Leflunomide combined with Sulfasalazine

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Cerebrovascular Accident Death 9/1/2005 Female 176 lb 1/13/2006 Physician United Kingdom
Primary
Concomitant
Hepatotoxicity Hospitalization 3/20/2005 Male 209 lb 1/16/2006 United Kingdom
Primary
Concomitant
Hepatotoxicity Hospitalization 3/20/2005 Male 209 lb 1/24/2006 United Kingdom
Primary
Concomitant
Respiratory Failure Life Threatening 5/30/2005 Male 168 lb 1/27/2006 Physician United Kingdom
Primary
Concomitant
Diverticulitis Hospitalization 1/1/2006 Female 155 lb 2/1/2006 Canada
Primary
Concomitant
Sepsis Hospitalization 12/12/2005 Male 220 lb 2/9/2006 Canada
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
Streptococcal Sepsis Hospitalization 12/12/2005 Male 220 lb 4/6/2006 Physician Canada
Primary
Concomitant
Knee Arthroplasty Other Serious Male 138 lb 5/2/2006 Consumer Canada
Primary
Concomitant
Infusion Related Reaction Hospitalization 1/3/2006 Female 222 lb 5/3/2006 Physician United States
Primary
Concomitant
Rheumatoid Arthritis Hospitalization 11/7/2005 Female 126 lb 5/3/2006 Other Health Professional United Kingdom
Primary
Concomitant
Uveitis Other Serious Female 5/4/2006 Other Health Professional Australia
Primary
Concomitant
Staphylococcal Infection Other Serious 12/1/2004 Female 176 lb 5/8/2006 Other Health Professional United Kingdom
Primary
Concomitant
Weight Decreased Hospitalization 12/12/2005 Male 225 lb 5/19/2006 Physician Canada
Primary
Concomitant
Infusion Related Reaction Hospitalization 1/3/2006 Female 338 lb 6/2/2006 Physician United States
Primary
Concomitant
Nausea Other Serious 4/20/2006 Male 247 lb 6/20/2006 Other Health Professional United Kingdom
Primary
Concomitant
Malabsorption Hospitalization 4/7/2006 Female 128 lb 6/26/2006 Other Health Professional United Kingdom
Primary
Concomitant
Tooth Infection Other Serious 5/14/2004 54 Male 229 lb 6/28/2006 Physician United States
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
Skin Lesion 8/15/2005 Male 148 lb 8/3/2006 Other Health Professional United Kingdom
Primary
Concomitant
Hepatotoxicity Other Serious 3/20/2005 Male 209 lb 8/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Upper Respiratory Tract Infection Other Serious 5/14/2004 54 Male 229 lb 8/11/2006 Physician United States
Primary
Concomitant
Proctitis Ulcerative Other Serious 8/15/2005 56 Female 8/14/2006 Physician Germany
Primary
Secondary
Concomitant
Influenza Like Illness Hospitalization Female 8/17/2006 Physician Germany
Primary
Secondary
Concomitant
Rheumatoid Arthritis Hospitalization 11/7/2005 Female 126 lb 8/18/2006 Other Health Professional United Kingdom
Primary
Concomitant
Atelectasis Hospitalization 6/9/2006 59 Female 185 lb 8/30/2006 Other Health Professional Canada
Primary
Secondary
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 Life Threatening 10/1/2005 Male 172 lb 9/26/2006 Physician Germany
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
Infection Other Serious 12/7/2004 Female 140 lb 11/3/2006 Physician United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 54 Female 11/13/2006 Other Health Professional United Kingdom
Primary
Concomitant
Lymphoma Other Serious 7/12/2006 Female 11/21/2006 Other Health Professional United Kingdom
Primary
Concomitant
Bordetella Infection Hospitalization 50 Male 11/28/2006
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 8/29/2006 Female 121 lb 12/13/2006 Other Health Professional United Kingdom
Primary
Concomitant
Urine Analysis Abnormal Hospitalization 11/5/2006 66 Male 12/28/2006
Primary
Secondary
