 Male 2/24/2006 France
Primary
Secondary
T-cell Lymphoma Stage Iv Hospitalization 4/1/2004 65 Male 3/1/2006 Physician United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Hospitalization 5/9/2005 58 Female 150 lb 12/27/2005 Other Health Professional United States
Primary
Concomitant
Pulmonary Function Test Decreased Hospitalization 1/1/2004 75 Male 3/11/2006 United Kingdom
Primary
Concomitant
Liver Function Test Abnormal Life Threatening 1/9/2002 Female 3/21/2006 Physician United States
Primary
Concomitant
Urticaria Pigmentosa Hospitalization 1/1/2005 Male 3/21/2006 Physician Australia
Primary
Secondary
Concomitant
Visual Disturbance Disability 7/1/2005 39 Female 3/22/2006 Consumer United States
Primary
Concomitant
Eosinophilia Other Serious 7/1/2001 55 Female 3/23/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Hip Surgery Hospitalization 12/7/2005 51 Female 3/13/2006 Consumer Canada
Primary
Concomitant
Tuberculosis Other Serious 1/1/2004 Female 3/30/2006 Other Health Professional Finland
Primary
Concomitant
Urticaria Hospitalization 1/1/2005 Female 123 lb 4/13/2006 Other Health Professional France
Primary
Concomitant
T-cell Lymphoma Stage Iv Hospitalization 4/1/2004 65 Male 4/25/2006 Consumer United States
Primary
Secondary
Concomitant
Infusion Related Reaction Hospitalization 1/3/2006 Female 222 lb 5/3/2006 Physician United States
Primary
Concomitant
Eosinophilia Other Serious 7/1/2001 55 Female 5/8/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Psoriasis Other Serious 12/1/2005 Female 120 lb 5/8/2006 Consumer Canada
Primary
Concomitant
Yellow Skin Other Serious 4/1/1997 Female 5/10/2006 Consumer United States
Primary
Secondary
Concomitant
Hospitalisation Hospitalization Female 170 lb 5/12/2006 Consumer Canada
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 1/11/2006 Male 5/16/2006 Pharmacist United States
Primary
Secondary
Concomitant
Yellow Skin Other Serious 4/1/1997 Female 5/31/2006 Physician United States
Primary
Secondary
Concomitant
Infusion Related Reaction Hospitalization 1/3/2006 Female 338 lb 6/2/2006 Physician United States
Primary
Concomitant
Renal Colic Hospitalization 10/28/2005 Male 209 lb 6/2/2006 Italy
Primary
Concomitant
Liver Function Test Abnormal Life Threatening 1/9/2002 Female 6/5/2006 Physician United States
Primary
Concomitant
Staphylococcal Infection Hospitalization 4/21/2006 Female 170 lb 6/21/2006 Consumer Canada
Primary
Concomitant
Lymph Node Tuberculosis Other Serious 67 Female 6/22/2006 Other Health Professional Greece
Primary
Concomitant
Malabsorption Hospitalization 4/7/2006 Female 128 lb 6/26/2006 Other Health Professional United Kingdom
Primary
Concomitant
Vasculitic Rash Other Serious 12/18/2001 Female 118 lb 6/28/2006 Physician United States
Primary
Concomitant
Diffuse Large B-cell Lymphoma Stage Iii Other Serious 6/27/2005 Female 161 lb 7/11/2006 Other Health Professional United States
Primary
Concomitant
Thrombosis Hospitalization 1/1/2003 62 Female 7/13/2006 Consumer Australia
Primary
Concomitant
Pruritus Other Serious 50 Female 7/19/2006 Physician Brazil
Primary
Concomitant
Rectal Haemorrhage Hospitalization 5/26/2006 56 Male 7/14/2006 United Kingdom
Primary
Concomitant
Weight Increased Other Serious 1/1/2006 66 Female 6/5/2006 United States
Primary
Secondary
Concomitant
Tuberculosis Skin Test Positive Hospitalization 7/19/2006 50 Female 187 lb 7/28/2006 Physician Greece
Primary
Concomitant
Staphylococcal Infection Hospitalization 10/4/2005 Female 7/28/2006 Physician Belgium
