Placebo combined with Saxagliptin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Aortic Aneurysm Hospitalization 1/21/2009 Male 3/19/2009 Physician Belgium
Primary
Secondary
Pulmonary Oedema Hospitalization 9/11/2008 4/14/2009 Germany
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/11/2008 Male 5/1/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 9/11/2008 5/5/2009 Denmark
Primary
Secondary
Concomitant
Pneumonia Hospitalization 9/11/2008 Male 5/8/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 9/11/2008 72 5/29/2009 Denmark
Primary
Secondary
Concomitant
Renal Disorder Hospitalization 9/11/2008 72 Male 6/15/2009 Physician Germany
Primary
Secondary
Concomitant
Surgical Procedure Repeated Hospitalization 9/11/2008 72 Male 6/17/2009 Physician Germany
Primary
Secondary
Concomitant
Syncope Hospitalization 9/11/2008 71 Male 6/30/2009 Physician Germany
Primary
Secondary
Concomitant
Sudden Death Hospitalization 9/11/2008 71 Male 7/9/2009 Physician Germany
Primary
Secondary
Concomitant
Vomiting Hospitalization 9/11/2008 71 Male 7/10/2009 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Other Serious 9/11/2008 72 7/30/2009 Denmark
Primary
Secondary
Concomitant
Bifascicular Block Hospitalization 3/25/2009 71 Male 8/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 9/11/2008 Male 10/2/2009 Other Health Professional Denmark
Primary
Secondary
Concomitant
Hypertensive Crisis Hospitalization 8/27/2009 Female 1/19/2010 Physician Slovakia (Slovak Republic)
Primary
Concomitant
Rhabdomyolysis Other Serious 5/31/2010 45 Male 216 lb 6/20/2010 Consumer South Africa
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 5/31/2010 45 Male 216 lb 6/24/2010 Consumer South Africa
Primary
Secondary
Concomitant
Renal Impairment Other Serious 5/31/2010 45 Male 216 lb 7/23/2010 Consumer South Africa
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Other Serious 8/5/2010 66 Male 8/31/2010 Consumer Austria
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 1/6/2011 91 Female 1/13/2011 Other Health Professional United States
Primary
Secondary
Renal Impairment Hospitalization 2/5/2011 3/22/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Cellulitis Hospitalization 12/1/2010 67 Female 3/22/2011 Consumer United States
Primary
Secondary
Concomitant
Myalgia Other Serious 8/13/2010 47 Male 3/30/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Nausea Hospitalization 12/1/2010 67 Female 4/12/2011 Physician United States
Primary
Secondary
Concomitant
Psychotic Disorder Hospitalization 8/9/2010 70 Female 5/9/2011 Physician United States
Primary
Secondary
Concomitant
Psychosomatic Disease Hospitalization 8/9/2010 70 Female 5/24/2011 Physician United States
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 10/18/2009 56 Female 5/31/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 10/18/2009 56 Female 6/2/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 2/14/2000 47 Male 6/2/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 4/19/2010 66 Male 6/6/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 10/18/2009 56 Female 6/6/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Gastric Ulcer Hospitalization 10/18/2009 56 Male 6/7/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 4/14/2010 66 Male 6/8/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 4/14/2010 66 Male 6/8/2011 Other Health Professional Norway
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 6/3/2011 50 Male 6/10/2011 Consumer United States
Primary
Secondary
Hypoglycaemia Life Threatening 6/15/2011 82 Male 6/30/2011 Consumer United States
Primary
Secondary
Concomitant
Chest Discomfort Hospitalization 5/26/2011 76 Male 6/24/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 6/6/2011 63 Male 7/6/2011 Consumer Germany
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 6/6/2011 63 Male 7/8/2011 Other Health Professional Germany
Primary
Secondary
Concomitant
Overdose Life Threatening 3/4/2011 83 Male 7/11/2011 Consumer France
Primary
Secondary
Concomitant
Hypoglycaemic Coma Life Threatening 3/4/2011 83 Male 7/13/2011 Consumer France
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 6/5/2011 63 Male 7/14/2011 Other Health Professional Italy
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 5/31/2011 70 Male 7/19/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Abdominal Pain Other Serious 2/2/2011 65 Female 7/25/2011 Consumer Italy
Primary
Concomitant
Lactic Acidosis Hospitalization 7/5/2011 68 Male 8/10/2011 Physician Czech Republic
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/3/2011 82 Female 8/11/2011 Physician United States
Primary
Secondary
Concomitant
Presyncope Hospitalization 6/19/2011 66 Male 8/17/2011 Physician United States
Primary
Secondary
Concomitant
Asthma Other Serious 2/2/2011 65 Female 8/17/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Haematuria Hospitalization 6/14/2011 76 Male 8/12/2011 Consumer United States
Primary
Secondary
Concomitant
Benign Prostatic Hyperplasia Hospitalization 5/22/2011 75 Male 8/12/2011 Other Health Professional Canada
Primary
Secondary
Concomitant
Chest Pain Hospitalization 2/2/2011 65 Female 8/31/2011 Consumer Italy
Primary
Concomitant
Rectal Haemorrhage Hospitalization 7/15/2011 83 Female 9/6/2011 Physician United States
Primary
Secondary
Concomitant
Gastrointestinal Telangiectasia Hospitalization 7/15/2011 83 Female 8/26/2011 Physician United States