Concomitant
Renal Cell Carcinoma Stage Unspecified Life Threatening 9/15/2006 Female 1/8/2007 Other Health Professional Australia
Primary
Concomitant
Epstein-barr Virus Infection Other Serious 11/1/2004 Female 2/5/2007 Netherlands
Primary
Concomitant
Sepsis Life Threatening 10/15/2005 Male 172 lb 2/5/2007 Physician Germany
Primary
Concomitant
Infection Hospitalization 9/6/2006 Female 2/8/2007 Consumer United Kingdom
Primary
Concomitant
Breast Mass Other Serious Female 148 lb 2/9/2007 Consumer Canada
Primary
Concomitant
Foot Operation Hospitalization 4/8/2006 75 Female 2/9/2007 Physician Germany
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
Epstein-barr Virus Infection 11/1/2004 Female 4/5/2007 Netherlands
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 54 Female 5/30/2007 Other Health Professional United Kingdom
Primary
Concomitant
Pustular Psoriasis Hospitalization 12/25/2006 Female 6/7/2007 Other Health Professional Australia
Primary
Concomitant
Oedema Peripheral Hospitalization 10/15/2006 Female 201 lb 6/8/2007 Physician Italy
Primary
Concomitant
Oedema Peripheral Hospitalization 10/15/2006 Female 201 lb 7/5/2007 Physician Italy
Primary
Concomitant
Pustular Psoriasis Hospitalization 12/25/2006 Female 7/16/2007 Consumer Australia
Primary
Concomitant
Myocardial Ischaemia Death Male 157 lb 7/20/2007 United Kingdom
Primary
Concomitant
Rheumatoid Nodule Hospitalization 10/28/2004 Male 168 lb 7/25/2007 Other Health Professional United Kingdom
Primary
Concomitant
Enteritis Hospitalization 1/26/2006 69 Female 7/27/2007 Germany
Primary
Secondary
Nasal Operation Hospitalization 11/2/2006 36 Male 8/8/2007 Germany
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/9/2007 70 Male 8/15/2007 Germany
Primary
Concomitant
Weight Decreased Hospitalization 3/1/2006 Male 142 lb 8/17/2007 Germany
Primary
Concomitant
Neoplasm Skin Other Serious 9/15/2007 Male 9/26/2007 Consumer United States
Primary
Concomitant
Thymus Abscess Hospitalization 53 Female 11/1/2007
Primary
Secondary
Concomitant
Psoriasis Hospitalization 2/20/2007 Male 148 lb 11/13/2007 United Kingdom
Primary
Concomitant
Respiratory Failure Hospitalization 3/9/2007 70 Male 11/21/2007 Germany
Primary
Concomitant
Multiple Fractures Hospitalization 3/5/2004 Female 146 lb 12/7/2007 United Kingdom
Primary
Concomitant
Neoplasm Skin Other Serious 8/30/2007 Male 12/11/2007 Physician United States
Primary
Concomitant
Injection Site Warmth 5/8/2007 Female 12/12/2007 Consumer United States
Primary
Concomitant
Blood Glucose Abnormal 6/17/2007 Female 12/12/2007 Consumer United States
Primary
Concomitant
Lower Limb Fracture Life Threatening 8/29/2007 Female 12/20/2007 Consumer United States
Primary
Concomitant
Rectosigmoid Cancer Other Serious 4/1/2007 Female 1/18/2008 Other Health Professional France
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/9/2007 70 Male 2/8/2008 Germany
Primary
Secondary
Concomitant
Ankle Arthroplasty Hospitalization 7/6/2007 64 Male 2/8/2008 Germany
Primary
Concomitant
Weight Decreased Hospitalization 3/1/2006 Male 142 lb 2/8/2008 Germany
Primary
Concomitant
Prostate Cancer Stage Ii Hospitalization 11/13/2006 Male 183 lb 2/8/2008 Physician Germany
Primary
Secondary
Concomitant
Loss Of Consciousness Hospitalization 6/1/2007 Male 2/25/2008 Physician Turkey
Primary
Concomitant
Hypoglycaemia Other Serious 64 Male 3/10/2008 Other Health Professional Turkey
Primary
Concomitant
Pregnancy Other Serious 11/1/2007 23 Female 3/12/2008 Physician Brazil
Primary
Concomitant
Nasopharyngitis Hospitalization 1/1/2007 Male 137 lb 3/14/2008 Germany
