Leflunomide combined with Omeprazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Bronchitis Chronic Hospitalization 8/4/2005 Female 154 lb 2/1/2006 Italy
Primary
Concomitant
Osteitis Hospitalization 8/23/2004 Female 163 lb 2/15/2006 Netherlands
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 12/1/2005 Male 2/22/2006 Pharmacist United States
Primary
Secondary
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
Bronchitis Chronic Hospitalization 8/4/2005 Female 154 lb 3/9/2006 Physician Italy
Primary
Concomitant
Lethargy Hospitalization 5/21/2005 Female 137 lb 3/10/2006 Other Health Professional United Kingdom
Primary
Concomitant
Osteomyelitis Hospitalization 1/1/2006 Female 163 lb 3/16/2006 Netherlands
Primary
Concomitant
Osteomyelitis Hospitalization 1/1/2006 Female 163 lb 3/16/2006 Netherlands
Primary
Concomitant
Tooth Infection Other Serious 2/1/2006 Female 130 lb 3/16/2006 Consumer Canada
Primary
Concomitant
Pulmonary Function Test Decreased Hospitalization 1/1/2004 75 Male 3/11/2006 United Kingdom
Primary
Concomitant
Wheezing Hospitalization 3/6/2006 70 Female 3/15/2006 Colombia
Primary
Concomitant
Vomiting Other Serious 2/15/2006 54 Male 175 lb 3/29/2006 Pharmacist Canada
Primary
Concomitant
Osteitis Hospitalization 8/23/2004 Female 163 lb 4/11/2006 Netherlands
Primary
Concomitant
Toe Amputation Hospitalization 8/23/2004 Female 163 lb 4/11/2006 Netherlands
Primary
Concomitant
Skin Disorder Hospitalization 1/1/2006 Female 163 lb 4/12/2006 Netherlands
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
White Blood Cell Count Decreased Life Threatening 1/11/2006 Male 5/16/2006 Pharmacist United States
Primary
Secondary
Concomitant
Osteomyelitis Hospitalization 1/1/2006 Female 163 lb 5/19/2006 Netherlands
Primary
Concomitant
Pulmonary Embolism Other Serious 11/19/2005 Female 7/11/2006 France
Primary
Concomitant
Arterial Occlusive Disease Other Serious 6/29/2006 Male 209 lb 8/4/2006 Consumer Canada
Primary
Concomitant
Lethargy Other Serious 5/17/2005 Female 137 lb 8/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Subarachnoid Haemorrhage Other Serious Female 8/10/2006 Physician Ireland
Primary
Concomitant
Metastasis Other Serious 6/20/2006 75 Female 8/17/2006 Other Health Professional United Kingdom
Primary
Concomitant
Respiratory Tract Infection Hospitalization 1/1/2005 Female 132 lb 8/17/2006 Physician Germany
Primary
Secondary
Concomitant
Lymphangitis Other Serious 6/1/2006 78 Male 8/18/2006 Physician Belgium
Primary
Concomitant
Diarrhoea Hospitalization 6/2/2006 68 Male 141 lb 9/5/2006 Consumer United States
Primary
Secondary
Concomitant
Wound Other Serious Female 128 lb 9/8/2006 Consumer Canada
Primary
Concomitant
Panic Attack Hospitalization 4/11/2005 Female 128 lb 9/11/2006 Consumer Canada
Primary
Concomitant
Pneumonitis Hospitalization 1/1/2004 75 Male 9/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Panic Attack Hospitalization 4/11/2005 Female 128 lb 9/14/2006 Consumer Canada
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
Ventricular Arrhythmia Life Threatening 2/22/2006 Female 9/21/2006 Physician Germany
Primary
Concomitant
Vomiting Hospitalization 61 Female 9/25/2006
Primary
Secondary
Concomitant
Pleural Effusion Hospitalization 6/24/2005 Female 148 lb 9/27/2006 Consumer United Kingdom
Primary
Concomitant
Skin Disorder Hospitalization 1/1/2006 Female 163 lb 10/18/2006 Netherlands
Primary
Concomitant
Urinary Retention Other Serious 8/15/2006 Male 223 lb 11/2/2006 Other Health Professional United Kingdom
Primary
Concomitant
Oesophageal Ulcer Hospitalization 5/6/2006 Female 134 lb 11/9/2006 Consumer United Kingdom
