Arava combined with Omeprazole

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Renal Impairment Hospitalization 3/7/2005 Female 146 lb 1/27/2006 Physician United Kingdom
Primary
Concomitant
Hepatic Enzyme Increased Other Serious 12/1/2005 63 Female 194 lb 2/15/2006
Primary
Secondary
Concomitant
Hepatocellular Damage Hospitalization 6/15/2004 46 Female 163 lb 2/17/2006
Primary
Concomitant
Neutropenia Hospitalization 12/24/2005 46 Female 2/22/2006
Primary
Secondary
Concomitant
Serum Ferritin Increased Hospitalization 12/24/2005 46 Female 2/22/2006 Physician France
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 1/6/2006 58 Male 3/10/2006
Primary
Concomitant
Twin Pregnancy Other Serious 1/5/2006 22 Female 3/21/2006 Physician United Kingdom
Primary
Concomitant
Unintended Pregnancy Congenital Anomaly Male 5 lb 3/21/2006 Physician United Kingdom
Primary
Concomitant
Rash Other Serious 72 Female 3/22/2006 Consumer United Kingdom
Primary
Concomitant
Ventricular Hypoplasia Other Serious 10/1/2005 33 Female 106 lb 3/22/2006 Physician France
Primary
Secondary
False Positive Tuberculosis Test Other Serious 47 Male 205 lb 3/30/2006 Other Health Professional Germany
Primary
Concomitant
Skin Exfoliation Other Serious 1/1/2005 Female 163 lb 4/13/2006 Physician United States
Primary
Secondary
Concomitant
Ventricular Hypoplasia Other Serious 10/1/2005 33 Female 106 lb 4/25/2006 Physician France
Primary
Secondary
Grand Mal Convulsion Other Serious 3/25/2006 62 Male 168 lb 5/4/2006
Primary
Concomitant
Photosensitivity Reaction Other Serious 5/3/2006 88 Female 6/1/2006
Primary
Concomitant
Vomiting Hospitalization 4/21/2006 57 Female 130 lb 6/22/2006 Other Health Professional United Kingdom
Primary
Concomitant
Rhabdomyolysis Life Threatening 3/1/2006 64 Female 265 lb 6/28/2006 Physician Germany
Primary
Concomitant
Rhabdomyolysis Life Threatening 3/1/2006 64 Female 265 lb 6/28/2006 Physician Germany
Primary
Concomitant
Gastritis Hospitalization 7/11/2006 Female 137 lb 7/28/2006 Physician Chile
Primary
Concomitant
Scleritis Hospitalization 11/1/2004 65 Female 110 lb 8/15/2006 Physician France
Primary
Secondary
Concomitant
Toe Amputation Hospitalization 3/15/2005 72 Female 8/24/2006
Primary
Concomitant
Pneumocystis Jiroveci Pneumonia Hospitalization 8/22/2006 51 Male 9/26/2006 Physician Belgium
Primary
Concomitant
Suicidal Ideation Hospitalization 7/31/2006 63 Female 10/4/2006 Other Health Professional France
Primary
Secondary
Liver Function Test Abnormal Other Serious 9/16/2006 75 Female 143 lb 10/25/2006 Physician Australia
Primary
Concomitant
Weight Decreased Other Serious 5/1/2005 60 Male 143 lb 11/8/2006 Physician France
Primary
Concomitant
Cardiac Arrest Other Serious 9/8/2006 68 Male 11/9/2006
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 10/23/2006 25 Female 11/16/2006 Pharmacist United Kingdom
Primary
Concomitant
Liver Function Test Abnormal Other Serious 9/16/2006 75 Female 143 lb 11/27/2006 Physician Australia
Primary
Concomitant
Lymphocytosis Hospitalization 7/27/2006 53 Female 12/15/2006 Other Health Professional France
Primary
Secondary
Lymphocytosis Hospitalization 7/27/2006 53 Female 12/18/2006 Other Health Professional France
Primary
Secondary
Concomitant
Haemorrhage 36 Female 12/22/2006 Physician Brazil
Primary
Secondary
Drug Exposure During Pregnancy 11/1/2005 34 Female 12/26/2006 Physician Italy
Primary
Secondary
Fatigue Other Serious 10/12/2006 74 Male 12/29/2006 Physician United States
Primary
Secondary
Concomitant
Leg Amputation Hospitalization 11/20/2006 83 Female 1/22/2007 Consumer Spain
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/1/2006 65 Female 137 lb 2/8/2007 Pharmacist Netherlands
Primary
Secondary
Concomitant
Vertigo Other Serious 12/29/2006 83 Female 169 lb 2/9/2007