Primary
Concomitant
B-cell Lymphoma Stage Ii Other Serious 4/13/2006 68 Male 132 lb 7/31/2006 Other Health Professional Germany
Primary
Concomitant
Synovitis Other Serious 10/1/1999 77 Female 7/13/2006
Primary
Secondary
Pulmonary Tuberculosis Death 7/6/2004 Male 126 lb 8/2/2006 Other Health Professional United Kingdom
Primary
Concomitant
Thyroid Neoplasm Life Threatening 4/21/2006 Female 167 lb 8/4/2006 Other Health Professional Canada
Primary
Concomitant
B-cell Small Lymphocytic Lymphoma Stage Iv Other Serious 12/10/2003 Female 142 lb 8/8/2006 Physician United States
Primary
Concomitant
Diffuse Large B-cell Lymphoma Stage Iii Other Serious 6/27/2005 Female 161 lb 8/8/2006 Other Health Professional United States
Primary
Concomitant
Shunt Occlusion Hospitalization 7/18/2006 Female 8/10/2006 Consumer Canada
Primary
Concomitant
Proctitis Ulcerative Other Serious 8/15/2005 56 Female 8/14/2006 Physician Germany
Primary
Secondary
Concomitant
Wound Dehiscence Life Threatening 10/17/2005 67 Male 8/14/2006 Other Health Professional Germany
Primary
Concomitant
Respiratory Tract Infection Hospitalization 1/1/2005 Female 132 lb 8/17/2006 Physician Germany
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 12/15/2005 Female 134 lb 8/17/2006 Other Health Professional United Kingdom
Primary
Concomitant
Lymphangitis Other Serious 6/1/2006 78 Male 8/18/2006 Physician Belgium
Primary
Concomitant
Neuropathy Peripheral Other Serious 76 Female 8/14/2006 United States
Primary
Secondary
Concomitant
Bronchospasm Hospitalization 12/12/2005 36 Male 8/30/2006 Other Health Professional Germany
Primary
Secondary
Concomitant
Depression Hospitalization 7/4/2006 22 Female 8/30/2006 Other Health Professional United Kingdom
Primary
Concomitant
Pruritus Other Serious 50 Female 9/1/2006 Physician Brazil
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/2/2006 68 Male 141 lb 9/5/2006 Consumer United States
Primary
Secondary
Concomitant
Bronchospasm Hospitalization 12/12/2005 36 Male 9/6/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Shunt Occlusion Hospitalization 7/18/2006 Female 9/8/2006 Consumer Canada
Primary
Concomitant
Pneumonitis Hospitalization 1/1/2004 75 Male 9/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Pulmonary Fibrosis Death 5/31/2006 66 Female 8/29/2006 United Kingdom
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 1/1/2004 75 Male 9/12/2006 United Kingdom
Primary
Concomitant
Lymphangitis Other Serious 6/1/2006 78 Male 9/21/2006 Physician Belgium
Primary
Concomitant
Tachycardia Other Serious 7/24/2006 Female 106 lb 9/22/2006 Other Health Professional United Kingdom
Primary
Concomitant
Staphylococcal Infection Hospitalization 10/4/2005 Female 9/21/2006 Physician Belgium
Primary
Concomitant
Sepsis Hospitalization 1/1/2006 59 Female 192 lb 9/29/2006 Physician United States
Primary
Secondary
Concomitant
Malignant Melanoma Other Serious 59 Female 10/2/2006 Consumer United States
Primary
Concomitant
Staphylococcal Infection Hospitalization 10/4/2005 Female 10/4/2006 Physician Belgium
Primary
Concomitant
Infection Hospitalization 9/6/2006 Female 10/13/2006 Consumer United Kingdom
Primary
Concomitant
Dyspnoea Hospitalization Female 10/13/2006 Physician Australia
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 6/27/2006 Female 130 lb 10/17/2006 Other Health Professional United Kingdom
Primary
Concomitant
Hepatitis A Hospitalization 6/1/2006 Female 10/18/2006 Physician Brazil
Primary
Concomitant