Primary
Concomitant
Drug Ineffective 11/1/2007 Female 180 lb 3/14/2008 Consumer United States
Primary
Concomitant
Sinusitis 2/5/2008 Female 150 lb 3/15/2008 United States
Primary
Concomitant
Accidental Exposure 2/15/2008 Female 190 lb 3/15/2008 Consumer United States
Primary
Concomitant
Pulmonary Tuberculosis Life Threatening 2/29/2008 Female 209 lb 3/27/2008 Physician Brazil
Primary
Concomitant
Tuberculosis Other Serious 73 Female 3/25/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypoglycaemic Unconsciousness Hospitalization 6/1/2007 62 Male 3/31/2008 Other Health Professional Turkey
Primary
Concomitant
Oedema Peripheral Hospitalization 10/15/2006 Female 201 lb 4/16/2008 Physician Italy
Primary
Concomitant
Nasopharyngitis Hospitalization 1/1/2007 Male 137 lb 4/17/2008 Germany
Primary
Concomitant
Sensory Disturbance Other Serious 2/1/2008 Male 4/24/2008 Physician United Kingdom
Primary
Concomitant
Hypoglycaemia Hospitalization 6/1/2007 64 Male 4/24/2008 Other Health Professional Turkey
Primary
Concomitant
Eosinophilic Pneumonia Hospitalization 10/1/2007 Female 5/2/2008 Physician Australia
Primary
Secondary
Concomitant
Hepatitis C Other Serious 62 Female 5/9/2008 Turkey
Primary
Secondary
Concomitant
Rectosigmoid Cancer Other Serious 4/1/2007 Female 5/28/2008 Other Health Professional France
Primary
Secondary
Concomitant
Hepatitis C Other Serious 62 Female 6/2/2008 Turkey
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 6/1/2007 62 Male 5/19/2008 United States
Primary
Concomitant
Injection Site Nodule 9/1/2007 Female 6/12/2008 United States
Primary
Concomitant
Scratch Male 234 lb 6/13/2008 Physician United States
Primary
Concomitant
Tuberculous Tenosynovitis Hospitalization 48 Female 6/17/2008 Germany
Primary
Secondary
Laboratory Test Abnormal Other Serious 62 Female 6/25/2008
Primary
Secondary
Breast Cancer Other Serious 8/12/2007 Female 187 lb 7/11/2008 Other Health Professional United Kingdom
Primary
Concomitant
Skin Cancer Other Serious 6/19/2006 Male 161 lb 7/21/2008 United Kingdom
Primary
Concomitant
Red Blood Cell Count Decreased Hospitalization Female 8/1/2008 Brazil
Primary
Concomitant
Interacting
Vomiting Hospitalization 2/11/2004 47 Female 8/8/2008 Germany
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 8/7/2007 Male 8/13/2008 Germany
Primary
Concomitant
Progesterone Receptor Assay Positive Other Serious 5/1/2008 Female 9/3/2008 Other Health Professional France
Primary
Secondary
Pneumonia Other Serious 1/24/2007 60 Female 190 lb 9/10/2008 Physician Finland
Primary
Secondary
Concomitant
Breast Cancer Other Serious 8/12/2007 Female 187 lb 9/11/2008 Other Health Professional United Kingdom
Primary
Concomitant
Breast Cancer Hospitalization Female 9/11/2008 Other Health Professional France
Primary
Secondary
Red Blood Cell Count Decreased Hospitalization Female 9/12/2008 Brazil
Primary
Concomitant
Interacting
Treatment Noncompliance 1/1/2006 Female 160 lb 9/12/2008
Primary
Secondary
Concomitant
Weight Decreased 6/1/2008 Male 169 lb 9/12/2008 Physician United States
Primary
Concomitant
Stress Fracture Other Serious 9/23/2008 Belgium
Primary
Concomitant
Sensory Disturbance Disability 1/1/2008 Female 9/24/2008 Physician Finland
Primary
Concomitant
Interacting
Mouth Ulceration Hospitalization 49 Female 9/25/2008 United Kingdom
Primary
Secondary
Concomitant
Mouth Ulceration Hospitalization 49 Female 10/9/2008 United Kingdom
Primary
Secondary
Concomitant
Herpes Simplex Hospitalization 49 Female 10/14/2008 United Kingdom
Primary
Secondary
Concomitant
Surgery Hospitalization 2/22/2008 Female 163 lb 10/29/2008 United Kingdom
