Omeprazole combined with Placebo

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Urinary Retention Other Serious 8/15/2005 Male 1/5/2006 United Kingdom
Primary
Secondary
Concomitant
Haematuria Other Serious 2/8/2005 Male 2/1/2006 Physician Spain
Primary
Secondary
Concomitant
Neutropenia Hospitalization 2/13/2005 68 Female 148 lb 2/8/2006 Physician Spain
Primary
Secondary
Concomitant
Gastritis Hospitalization 11/27/2002 72 Female 137 lb 4/7/2006 Physician Poland
Primary
Secondary
Concomitant
Gastritis Hospitalization 11/27/2002 72 Female 137 lb 5/5/2006 Physician Poland
Primary
Secondary
Concomitant
Splenectomy Hospitalization 9/26/1999 Male 130 lb 5/18/2006 Physician Sweden
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 4/19/2006 Male 148 lb 5/31/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 4/19/2006 Male 148 lb 6/14/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Haemorrhagic Stroke Life Threatening 9/4/2006 Male 148 lb 9/28/2006 Physician Bulgaria
Primary
Secondary
Concomitant
Haemorrhagic Stroke Life Threatening 9/4/2006 Male 148 lb 10/6/2006 Physician Bulgaria
Primary
Secondary
Concomitant
Haemorrhagic Stroke Life Threatening 9/4/2006 Male 148 lb 10/11/2006 Physician Bulgaria
Primary
Secondary
Concomitant
Splenectomy Hospitalization 9/26/1999 Male 130 lb 2/5/2007 Physician Sweden
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 3/1/2007 Male 163 lb 6/1/2007 Physician Canada
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 3/1/2007 Male 163 lb 6/1/2007 Physician Canada
Primary
Secondary
Concomitant
Febrile Neutropenia Hospitalization 5/9/2006 67 Female 8/10/2007 United States
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
Haemorrhagic Stroke Life Threatening 9/4/2006 Male 148 lb 8/15/2007 Physician Bulgaria
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Death 7/4/2006 75 Female 3/5/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 3/13/2008 59 Female 142 lb 4/1/2008 Other Health Professional Belgium
Primary
Secondary
Concomitant
Thoracic Vertebral Fracture Hospitalization 1/3/2008 83 Female 4/8/2008 Physician Belgium
Primary
Concomitant
Panniculitis Hospitalization 4/29/2008 Female 141 lb 5/12/2008 Physician Portugal
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/1/2008 73 Male 196 lb 5/21/2008 Other Health Professional Spain
Primary
Secondary
Concomitant
Panniculitis Hospitalization 4/29/2008 Female 141 lb 5/16/2008 Physician Portugal
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/1/2008 73 Male 196 lb 5/23/2008 Other Health Professional Spain
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 3/1/2008 73 Male 196 lb 5/23/2008 Other Health Professional Spain
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 6/4/2008 Male 192 lb 6/16/2008 Pharmacist Netherlands
Primary
Secondary
Concomitant
Vulvovaginal Candidiasis Hospitalization 11/13/2007 61 Female 170 lb 7/7/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Thrombocytopenia Hospitalization 7/22/2008 Female 126 lb 8/18/2008 Physician Spain
Primary
Secondary
Concomitant
Vomiting Hospitalization 6/6/2008 Female 195 lb 8/6/2008 Physician United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/24/2007 60 Female 190 lb 9/10/2008 Physician Finland
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/24/2007 60 Female 190 lb 9/12/2008 Other Health Professional Finland
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 9/13/2007 80 Male 9/24/2008 Other Health Professional Canada
Primary
Secondary
Concomitant
Arthralgia Hospitalization 8/27/2007 64 Male 9/24/2008 Consumer Australia
Primary
Secondary
Concomitant
Death Death 9/20/2008 Female 10/7/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Cardiac Failure Death 9/20/2008 Female 10/15/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/3/2008 57 Male 12/22/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Hypogonadism Other Serious 2/21/2009 63 Male 242 lb 4/17/2009 Physician United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 3/5/2009 64 Male 4/17/2009 Physician Poland
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
Malignant Neoplasm Progression Death 7/4/2006 75 Female 5/6/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 5/14/2009 Physician Mexico
Primary
Secondary
Concomitant
Abscess Limb Hospitalization 2/25/2009 Female 123 lb 5/19/2009 Physician Malaysia
Primary
Secondary
Concomitant
Abscess Limb Hospitalization 2/25/2009 Female 123 lb 5/19/2009 Physician Malaysia
Primary
Secondary
Concomitant
Abscess Limb Hospitalization 2/25/2009 Female 123 lb 5/20/2009 Physician Malaysia
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 6/12/2009 Male 115 lb 6/26/2009 Physician China
Primary
Secondary
Concomitant
Uterine Haemorrhage Hospitalization 1/8/2009 Female 161 lb 7/16/2009 Physician Mexico
Primary
Secondary
Concomitant
Ischaemic Stroke Other Serious 7/1/2009 61 Male 231 lb 7/17/2009 Consumer Brazil
Primary
Secondary
Concomitant
Ischaemic Stroke Other Serious 7/1/2009 61 Male 231 lb 7/23/2009 Consumer Brazil
