Blinded: Placebo combined with Metformin Hcl

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Weight Decreased Other Serious 3/12/2006 80 Female 10/6/2006 Consumer France
Primary
Secondary
Concomitant
Renal Failure Hospitalization 10/15/2005 79 Female 10/27/2006 Other Health Professional Argentina
Primary
Secondary
Concomitant
Lung Carcinoma Cell Type Unspecified Recurrent Other Serious 12/11/2006 53 Female 1/23/2007 Consumer United States
Primary
Concomitant
Interacting
Pancreatitis Acute Hospitalization 4/4/2007 63 Female 4/17/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 4/4/2007 63 Female 5/2/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Toxic Skin Eruption Hospitalization 5/1/2007 54 Male 5/18/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 10/11/2006 46 Male 5/25/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Chest Discomfort Hospitalization 4/30/2007 39 Female 5/25/2007 Other Health Professional Germany
Primary
Secondary
Toxic Skin Eruption Hospitalization 5/1/2007 54 Male 6/6/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Chest Pain Hospitalization 4/30/2007 39 Female 6/6/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Chest Pain Hospitalization 4/30/2007 39 Female 7/6/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/18/2007 59 Female 209 lb 7/31/2007 Other Health Professional France
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 2/8/2007 64 Female 8/14/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/18/2007 59 Female 209 lb 9/5/2007 Other Health Professional France
Primary
Secondary
Concomitant
Chest Pain Hospitalization 63 Female 9/12/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 4/4/2007 63 Female 10/10/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Failure Hospitalization 4/18/2007 59 Female 209 lb 11/15/2007 Other Health Professional France
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 11/6/2007 46 Male 11/30/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 2/8/2008 56 Male 2/13/2008 Consumer Singapore
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 2/8/2008 56 Male 2/15/2008 Consumer Singapore
Primary
Secondary
Concomitant
Diabetes Mellitus Hospitalization 1/29/2008 61 Female 4/15/2008 Consumer Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/17/2008 54 Male 163 lb 5/16/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Gastritis Hospitalization 3/10/2008 62 Female 5/22/2008 Consumer Singapore
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/17/2008 54 Male 163 lb 5/29/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Gastritis Hospitalization 3/10/2008 62 Female 6/19/2008 Consumer Singapore
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/12/2008 39 Male 128 lb 7/1/2008 Consumer Germany
Primary
Secondary
Gastritis Hospitalization 3/10/2008 62 Female 7/21/2008 Consumer Singapore
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 3/13/2008 58 Female 123 lb 7/28/2008 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Gastritis Hospitalization 3/10/2008 62 Female 7/29/2008 Consumer Singapore
Primary
Secondary
Concomitant
Varices Oesophageal Hospitalization 7/8/2008 58 Male 212 lb 7/30/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Varices Oesophageal Hospitalization 7/8/2008 58 Male 207 lb 8/6/2008 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 5/20/2008 57 Female 110 lb 9/15/2008 Other Health Professional Germany
Primary
Secondary
Concomitant
Cryptogenic Cirrhosis Hospitalization 7/8/2008 58 Male 207 lb 11/5/2008 Consumer United States
Primary
Secondary
Concomitant
Cryptogenic Cirrhosis Hospitalization 7/8/2008 58 Male 207 lb 11/19/2008 Consumer United States
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 10/16/2008 56 Female 165 lb 11/21/2008 Other Health Professional Sweden
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 11/7/2008 66 Female 11/21/2008 Other Health Professional South Africa
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 11/7/2008 66 Female 11/26/2008 Other Health Professional South Africa
Primary
Secondary
Concomitant
Hepatitis Other Serious 12/3/2008 32 Male 205 lb 12/16/2008 Other Health Professional India
Primary
Secondary
Concomitant
Creatinine Renal Clearance Decreased Other Serious 12/3/2008 65 Male 12/19/2008 Other Health Professional Argentina
Primary
Secondary
Concomitant
Hepatitis Other Serious 12/3/2008 32 Male 205 lb 12/24/2008 Other Health Professional India
Primary
Secondary
Concomitant
Creatinine Renal Clearance Decreased Other Serious 12/3/2008 65 Male 1/2/2009 Other Health Professional Argentina
Primary
Secondary
Concomitant
Hepatitis Other Serious 12/3/2008 32 Male 205 lb 1/8/2009 Other Health Professional India
Primary
Secondary
Concomitant
Creatinine Renal Clearance Decreased Other Serious 12/3/2008 65 Male 1/16/2009 Other Health Professional Argentina
Primary
Secondary
Concomitant
Gastritis Hospitalization 2/6/2009 65 Female 2/11/2009 Consumer Singapore
Primary
Secondary
Hypoglycaemia Other Serious 1/18/2008 59 Female 2/20/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Pyelonephritis Other Serious 1/19/2009 46 Male 2/23/2009 Consumer Russian Federation
Primary
Secondary
Concomitant
Abdominal Pain Life Threatening 2/6/2009 65 Female 3/16/2009 Consumer Singapore
Primary
Secondary