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/1/2006 65 Female 137 lb 2/16/2007 Pharmacist Netherlands
Primary
Secondary
Concomitant
Rheumatoid Arthritis Other Serious 56 Female 2/23/2007 Physician France
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/1/2006 65 Female 137 lb 3/29/2007 Pharmacist Netherlands
Primary
Secondary
Concomitant
Skin Necrosis Hospitalization 3/15/2005 72 Female 4/12/2007 France
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/1/2006 65 Female 137 lb 4/18/2007 Pharmacist Netherlands
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/6/2006 52 Female 4/19/2007 Physician Netherlands
Primary
Concomitant
Pneumonia Hospitalization 4/1/2007 Male 4/20/2007 Pharmacist Australia
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 1/12/2007 47 Female 4/24/2007
Primary
Concomitant
Vomiting Hospitalization 10/6/2006 52 Female 198 lb 4/24/2007 Physician Netherlands
Primary
Concomitant
Metrorrhagia Other Serious 1/1/2005 33 Female 5/7/2007 Physician France
Primary
Secondary
Ventricular Hypoplasia Other Serious 3/1/2006 0 Male 4 lb 5/8/2007 France
Primary
Secondary
Ventricular Hypoplasia Other Serious 3/1/2006 0 Male 4 lb 5/9/2007 France
Primary
Secondary
Skin Necrosis Hospitalization 3/15/2005 72 Female 5/24/2007 France
Primary
Concomitant
Gastritis Hospitalization 7/11/2006 Female 137 lb 6/21/2007 Physician Chile
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 10/19/2006 25 Female 132 lb 7/2/2007 Pharmacist United Kingdom
Primary
Concomitant
Hepatic Function Abnormal Hospitalization 11/1/2006 65 Female 137 lb 7/24/2007 Pharmacist Netherlands
Primary
Secondary
Concomitant
Presyncope Hospitalization 6/18/2007 57 Male 8/7/2007
Primary
Concomitant
Presyncope Hospitalization 6/18/2007 57 Male 8/13/2007
Primary
Concomitant
Drug Exposure During Pregnancy Female 8/20/2007 Consumer Argentina
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 10/19/2006 25 Female 132 lb 8/28/2007 Pharmacist United Kingdom
Primary
Concomitant
Thrombotic Thrombocytopenic Purpura Hospitalization 7/1/2007 Female 8/31/2007 Pharmacist United Kingdom
Primary
Concomitant
Nausea Other Serious 11/1/2006 57 Female 9/6/2007 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Hypertension Life Threatening 6/27/2005 71 Female 9/10/2007 Physician South Africa
Primary
Concomitant
Transaminases Increased Hospitalization 7/1/2007 72 Female 9/21/2007 Physician Spain
Primary
Concomitant
Tuberculosis Life Threatening 6/27/2005 71 Female 9/25/2007 Physician South Africa
Primary
Concomitant
Gastroenteritis Norwalk Virus Hospitalization 1/1/2007 Female 161 lb 9/28/2007 Physician Germany
Primary
Secondary
Concomitant
Mixed Hepatocellular-cholestatic Injury Hospitalization 8/31/2007 86 Female 10/8/2007
Primary
Secondary
Concomitant
Transaminases Increased Hospitalization 7/1/2007 72 Female 10/9/2007 Physician Spain
Primary
Concomitant
Mixed Hepatocellular-cholestatic Injury Hospitalization 8/23/2007 86 Female 10/12/2007 Consumer France
Primary
Secondary
Concomitant
Coccidioidomycosis Other Serious 8/7/2007 Male 106 lb 10/29/2007 Physician United States
Primary
Concomitant
Pulmonary Hypertension Life Threatening 6/27/2005 71 Female 10/31/2007 Physician South Africa
Primary
Concomitant
Drug Exposure During Pregnancy Other Serious 10/1/2007 24 Female 134 lb 11/13/2007 Physician Brazil
Primary
Secondary
Concomitant
Pancytopenia Other Serious 6/6/2007 86 Female 11/21/2007
Primary
Secondary
Concomitant
Abortion Induced 10/1/2007 32 Female 11/26/2007 Physician United Kingdom
Primary
Concomitant
Transaminases Increased Hospitalization 7/1/2007 72 Female 11/30/2007 Physician Spain
Primary
Concomitant
Pruritus Other Serious 3/1/2007 60 Female 12/6/2007 Physician France
Primary
Concomitant
Sinus Congestion 12/1/2006 Male 12/11/2007 Physician United States
Primary
Secondary
Concomitant