Primary
Concomitant
Surgery Death Female 207 lb 11/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Pulmonary Embolism Other Serious 11/19/2005 Female 11/16/2006 France
Primary
Concomitant
Osteomyelitis Hospitalization 1/1/2006 Female 163 lb 11/16/2006 Netherlands
Primary
Concomitant
Osteomyelitis Hospitalization 1/1/2006 Female 163 lb 11/20/2006 Netherlands
Primary
Concomitant
Bordetella Infection Hospitalization 50 Male 11/28/2006
Primary
Secondary
Concomitant
Metastases To Bone Other Serious Male 12/8/2006 Physician New Zealand
Primary
Concomitant
Weight Decreased Other Serious 8/1/2003 65 Female 12/18/2006 United States
Primary
Concomitant
Tooth Avulsion Other Serious 4/1/2005 69 Female 12/27/2006 Other Health Professional France
Primary
Concomitant
Cellulitis Hospitalization 11/15/2006 Female 174 lb 1/16/2007 Physician United Kingdom
Primary
Concomitant
Drug Ineffective Hospitalization 7/24/2006 Female 161 lb 1/17/2007 Other Health Professional United Kingdom
Primary
Concomitant
Surgery Death 7/26/2006 Female 207 lb 1/18/2007 Other Health Professional United Kingdom
Primary
Concomitant
Osteonecrosis Hospitalization 2/1/2004 64 Female 110 lb 1/19/2007 Physician Spain
Primary
Concomitant
Mitral Valve Incompetence Hospitalization 12/15/2006 Female 174 lb 1/19/2007 Physician United Kingdom
Primary
Concomitant
Urinary Tract Infection Hospitalization 12/5/2006 37 Female 1/18/2007 Consumer Canada
Primary
Concomitant
Death Death Female 128 lb 1/22/2007 France
Primary
Concomitant
Septic Shock Hospitalization 1/2/2007 Female 1/31/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Septic Shock Hospitalization 1/2/2007 Female 2/8/2007 Other Health Professional United Kingdom
Primary
Concomitant
Prostate Cancer Hospitalization 10/16/2006 Male 183 lb 2/15/2007 Physician Germany
Primary
Secondary
Concomitant
Infarction Death 11/13/2006 Female 128 lb 2/16/2007 France
Primary
Concomitant
Neutropenia Hospitalization 11/13/2006 56 Male 2/16/2007 Pharmacist United States
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 8/28/2006 Female 2/26/2007 Consumer Canada
Primary
Concomitant
Pulmonary Oedema Hospitalization 12/1/2006 Female 185 lb 3/8/2007 Physician United Kingdom
Primary
Concomitant
Mesangioproliferative Glomerulonephritis Hospitalization 2/13/2007 64 Female 3/22/2007 Consumer Spain
Primary
Concomitant
Hepatitis Hospitalization 12/23/2006 Female 150 lb 3/27/2007 Other Health Professional United Kingdom
Primary
Concomitant
Rheumatoid Arthritis Other Serious 6/29/2006 Male 209 lb 3/30/2007 Physician Canada
Primary
Concomitant
Gallbladder Operation Other Serious Male 190 lb 4/4/2007 Consumer Canada
Primary
Concomitant
Rheumatoid Arthritis Other Serious 6/29/2006 Male 209 lb 4/20/2007 Physician Canada
Primary
Concomitant
Urinary Retention Other Serious 8/15/2006 Male 223 lb 4/20/2007 Other Health Professional United Kingdom
Primary
Concomitant
Mesangioproliferative Glomerulonephritis Hospitalization 2/13/2007 64 Female 5/11/2007 Consumer Spain
Primary
Concomitant
Syncope Hospitalization 4/12/2006 Female 143 lb 5/16/2007 Other Health Professional United Kingdom
Primary
Concomitant
Urinary Tract Infection Other Serious 11/16/2006 Female 123 lb 5/24/2007 Other Health Professional United Kingdom
Primary
Concomitant
Urinary Retention Other Serious 8/15/2006 Male 223 lb 5/30/2007 Other Health Professional United Kingdom
Primary
Concomitant
Hypersensitivity Hospitalization 3/13/2007 Male 5/31/2007 Physician Belgium
Primary
Secondary
Concomitant