Vomiting Other Serious 8/1/2006 Female 10/18/2006 Physician Australia
Primary
Concomitant
Systemic Lupus Erythematosus Death 12/1/2003 Female 10/31/2006 Physician United States
Primary
Concomitant
Sepsis Hospitalization 1/1/2006 59 Female 192 lb 11/1/2006 Physician United States
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 6/27/2006 Female 130 lb 11/3/2006 Other Health Professional United Kingdom
Primary
Concomitant
Shunt Occlusion Hospitalization 7/18/2006 Female 11/7/2006 Consumer Canada
Primary
Concomitant
Dyspnoea Hospitalization Female 11/10/2006 Physician Australia
Primary
Concomitant
Pulmonary Tuberculosis Hospitalization 7/1/2005 Male 11/16/2006 Other Health Professional Finland
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 11/6/2006 Female 11/20/2006 Other Health Professional United Kingdom
Primary
Concomitant
Lymphoma Other Serious 7/12/2006 Female 11/21/2006 Other Health Professional United Kingdom
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious 6/27/2006 Female 130 lb 11/21/2006 Other Health Professional United Kingdom
Primary
Concomitant
Sepsis Other Serious 9/24/2004 45 Female 168 lb 11/21/2006 France
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/17/2006 Female 143 lb 11/22/2006 Consumer Brazil
Primary
Concomitant
Rheumatoid Arthritis Other Serious 10/10/2006 Male 11/30/2006 Other Health Professional France
Primary
Secondary
Concomitant
Pyothorax Hospitalization 12/15/2004 Male 141 lb 11/30/2006 Germany
Primary
Concomitant
Unevaluable Event Hospitalization 11/14/2006 75 Female 154 lb 12/1/2006 Physician Greece
Primary
Secondary
Concomitant
Thrombosis Other Serious Female 12/1/2006 Consumer Brazil
Primary
Concomitant
Rheumatoid Factor Increased Other Serious 11/1/2005 Female 104 lb 12/4/2006 Consumer Brazil
Primary
Concomitant
Prostate Cancer Other Serious 11/1/2006 Male 12/6/2006 Physician United States
Primary
Concomitant
Vulval Cancer Other Serious 1/1/2006 Female 182 lb 12/13/2006 Physician United States
Primary
Concomitant
Skin Exfoliation Other Serious 7/1/2006 Female 12/13/2006 Physician Belgium
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 54 Female 12/13/2006 Other Health Professional Italy
Primary
Concomitant
Interacting
Death Death 12/7/2006 70 Female 12/15/2006 Consumer Canada
Primary
Concomitant
Rheumatoid Nodule Other Serious 11/1/2005 Female 104 lb 12/15/2006 Consumer Brazil
Primary
Concomitant
Death Death 12/6/2006 70 Female 12/19/2006 Physician Canada
Primary
Concomitant
Mycosis Fungoides Other Serious 4/19/2006 Male 203 lb 12/22/2006 Physician United States
Primary
Concomitant
Renal Cell Carcinoma Stage Unspecified Life Threatening 9/15/2006 Female 1/8/2007 Other Health Professional Australia
Primary
Concomitant
Convulsion Hospitalization 10/15/2006 Male 141 lb 1/9/2007 Other Health Professional United Kingdom
Primary
Concomitant
Cutaneous Lupus Erythematosus Hospitalization Female 1/19/2007 Other Health Professional France
Primary
Concomitant
Scab Other Serious 7/14/2006 39 Male 1/22/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Death Death Female 128 lb 1/22/2007 France
Primary
Concomitant
Vasculitis Other Serious 1/1/2006 Male 163 lb 1/24/2007 Other Health Professional United Kingdom
Primary
Concomitant
Bunion Other Serious 11/1/2004 Female 134 lb 1/26/2007 Consumer United Kingdom
Primary
Concomitant
Pain In Extremity Other Serious Female 1/27/2007 Consumer Brazil
Primary
Concomitant
Osteoarthritis Hospitalization 10/17/2006 Female 152 lb 1/27/2007 Physician Germany