Pneumonia Other Serious Male 12/20/2007 Physician
Primary
Concomitant
Pneumonia Other Serious Male 12/21/2007 Physician
Primary
Concomitant
Spinal Compression Fracture Hospitalization 10/1/2007 72 Female 12/24/2007 Consumer Brazil
Primary
Concomitant
Spinal Compression Fracture Hospitalization 10/1/2007 72 Female 1/2/2008 Physician Brazil
Primary
Concomitant
Tuberculosis Of Central Nervous System Hospitalization 12/1/2007 Female 1/17/2008 Physician United States
Primary
Concomitant
Lymphocyte Count Decreased Other Serious 1/21/2008 Male 2/1/2008 Consumer Argentina
Primary
Concomitant
Neuropathy Peripheral Hospitalization 2/4/2007 73 Female 2/15/2008 Physician Spain
Primary
Concomitant
Neuropathy Peripheral Hospitalization 2/4/2007 73 Female 2/27/2008 Physician Spain
Primary
Concomitant
Pruritus Other Serious 3/1/2007 60 Female 110 lb 2/28/2008 Physician France
Primary
Secondary
Concomitant
Neuropathy Peripheral Hospitalization 2/4/2007 73 Female 3/5/2008 Physician Spain
Primary
Concomitant
Neuropathy Peripheral Hospitalization 2/4/2007 73 Female 3/19/2008 Physician Spain
Primary
Concomitant
Neuropathy Peripheral Hospitalization 2/4/2007 73 Female 4/1/2008 Physician Spain
Primary
Concomitant
Drug Exposure During Pregnancy Female 5/27/2008 Consumer Argentina
Primary
Concomitant
Septic Shock Hospitalization Male 5/28/2008 Other Health Professional United Kingdom
Primary
Concomitant
Neuropathy Peripheral Hospitalization 2/4/2007 73 Female 5/29/2008 Physician Spain
Primary
Concomitant
Medication Error Hospitalization 4/26/2008 14 Male 7/10/2008
Primary
Secondary
Concomitant
Malaise Other Serious 3/1/2008 61 Male 7/14/2008 Physician Hungary
Primary
Concomitant
Toxic Epidermal Necrolysis Life Threatening 10/20/2006 25 Female 132 lb 7/15/2008 Pharmacist United Kingdom
Primary
Concomitant
Retinal Haemorrhage Other Serious 8/1/2006 49 Female 7/18/2008
Primary
Concomitant
Gamma-glutamyltransferase Increased Other Serious 12/18/2007 57 Female 143 lb 7/21/2008 Physician Poland
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 12/18/2007 57 Female 143 lb 7/23/2008 Physician Poland
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 12/18/2007 57 Female 143 lb 7/30/2008 Physician Poland
Primary
Concomitant
Haemorrhoidal Haemorrhage Hospitalization 7/26/2008 68 Female 8/13/2008 Consumer Spain
Primary
Concomitant
Alanine Aminotransferase Increased Other Serious 12/18/2007 57 Female 143 lb 8/22/2008 Physician Poland
Primary
Concomitant
Pyrexia Other Serious 1/24/2007 60 Female 190 lb 9/12/2008 Other Health Professional Finland
Primary
Secondary
Concomitant
Pancytopenia Other Serious 12/3/2005 60 Male 99 lb 9/24/2008 Physician Japan
Primary
Concomitant
Polyneuropathy Disability 1/1/2008 Female 9/24/2008 Physician Finland
Primary
Concomitant
Interacting
Haematoma Hospitalization 9/13/2008 37 Female 101 lb 9/26/2008 Physician Germany
Primary
Concomitant
Drug Exposure During Pregnancy 35 Female 10/16/2008 Other Health Professional United Kingdom
Primary
Concomitant
Polyneuropathy Disability 1/1/2008 Female 11/4/2008 Physician Finland
Primary
Concomitant
Interacting
Drug Exposure During Pregnancy 6/14/2007 35 Female 11/24/2008 Other Health Professional United Kingdom
Primary
Concomitant
Chest Pain Hospitalization 11/12/2008 60 Female 11/26/2008 Consumer Colombia
Primary
Concomitant
Chest Pain Hospitalization 11/12/2008 60 Female 12/2/2008 Consumer Colombia
Primary
Concomitant
Pruritus Other Serious 2/28/2008 57 Male 12/9/2008 Physician Czech Republic
Primary
Concomitant
Throat Tightness Other Serious 10/24/2008 66 Female 12/11/2008 Other Health Professional United Kingdom
Primary
Concomitant
Pruritus Other Serious 2/28/2008 57 Male 12/11/2008 Physician Czech Republic
Primary
Concomitant
Jaundice Hospitalization 3/1/2008 74 Female 12/12/2008 Pharmacist Spain
Primary
Secondary