Primary
Secondary
Concomitant
Shock Haemorrhagic Death 6/12/2009 Male 115 lb 8/10/2009 Physician China
Primary
Secondary
Concomitant
Encephalitis Hospitalization 5/21/2009 Male 8/12/2009 Physician United Kingdom
Primary
Secondary
Concomitant
Mycobacterial Infection Hospitalization 8/1/2009 Female 121 lb 8/14/2009 Physician New Zealand
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 Tract Infection Life Threatening 8/21/2009 Female 9/2/2009 Physician Argentina
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/22/2008 Female 206 lb 9/3/2009 Physician New Zealand
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 9/22/2009 Physician Argentina
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
Viral Infection Hospitalization 9/21/2009 Female 132 lb 10/5/2009 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/27/2009 67 Female 166 lb 10/6/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Soft Tissue Infection Hospitalization 8/1/2009 Female 121 lb 10/14/2009 Physician New Zealand
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 11/30/2007 Female 95 lb 10/14/2009 Physician United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 8/21/2009 Female 10/23/2009 Physician Argentina
Primary
Secondary
Concomitant
Viral Infection Hospitalization 9/21/2009 Female 132 lb 11/16/2009 Physician United States
Primary
Secondary
Concomitant
Systemic Lupus Erythematosus Other Serious 1/1/2009 Female 198 lb 11/17/2009 Physician Netherlands
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 11/20/2009 Physician Finland
Primary
Secondary
Concomitant
Lymph Node Tuberculosis Other Serious 8/29/2008 Female 121 lb 11/23/2009 Physician Mexico
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 11/23/2009 Physician Japan
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 9/18/2009 Female 132 lb 12/1/2009 Physician United States
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 12/9/2009 Physician Finland
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 12/11/2009 Physician United States
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 12/15/2009 Physician Japan
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 12/1/2009 56 Male 126 lb 12/22/2009 Physician India
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 12/1/2009 56 Male 126 lb 12/31/2009 Physician India
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 11/1/2009 Male 12/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 1/5/2010 Physician Japan
Primary
Secondary
Concomitant
Suicidal Ideation Hospitalization 12/2/2009 Female 173 lb 1/6/2010 Physician United States
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 10/20/2009 Female 114 lb 1/8/2010 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/8/2010 Physician United States
Primary
Secondary
Concomitant
Suicidal Ideation Hospitalization 12/2/2009 Female 173 lb 1/12/2010 Physician United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 10/30/2009 Female 1/23/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/26/2010 Physician United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 12/1/2009 56 Male 126 lb 1/28/2010 Physician India
Primary
Secondary
Concomitant
Pneumonia Necrotising Death 8/13/2008 49 Male 1/28/2010 Other Health Professional Mexico
Primary
Secondary
Concomitant
Death Death 9/20/2009 Female 104 lb 1/28/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2009 Female 132 lb 1/29/2010 Physician United States
Primary
Secondary
Concomitant
Myocardial Rupture Other Serious 2/22/2007 70 Male 176 lb 2/2/2010 Physician United States
Primary
Secondary
Concomitant
Haematoma Infection Other Serious 3/2/2007 Male 428 lb 2/2/2010 Physician United States
Primary
Secondary
Concomitant
Meningioma Hospitalization 9/1/2007 Male 185 lb 2/2/2010 Other Health Professional France
Primary
Secondary
Concomitant
Suicidal Ideation Hospitalization 12/2/2009 Female 173 lb 2/11/2010 Physician United States
Primary
Secondary
Concomitant
Death Death 9/20/2009 Female 104 lb 2/11/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 Male 150 lb 2/12/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Sepsis Life Threatening 12/14/2009 77 Male 152 lb 2/17/2010 Physician France
Primary
Secondary
Concomitant
Pyoderma Gangrenosum Hospitalization 10/20/2009 Female 114 lb 2/19/2010 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/9/2010 70 Female 2/19/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 Female 114 lb 2/25/2010 Physician Japan
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/9/2010 70 Female 3/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hyponatraemia Life Threatening 10/16/2008 Female 97 lb 3/15/2010 Physician Brazil
Primary
Secondary
Concomitant
Viral Infection Other Serious 1/9/2010 70 Female 3/18/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 3/8/2010 Male 295 lb 3/30/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 28 Female 114 lb 4/9/2010 Physician Japan