Syncope Hospitalization 4/12/2006 Female 143 lb 6/1/2007 Physician United Kingdom
Primary
Concomitant
Septic Shock Hospitalization 1/2/2007 Female 6/4/2007 Pharmacist United Kingdom
Primary
Secondary
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
Throat Irritation Hospitalization 12/1/2005 Male 7/11/2007 Belgium
Primary
Secondary
Concomitant
Metastases To Liver Other Serious 5/3/2007 Male 139 lb 7/20/2007 Other Health Professional United Kingdom
Primary
Concomitant
Myocardial Ischaemia Death Male 157 lb 7/20/2007 United Kingdom
Primary
Concomitant
Throat Irritation Hospitalization 12/1/2005 Male 7/24/2007 Belgium
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/18/2007 Female 130 lb 7/31/2007 United Kingdom
Primary
Concomitant
Staphylococcal Infection Life Threatening 3/1/2007 68 Female 146 lb 8/3/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Spinal Decompression Other Serious 1/28/2007 Female 84 lb 8/6/2007 Other Health Professional United Kingdom
Primary
Concomitant
Pulmonary Embolism Life Threatening 3/1/2007 68 Female 146 lb 8/9/2007
Primary
Secondary
Concomitant
Pain Other Serious 56 Female 8/28/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Visual Disturbance Other Serious Female 130 lb 9/28/2007 Canada
Primary
Concomitant
Transaminases Increased Hospitalization 7/1/2007 72 Female 10/9/2007 Spain
Primary
Concomitant
Jaundice Other Serious 9/20/2007 72 Male 10/24/2007
Primary
Concomitant
Respiratory Disorder Female 10/25/2007 Consumer United States
Primary
Concomitant
Medical Device Implantation Other Serious 9/22/2007 Female 141 lb 11/2/2007 Brazil
Primary
Concomitant
Rash Other Serious 8/1/2007 74 Female 11/21/2007
Primary
Concomitant
Liver Function Test Abnormal Other Serious 9/11/2007 72 Male 11/21/2007
Primary
Concomitant
Pseudomembranous Colitis Other Serious 6/18/2007 Female 130 lb 11/30/2007 United Kingdom
Primary
Concomitant
Lower Respiratory Tract Infection Other Serious 5/6/2007 Male 154 lb 12/3/2007 Other Health Professional United Kingdom
Primary
Concomitant
Death Other Serious Male 121 lb 12/3/2007 Other Health Professional United Kingdom
Primary
Concomitant
Visual Disturbance Other Serious 8/10/2007 Female 130 lb 12/3/2007 Canada
Primary
Concomitant
Drug Ineffective 7/24/2007 Female 160 lb 12/14/2007 Consumer United States
Primary
Concomitant
Rash Erythematous 10/11/2007 Female 220 lb 12/14/2007 Consumer United States
Primary
Concomitant
Psoas Abscess Hospitalization 12/23/2006 Female 150 lb 12/21/2007 Other Health Professional United Kingdom
Primary
Concomitant
Toxic Skin Eruption Hospitalization 11/5/2007 Female 1/8/2008 Physician Switzerland
Primary
Concomitant
Joint Dislocation Hospitalization 4/24/2007 Female 154 lb 1/23/2008 United Kingdom
Primary
Concomitant
Death Death 12/18/2007 Female 2/7/2008 Spain
Primary
Concomitant
Infarction Hospitalization 11/13/2006 Female 128 lb 2/7/2008 France
Primary
Concomitant
Prostate Cancer Stage Ii Hospitalization 11/13/2006 Male 183 lb 2/8/2008 Physician Germany
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 9/11/2007 72 Male 2/13/2008
Primary
Concomitant
Cerebrovascular Accident Life Threatening 11/1/2007 Male 251 lb 2/15/2008 Other Health Professional United Kingdom
Primary
Concomitant
Rheumatoid Arthritis Other Serious 4/1/2005 69 Female 2/22/2008 Other Health Professional France
Primary
Concomitant
Hypothermia Other Serious 10/16/2007 Male 121 lb 2/25/2008 Other Health Professional United Kingdom
Primary
Concomitant
Dyspnoea Life Threatening 11/7/2007 Male 251 lb 2/29/2008 United Kingdom
Primary
Concomitant
Diarrhoea Hospitalization 2/15/2006 Female 3/7/2008