Chest Pain Hospitalization 3/2/2009 65 Male 3/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Chest Pain Hospitalization 3/2/2009 65 Male 3/27/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Prostate Cancer Other Serious 3/5/2009 60 Male 4/2/2009 Other Health Professional Argentina
Primary
Secondary
Concomitant
Prostate Cancer Other Serious 3/18/2009 60 Male 5/14/2009 Other Health Professional Argentina
Primary
Secondary
Concomitant
Arteriosclerosis Coronary Artery Other Serious 3/2/2009 65 Male 5/15/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 12/16/2008 69 Male 7/23/2009 Other Health Professional Argentina
Primary
Secondary
Concomitant
Gastrointestinal Obstruction Other Serious 2/6/2009 65 Female 9/21/2009 Consumer Singapore
Primary
Secondary
Hepatitis Toxic Other Serious 7/16/2009 62 Female 9/30/2009 Consumer Brazil
Primary
Secondary
Concomitant
Hepatitis Toxic Other Serious 7/16/2009 62 Female 11/18/2009 Consumer Brazil
Primary
Secondary
Concomitant
Hepatitis Toxic Other Serious 7/16/2009 62 Female 11/23/2009 Consumer Brazil
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 12/16/2008 69 Male 1/20/2010 Other Health Professional Argentina
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 12/16/2008 69 Male 1/22/2010 Other Health Professional Argentina
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 12/21/2009 67 Female 187 lb 3/4/2010 United States
Primary
Secondary
Concomitant
Hepatitis Toxic Other Serious 7/16/2009 62 Female 3/9/2010 Consumer Brazil
Primary
Secondary
Concomitant
Anaemia Hospitalization 12/15/2009 75 Male 3/18/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Hospitalization 12/15/2009 75 Male 3/22/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Hepatitis Toxic Other Serious 7/16/2009 62 Female 4/5/2010 Consumer Brazil
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 7/3/2010 69 Male 7/19/2010 Other Health Professional United States
Primary
Secondary
Vomiting Hospitalization 8/10/2009 76 Male 146 lb 8/9/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 12/21/2009 67 Female 187 lb 8/11/2010 United States
Primary
Secondary
Concomitant
Hepatitis Toxic Other Serious 7/16/2009 62 Female 8/25/2010 Consumer Brazil
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 7/3/2010 69 Male 9/14/2010 Other Health Professional United States
Primary
Secondary
Pulmonary Tuberculosis Other Serious 8/2/2010 51 Female 9/30/2010 Other Health Professional Peru
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Other Serious 8/2/2010 51 Female 10/11/2010 Other Health Professional Peru
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 7/3/2010 69 Male 10/24/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 9/20/2010 70 Female 10/31/2010 Consumer Hungary
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 9/27/2010 75 Female 12/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 11/24/2010 51 Male 12/6/2010 Other Health Professional Israel
Primary
Secondary
Concomitant
Renal Cyst Hospitalization 11/25/2010 51 Male 12/12/2010 Other Health Professional Israel
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/27/2010 75 Female 12/13/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Organ Failure Hospitalization 11/12/2010 65 Male 12/13/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 9/20/2010 70 Female 12/13/2010 Consumer Hungary
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 9/20/2010 70 Female 12/16/2010 Consumer Hungary
Primary
Secondary
Concomitant
Organ Failure Hospitalization 11/12/2010 65 Male 12/21/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Cognitive Disorder Hospitalization 9/27/2010 75 Female 1/28/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Toxicity To Various Agents Hospitalization 1/14/2011 70 Female 2/1/2011 Consumer United States
Primary
Secondary
Concomitant
Mental Impairment Hospitalization 9/27/2010 75 Female 2/2/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Hospitalization 12/21/2010 61 Male 2/8/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Organ Failure Death 11/12/2010 65 Male 2/9/2011 Consumer United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 12/4/2010 68 Male 2/15/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 12/21/2010 61 Male 2/15/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Abdominal Pain Upper Other Serious 12/4/2010 68 Male 3/1/2011 Consumer Germany
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 9/20/2010 70 Female 3/4/2011 Other Health Professional Hungary
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 12/4/2010 68 Male 3/4/2011 Consumer Germany
Primary
Secondary
Concomitant
Rash Maculovesicular Other Serious 2/17/2011 56 Male 3/4/2011 Other Health Professional Australia
Primary
Secondary
Concomitant
Abdominal Pain Upper Hospitalization 12/4/2010 68 Male 3/14/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Herpes Zoster Other Serious 2/17/2011 56 Male 3/16/2011 Consumer Australia
Primary
Secondary
Concomitant
Herpes Zoster Multi-dermatomal Other Serious 2/16/2011 76 Male 3/18/2011 Other Health Professional Sweden
Primary
Secondary
Concomitant
Asthma Hospitalization 2/9/2011 64 Female 3/30/2011 Consumer United States
Primary
Secondary
Concomitant