Primary
Concomitant
Vascular Operation Hospitalization 2/22/2008 Female 163 lb 10/31/2008 United Kingdom
Primary
Concomitant
Respiratory Tract Congestion 3/15/2008 Female 12/8/2008 Consumer United States
Primary
Concomitant
Injection Site Warmth 4/28/2008 Female 12/11/2008 Consumer United States
Primary
Concomitant
Pregnancy Other Serious 11/1/2007 23 Female 159 lb 12/12/2008 Physician Brazil
Primary
Concomitant
Pruritus 7/9/2008 Female 12/13/2008 Consumer United States
Primary
Concomitant
Injection Site Erythema 7/31/2008 Female 12/17/2008 Consumer United States
Primary
Concomitant
Atrial Flutter Other Serious 8/13/2008 59 Male 220 lb 12/31/2008 Other Health Professional Canada
Primary
Concomitant
Respiratory Failure Other Serious 3/12/2008 Female 174 lb 1/20/2009 United Kingdom
Primary
Concomitant
Arthrodesis Other Serious 8/7/2008 50 Female 2/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Death 9/2/2008 Male 132 lb 2/12/2009 United Kingdom
Primary
Concomitant
Benign Soft Tissue Neoplasm Other Serious 5/3/2007 Male 2/12/2009 Other Health Professional Spain
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 8/25/2008 2/11/2009 Physician Colombia
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Other Serious 8/25/2008 2/18/2009 Physician Colombia
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 12/11/2008 Female 3/2/2009 Consumer United Kingdom
Primary
Concomitant
Pneumonia Other Serious 1/1/2008 Female 135 lb 3/6/2009 Physician United States
Primary
Secondary
Concomitant
Pseudomonas Infection Other Serious 1/27/2008 Female 139 lb 3/6/2009 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 12/11/2008 57 Female 3/25/2009 Other Health Professional United Kingdom
Primary
Concomitant
Acute Myocardial Infarction Hospitalization 12/12/2008 Female 4/10/2009 Consumer United Kingdom
Primary
Concomitant
Respiratory Tract Infection Viral Hospitalization 4/3/2009 Female 5/12/2009 Physician United Kingdom
Primary
Concomitant
Rheumatoid Arthritis Other Serious 71 Female 5/15/2009
Primary
Secondary
Concomitant
Respiratory Tract Infection Viral Hospitalization 4/3/2009 Female 5/20/2009 Physician United Kingdom
Primary
Concomitant
Neuropathy Peripheral Disability 2/1/2006 80 Female 7/2/2009
Primary
Concomitant
Thrombosis Mesenteric Vessel Hospitalization 5/24/2002 41 Female 7/10/2009
Primary
Secondary
Concomitant
Hip Arthroplasty Hospitalization 1/27/2008 52 Male 8/6/2009 Germany
Primary
Concomitant
Respiratory Tract Infection Viral Hospitalization 4/3/2009 Female 8/18/2009 Physician United Kingdom
Primary
Concomitant
Exostosis Hospitalization 1/1/2009 46 Female 8/21/2009 Consumer Germany
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Other Serious 6/16/2009 Female 8/26/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Urticaria Other Serious 1/1/2008 Female 135 lb 8/28/2009 Consumer United States
Primary
Concomitant
Incorrect Dose Administered 10/25/2006 Male 170 lb 9/11/2009 Consumer United States
Primary
Concomitant
Incorrect Dose Administered 8/1/2007 Female 180 lb 9/12/2009 Consumer United States
Primary
Concomitant
Incorrect Dose Administered 2/15/2008 Female 190 lb 9/12/2009 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 7/13/2008 Male 10/13/2009 United Kingdom
Primary
Secondary
Concomitant
Skin Infection Other Serious 8/7/2008 50 Female 10/29/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Pain Other Serious 9/11/2006 Male 183 lb 11/4/2009 Brazil
Primary
Concomitant
Toothache Other Serious 9/29/2009 Female 204 lb 11/4/2009 Canada
Primary
Concomitant

Drug Data