Primary
Concomitant
Vitamin B12 Deficiency Hospitalization 12/4/2006 76 Male 162 lb 1/24/2007 Pharmacist United States
Primary
Secondary
Colitis Ulcerative Other Serious 12/19/2006 Male 2/1/2007 Physician Czech Republic
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 11/1/2004 Female 2/5/2007 Netherlands
Primary
Concomitant
Infection Hospitalization 9/6/2006 Female 2/8/2007 Consumer United Kingdom
Primary
Concomitant
Spinal Fracture Other Serious 6/15/2006 59 Female 2/9/2007 Physician Germany
Primary
Secondary
Concomitant
Prosthesis Implantation Hospitalization 9/13/2005 62 Female 2/14/2007 Other Health Professional Germany
Primary
Concomitant
Infarction Death 11/13/2006 Female 128 lb 2/16/2007 France
Primary
Concomitant
Drug Exposure During Pregnancy 29 Female 2/26/2007
Primary
Secondary
Rheumatoid Arthritis Other Serious 8/28/2006 Female 2/26/2007 Consumer Canada
Primary
Concomitant
Hemiplegia Hospitalization 10/1/2005 Female 3/20/2007 Physician Costa Rica
Primary
Concomitant
Erythema Multiforme Other Serious 11/5/2000 70 Female 3/30/2007 Physician Spain
Primary
Concomitant
Oedema Peripheral Hospitalization 6/17/2006 Female 161 lb 4/3/2007 Other Health Professional United Kingdom
Primary
Concomitant
Epstein-barr Virus Infection 11/1/2004 Female 4/5/2007 Netherlands
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 3/12/2007 Female 117 lb 4/11/2007 Physician France
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 3/12/2007 Female 117 lb 4/20/2007 Physician France
Primary
Concomitant
Hypergammaglobulinaemia Benign Monoclonal Other Serious 4/10/2007 Female 110 lb 4/24/2007 Other Health Professional United Kingdom
Primary
Concomitant
Mass Other Serious 1/1/2006 Male 4/24/2007 Physician United States
Primary
Concomitant
Cerebrovascular Accident Other Serious 1/5/2007 Female 99 lb 4/25/2007 Other Health Professional United Kingdom
Primary
Concomitant
Drug Ineffective Hospitalization Female 140 lb 4/25/2007 Consumer Canada
Primary
Concomitant
Pancreatitis Acute Hospitalization 12/17/2006 42 Female 128 lb 4/25/2007 Physician Spain
Primary
Secondary
Squamous Cell Carcinoma Other Serious 4/12/2006 Male 161 lb 4/26/2007 Other Health Professional United Kingdom
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 3/12/2007 Female 117 lb 4/27/2007 Physician France
Primary
Secondary
Concomitant
Tumour Invasion Life Threatening 3/12/2007 58 Female 4/23/2007 France
Primary
Secondary
Syncope Hospitalization 4/12/2006 Female 143 lb 5/16/2007 Other Health Professional United Kingdom
Primary
Concomitant
Neoplasm Skin Hospitalization 2/28/2006 Female 5/18/2007 Other Health Professional France
Primary
Secondary
Concomitant
Benign Neoplasm Other Serious 1/1/2006 Male 208 lb 5/24/2007 Physician United States
Primary
Concomitant
Urinary Tract Infection Other Serious 11/16/2006 Female 123 lb 5/24/2007 Other Health Professional United Kingdom
Primary
Concomitant
Pleural Effusion Other Serious 12/1/2003 Female 121 lb 5/29/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/15/2006 Female 201 lb 6/8/2007 Physician Italy
Primary
Concomitant
Hypergammaglobulinaemia Benign Monoclonal Other Serious 4/10/2007 Female 110 lb 6/11/2007 Other Health Professional United Kingdom
Primary
Concomitant
Staphylococcal Sepsis Hospitalization 2/21/2007 56 Female 6/12/2007 Physician Germany
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 3/12/2007 Male 225 lb 6/12/2007 Other Health Professional United Kingdom
Primary
Concomitant

Drug Data