Concomitant
Nausea Hospitalization 12/2/2008 Female 12/15/2008 Physician Germany
Primary
Concomitant
Drug Exposure During Pregnancy 6/14/2007 35 Female 12/19/2008 Other Health Professional United Kingdom
Primary
Concomitant
Cholecystitis Other Serious 12/10/2008 70 Female 12/29/2008 Consumer Australia
Primary
Secondary
Concomitant
Nausea Hospitalization 12/2/2008 Female 1/7/2009 Physician Germany
Primary
Concomitant
Poisoning Hospitalization 6/1/2008 Female 130 lb 1/8/2009 Canada
Primary
Concomitant
Sepsis Hospitalization 6/1/2008 Female 130 lb 1/9/2009 Canada
Primary
Concomitant
Knee Arthroplasty Hospitalization 9/22/2008 Male 243 lb 1/16/2009 Germany
Primary
Concomitant
Skin Laceration Hospitalization 5/11/2008 Male 160 lb 2/12/2009 Consumer United States
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 11/1/2008 Female 2/16/2009 Brazil
Primary
Concomitant
Tuberculosis Hospitalization 7/7/2008 33 Female 2/17/2009 Physician Spain
Primary
Secondary
Concomitant
Sepsis Hospitalization 6/1/2008 Female 130 lb 2/19/2009 Canada
Primary
Concomitant
Pulmonary Embolism Hospitalization 76 Male 2/25/2009 Pharmacist Germany
Primary
Secondary
Streptococcal Infection Other Serious 1/1/2005 Female 135 lb 3/4/2009 Physician United States
Primary
Secondary
Concomitant
Cholecystitis Other Serious 11/7/2008 70 Female 3/4/2009 Consumer New Zealand
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 11/1/2008 Female 119 lb 3/6/2009 Brazil
Primary
Concomitant
Anaemia Hospitalization Female 3/9/2009 Brazil
Primary
Secondary
Concomitant
Ovarian Neoplasm Other Serious 10/1/2008 Female 150 lb 3/16/2009 United States
Primary
Concomitant
Cholecystitis Other Serious 11/7/2008 70 Female 3/24/2009 Consumer New Zealand
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 2/16/2009 57 Female 3/24/2009 Physician Italy
Primary
Secondary
Concomitant
Paternal Drugs Affecting Foetus 24 Female 4/30/2009 Pharmacist United Kingdom
Primary
Secondary
Concomitant
Lipomatosis Hospitalization 1/1/2006 45 Male 7/2/2009 Physician Spain
Primary
Concomitant
Weight Decreased Other Serious 83 Female 7/17/2009 Australia
Primary
Secondary
Concomitant
Vomiting Death 7/18/2009 57 Male 128 lb 7/31/2009 Physician Colombia
Primary
Concomitant
Pneumonia Other Serious 7/25/2009 Female 150 lb 8/7/2009 Brazil
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 68 Female 8/10/2009 United States
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 68 Female 8/13/2009 Consumer United States
Primary
Concomitant
Skin Ulcer Hospitalization 1/1/2004 71 Female 132 lb 8/19/2009 Physician Slovenia
Primary
Concomitant
Vomiting Hospitalization 1/1/2009 75 Female 8/21/2009 Consumer Spain
Primary
Concomitant
Dyspepsia Other Serious Male 148 lb 8/24/2009 Brazil
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 68 Female 8/23/2009 Lawyer United States
Primary
Concomitant
Pneumonia Other Serious 3/27/2009 Female 150 lb 9/3/2009 Brazil
Primary
Concomitant
Ultrasound Antenatal Screen 8/14/2009 35 Female 117 lb 9/4/2009 Consumer Brazil
Primary
Concomitant
Sjogren's Syndrome Hospitalization 1/1/2009 57 Female 187 lb 9/4/2009 Physician Netherlands
Primary
Concomitant
Fall Other Serious Male 9/11/2009 Brazil
Primary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 68 Female 9/17/2009 United States
Primary
Concomitant
Squamous Cell Carcinoma Other Serious 8/7/2009 Female 192 lb 10/9/2009 Physician United States
Primary
Secondary
Concomitant
Foot Fracture Other Serious 7/12/2009 Female 128 lb 10/15/2009 Brazil
Primary
Concomitant
Dyspnoea Hospitalization 9/19/2009 62 Female 11/6/2009 Consumer Germany
Primary
Concomitant
Wound Haemorrhage Other Serious 10/1/2008 Female 150 lb 11/16/2009 United States
Primary
Concomitant
Pneumonia Other Serious 3/27/2009 Female 150 lb 11/17/2009 Brazil
Primary
Concomitant

Drug Data