Urticaria Hospitalization 2/9/2011 64 Female 4/5/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Chronic Hospitalization 2/9/2011 64 Female 4/11/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 3/29/2011 67 Male 4/13/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 3/30/2011 71 Male 4/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Syncope Other Serious 74 Female 4/26/2011 Consumer United States
Primary
Secondary
Hypoglycaemia 3/30/2011 71 Male 4/27/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Chronic Hospitalization 2/9/2011 64 Female 234 lb 5/3/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 6/15/2011 82 Male 6/24/2011 Consumer United States
Primary
Secondary
Concomitant
Appendicitis Hospitalization 7/23/2011 81 Female 8/1/2011 Consumer Sweden
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/11/2011 61 Female 8/5/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Ascites Hospitalization 7/2/2011 60 Male 8/12/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 1/11/2011 68 Male 8/24/2011 Consumer United States
Primary
Secondary
Concomitant
Ascites Death 7/2/2011 60 Male 9/8/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Acute Death 7/2/2011 60 Male 9/20/2011 Other Health Professional France
Primary
Secondary
Concomitant
Pericardial Haemorrhage Death 1/14/2011 70 Female 9/23/2011 Consumer United States
Primary
Secondary
Concomitant
Retroperitoneal Neoplasm Other Serious 8/24/2011 69 Male 130 lb 9/26/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Nausea Death 7/2/2011 60 Male 9/28/2011 Other Health Professional France
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 8/8/2011 75 Male 9/29/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Haematuria Hospitalization 7/2/2011 60 Male 9/29/2011 Consumer France
Primary
Secondary
Concomitant
Cognitive Disorder Hospitalization 9/27/2010 75 Female 9/29/2011 Consumer United States
Primary
Secondary
Concomitant
Haematuria Other Serious 7/2/2011 60 Male 9/30/2011 Consumer France
Primary
Secondary
Concomitant
Infectious Peritonitis Hospitalization 8/24/2011 69 Male 130 lb 9/30/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 7/14/2011 57 Female 10/4/2011 Consumer United States
Primary
Secondary
Renal Impairment Hospitalization 8/30/2011 74 Female 10/9/2011 Consumer United States
Primary
Secondary
Concomitant
Ascites Other Serious 7/2/2011 60 Male 10/11/2011 Consumer France
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 11/30/2010 60 Female 10/11/2011 Consumer United States
Primary
Secondary
Dehydration Hospitalization 8/30/2011 74 Female 10/12/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 10/3/2011 61 Female 10/19/2011 Consumer United States
Primary
Secondary
Mental Status Changes Hospitalization 9/27/2010 75 Female 10/19/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 9/5/2011 60 Female 10/19/2011 Other Health Professional United States
Primary
Secondary
Concomitant
International Normalised Ratio Increased Hospitalization 1/14/2011 70 Female 10/21/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 10/1/2011 61 Male 10/21/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 10/3/2011 61 Female 10/25/2011 Other Health Professional United States
Primary
Secondary
Pancreatitis Chronic Hospitalization 2/9/2011 64 Female 234 lb 10/25/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 9/5/2011 60 Female 10/26/2011 Consumer United States
Primary
Secondary
Concomitant
Duodenal Ulcer Perforation Hospitalization 10/1/2011 61 Male 11/2/2011 Consumer United States
Primary
Secondary
Concomitant
Quadriparesis Life Threatening 11/2/2011 75 Male 11/7/2011 Consumer Hungary
Primary
Secondary
Concomitant
Visual Impairment Hospitalization 1/2/2011 63 Female 11/8/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Pancreatitis Acute Life Threatening 1/11/2011 68 Male 11/10/2011 Consumer United States
Primary
Secondary
Concomitant
Retroperitoneal Neoplasm Other Serious 8/24/2011 69 Male 130 lb 11/14/2011 Consumer United States
Primary
Secondary
Concomitant
Hyperkalaemia Other Serious 11/2/2011 75 Male 11/15/2011 Consumer Hungary
Primary
Secondary
Concomitant
Jaundice Other Serious 8/30/2011 73 Male 11/16/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 11/30/2010 60 Female 11/16/2011 Consumer United States
Primary
Secondary
Cholecystitis Acute Hospitalization 1/1/2011 73 Female 11/17/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatic Carcinoma Metastatic Hospitalization 8/30/2011 73 Male 11/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Duodenal Ulcer Perforation Hospitalization 10/1/2011 61 Male 11/23/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 11/22/2010 62 Male 331 lb 11/23/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 11/22/2010 62 Male 331 lb 11/24/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 8/8/2011 75 Male 11/29/2011 Consumer United States
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 12/5/2010 68 Female 11/30/2011 Consumer United States
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Hospitalization 6/3/2011 50 Male 12/1/2011 Other Health Professional United States
Primary
Secondary
Pancreatitis Acute Hospitalization 12/5/2010 68 Female 12/1/2011 Consumer United States
Primary
Secondary
Concomitant
Oesophageal Candidiasis Hospitalization 2/3/2011 42 Male 12/13/2011 Other Health Professional Mexico
Primary
Secondary
Concomitant
Mental Status Changes Hospitalization 9/27/2010 75 Female 12/13/2011 Consumer United States
Primary
Secondary
Concomitant

Drug Data