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 10/20/2009 28 Female 114 lb 4/15/2010 Physician Japan
Primary
Secondary
Concomitant
Cervix Carcinoma Stage Iii Hospitalization 7/17/2007 47 Female 112 lb 4/16/2010 Physician Poland
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 4/15/2010 33 Female 108 lb 4/29/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 3/8/2010 41 Male 295 lb 4/30/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 11/8/2009 28 Female 114 lb 4/30/2010 Physician Japan
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 81 Male 150 lb 5/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 81 Male 150 lb 5/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 3/9/2009 77 Male 141 lb 5/7/2010 Physician United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 4/15/2010 33 Female 108 lb 5/11/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Somnolence Hospitalization 11/1/2009 69 Male 5/11/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Narcotic Intoxication Other Serious 12/29/2009 81 Male 150 lb 5/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Urinary Tract Infection 4/15/2010 33 Female 108 lb 5/21/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 12/2/2009 51 Female 173 lb 5/25/2010 Physician United States
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 11/8/2009 28 Female 114 lb 5/27/2010 Physician Japan
Primary
Secondary
Concomitant
Fatigue Hospitalization 4/25/2010 49 Male 119 lb 5/28/2010 Physician Germany
Primary
Secondary
Concomitant
Fatigue Hospitalization 4/25/2010 49 Male 119 lb 6/1/2010 Physician Italy
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 3/30/2010 57 Female 218 lb 6/1/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 5/24/2010 64 Male 151 lb 6/4/2010 Physician Spain
Primary
Secondary
Concomitant
Pneumonia Hospitalization 4/6/2010 60 Female 175 lb 6/11/2010 Physician Ukraine
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 5/24/2010 64 Male 151 lb 6/14/2010 Physician Spain
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 11/1/2009 69 Male 6/15/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 5/24/2010 64 Male 151 lb 6/18/2010 Physician Spain
Primary
Secondary
Concomitant
Sepsis Hospitalization 4/26/2010 61 Female 139 lb 6/21/2010 Physician Poland
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 4/22/2008 39 Female 206 lb 6/22/2010 Physician New Zealand
Primary
Secondary
Concomitant
Bronchopneumonia Life Threatening 4/10/2010 65 Female 180 lb 6/25/2010 Physician Poland
Primary
Secondary
Concomitant
Periorbital Cellulitis Hospitalization 6/6/2010 66 Female 121 lb 6/25/2010 Physician New Zealand
Primary
Secondary
Concomitant
Sepsis Hospitalization 4/26/2010 61 Female 139 lb 7/2/2010 Physician Poland
Primary
Secondary
Concomitant
Hypothermia Hospitalization 10/15/2008 68 Female 7/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Bronchopneumonia Life Threatening 4/10/2010 65 Female 180 lb 7/15/2010 Physician Poland
Primary
Secondary
Concomitant
Post Procedural Complication Hospitalization 12/21/2009 59 Female 104 lb 7/23/2010 Physician Brazil
Primary
Secondary
Concomitant
Colon Cancer Other Serious 7/15/2010 52 Female 173 lb 7/30/2010 Physician Germany
Primary
Secondary
Concomitant
Colon Cancer Other Serious 7/15/2010 52 Female 173 lb 8/10/2010 Physician Germany
Primary
Secondary
Concomitant
Cellulitis Hospitalization 7/12/2010 53 Female 207 lb 8/13/2010 Physician Spain
Primary
Secondary
Concomitant
Colon Cancer Other Serious 7/15/2010 52 Female 173 lb 8/19/2010 Physician Germany
Primary
Secondary
Concomitant
Cholelithiasis Hospitalization 8/3/2010 63 Female 176 lb 8/19/2010 Physician United States
Primary
Secondary
Concomitant
Perirectal Abscess Hospitalization 7/5/2010 27 Female 120 lb 8/24/2010 Physician United States
Primary
Secondary
Concomitant
Vaginal Discharge Hospitalization 7/5/2010 27 Female 120 lb 9/2/2010 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 5/30/2010 78 Male 8/31/2010 Brazil
Primary
Concomitant
Cholelithiasis Hospitalization 8/3/2010 63 Female 176 lb 9/8/2010 Physician United States
Primary
Secondary
Concomitant
Tremor Hospitalization 11/1/2009 69 Male 9/10/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/23/2010 65 Female 173 lb 9/24/2010 Physician Poland
Primary
Secondary
Concomitant
Colon Cancer Other Serious 7/15/2010 52 Female 173 lb 10/1/2010 Physician Germany
Primary
Secondary
Concomitant
Vascular Dementia Hospitalization 11/1/2009 69 Male 10/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Hospitalization 5/24/2010 64 Male 151 lb 10/5/2010 Physician Spain
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 9/9/2009 29 Male 143 lb 10/6/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Post Procedural Complication Hospitalization 12/21/2009 59 Female 104 lb 10/8/2010 Physician Brazil
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 9/29/2010 Female 175 lb 10/13/2010 Physician Mexico
Primary
Secondary
Concomitant

Drug Data