Primary
Concomitant
Diarrhoea Hospitalization 2/15/2006 Female 3/7/2008
Primary
Concomitant
Urticaria 10/9/2007 Female 210 lb 3/15/2008 Consumer United States
Primary
Concomitant
Osteoarthritis Other Serious 10/10/2007 Female 3/25/2008 Physician United States
Primary
Concomitant
Cerebral Infarction Life Threatening 12/15/2007 Female 3/28/2008 Spain
Primary
Concomitant
Myositis Hospitalization Female 4/1/2008 Consumer United Kingdom
Primary
Concomitant
Peripheral Embolism Life Threatening 11/7/2007 Male 251 lb 4/4/2008 United Kingdom
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/15/2006 Female 201 lb 4/16/2008 Physician Italy
Primary
Concomitant
Sensory Disturbance Other Serious 2/1/2008 Male 4/24/2008 Physician United Kingdom
Primary
Concomitant
Myocardial Infarction Hospitalization 11/13/2006 Female 128 lb 4/25/2008 France
Primary
Concomitant
Weight Decreased Hospitalization 12/26/2007 Female 5/2/2008 Other Health Professional France
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 8/1/2007 Male 181 lb 5/6/2008 Brazil
Primary
Concomitant
Interacting
Septic Shock Hospitalization Male 5/28/2008 Other Health Professional United Kingdom
Primary
Concomitant
Joint Instability Other Serious 1/19/2008 Female 146 lb 6/2/2008 Germany
Primary
Secondary
Concomitant
Joint Instability Other Serious 1/19/2008 Female 146 lb 6/4/2008 Germany
Primary
Secondary
Concomitant
Osteonecrosis Hospitalization 2/1/2004 64 Female 110 lb 6/6/2008 Physician Spain
Primary
Concomitant
Skin Burning Sensation 1/1/2007 Male 190 lb 6/11/2008 United States
Primary
Concomitant
Joint Instability Other Serious 1/19/2008 Female 146 lb 6/18/2008 Germany
Primary
Secondary
Concomitant
Infarction Hospitalization 2/21/2008 Male 6/26/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Septic Shock Hospitalization 1/2/2007 49 Female 6/30/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Hospitalization 6/10/2008 14 Male 7/7/2008 Other Health Professional France
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 12/15/2007 Female 7/10/2008 Spain
Primary
Concomitant
Cerebrovascular Accident Hospitalization 2/21/2008 Male 7/11/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 12/15/2007 Female 7/11/2008 Spain
Primary
Concomitant
Septic Shock Hospitalization 1/2/2008 49 Female 7/15/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hyperkalaemia Life Threatening 6/10/2008 14 Male 7/28/2008 Other Health Professional France
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 6/16/2008 41 Male 7/29/2008 Physician United Kingdom
Primary
Concomitant
Cerebral Infarction Life Threatening 11/7/2007 Female 7/30/2008 Spain
Primary
Concomitant
Joint Instability Other Serious 1/15/2008 Female 146 lb 8/5/2008 Germany
Primary
Secondary
Concomitant
Type 2 Diabetes Mellitus Death Female 146 lb 8/7/2008 United Kingdom
Primary
Concomitant
Tooth Extraction Other Serious 4/29/2008 8/15/2008 United Kingdom
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 9/21/2007 Female 104 lb 8/25/2008 Physician Brazil
Primary
Concomitant
Weight Decreased Other Serious 7/11/2008 Male 150 lb 8/28/2008 Other Health Professional United Kingdom
Primary
Concomitant
Hyperkalaemia Life Threatening 6/10/2008 14 Male 9/2/2008 Other Health Professional France
Primary
Secondary
Concomitant
Cerebral Infarction Life Threatening 11/7/2007 Female 9/4/2008 Spain
Primary
Concomitant
Pneumonia Other Serious 1/24/2007 60 Female 190 lb 9/10/2008 Physician Finland
Primary
Secondary
Concomitant
Skin Burning Sensation 1/1/2007 Male 190 lb 9/12/2008 United States
Primary
Concomitant

Drug Data