Primary
Secondary
Concomitant
Renal Failure Hospitalization 1/1/2011 68 Male 9/6/2011 Physician United States
Primary
Secondary
Concomitant
Gastroenteritis Hospitalization 7/5/2011 68 Male 9/9/2011 Physician Czech Republic
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 6/1/2011 57 Male 9/12/2011 Consumer United States
Primary
Secondary
Concomitant
Hypotension Life Threatening 6/30/2011 80 Male 9/18/2011 Physician United States
Primary
Secondary
Concomitant
Post Procedural Haemorrhage Hospitalization 6/30/2011 80 Male 9/20/2011 Physician United States
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 6/1/2011 57 Male 9/23/2011 Consumer United States
Primary
Secondary
Concomitant
Hyperglycaemia Hospitalization 5/31/2011 68 Male 10/21/2011 Physician United States
Primary
Concomitant
Hypoglycaemia Hospitalization 5/31/2011 70 Male 10/27/2011 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Chronic Hospitalization 5/31/2011 70 Male 10/31/2011 Consumer United States
Primary
Secondary
Concomitant
Bladder Cancer Hospitalization 9/19/2011 87 Male 11/1/2011 Other Health Professional United States
Primary
Secondary
Myocardial Ischaemia Hospitalization 5/31/2011 70 Male 11/4/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 5/31/2011 70 Male 11/8/2011 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 5/31/2011 70 Male 11/11/2011 Physician Israel
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/5/2011 11/15/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Hyperkalaemia Life Threatening 11/2/2011 75 Male 11/22/2011 Other Health Professional Hungary
Primary
Secondary
Concomitant
Syncope Hospitalization 11/3/2011 58 Male 11/23/2011 Physician United States
Primary
Secondary
Concomitant
Hypersensitivity Hospitalization 8/22/2011 64 Male 11/29/2011 Physician Germany
Primary
Secondary
Vomiting Hospitalization 69 Male 12/13/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Bradyarrhythmia Other Serious 2/4/2011 79 Female 12/16/2011 Physician Hungary
Primary
Secondary
Concomitant
Rhabdomyosarcoma Other Serious 11/24/2011 47 Male 12/23/2011 Consumer United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 10/12/2011 77 Male 1/5/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Other Serious 10/26/2011 79 Male 1/24/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Lower Gastrointestinal Haemorrhage Hospitalization 7/15/2011 83 Female 1/30/2012 Consumer United States
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 6/1/2011 57 Male 2/7/2012 Physician United States
Primary
Secondary
Concomitant
Pulmonary Tuberculosis Hospitalization 3/13/2009 68 Female 2/9/2012 Consumer Russian Federation
Primary
Secondary
Concomitant
Abdominal Distension Hospitalization 1/1/2011 61 Male 2/16/2012 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 7/30/2010 82 Male 2/24/2012 Other Health Professional United States
Primary
Secondary
International Normalised Ratio Increased Hospitalization 12/1/2010 67 Female 2/24/2012 Physician United States
Primary
Secondary
Concomitant
Interacting
Hypoglycaemia Hospitalization 6/1/2011 57 Male 2/27/2012 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 12/5/2010 67 Female 3/1/2012 Physician United States
Primary
Secondary
Concomitant
Interacting
Chest Discomfort Hospitalization 11/24/2011 81 Female 2/29/2012 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 3/4/2011 83 Male 3/2/2012 Consumer France
Primary
Secondary
Concomitant
Fall Hospitalization 5/26/2011 76 Male 2/29/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Interaction Hospitalization 12/1/2010 67 Female 3/8/2012 Physician United States
Primary
Secondary
Concomitant
Interacting
Syncope Hospitalization 11/3/2011 65 Male 3/9/2012 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 1/19/2012 75 Male 3/13/2012 Physician United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 6/1/2011 57 Male 3/21/2012 Consumer United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/17/2011 61 Male 3/22/2012 Consumer United States
Primary
Secondary
Concomitant
Syncope Hospitalization 11/3/2011 58 Male 3/27/2012 Physician United States
Primary
Secondary
Concomitant
Off Label Use Other Serious 6/6/2011 69 Male 3/27/2012 Physician United States
Primary
Secondary
Concomitant
Syncope Hospitalization 1/19/2012 75 Male 3/27/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 9/11/2011 77 Male 3/30/2012 Consumer Australia
Primary
Secondary
Gamma-glutamyltransferase Increased Other Serious 1/9/2012 75 Male 4/4/2012 Consumer United States
Primary
Concomitant
Nodal Arrhythmia Hospitalization 1/17/2012 64 Male 4/5/2012 Other Health Professional United States
Primary
Secondary
Neisseria Test Positive Hospitalization 12/16/2011 82 Male 4/18/2012 Consumer United States
Primary
Secondary
Congestive Cardiomyopathy Other Serious 6/1/2011 57 Male 4/24/2012 Consumer United States
Primary
Secondary
Concomitant
Unevaluable Event Hospitalization 12/24/2011 62 Female 4/25/2012 Consumer United States
Primary
Secondary
Interacting
Procedural Complication Hospitalization 3/19/2012 56 Male 4/25/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 11/3/2011 65 Male 5/15/2012 Physician United States
Primary
Secondary
Concomitant
Syncope Hospitalization 2/21/2012 68 Male 5/15/2012 Physician United States
Primary
Secondary
Concomitant
Burns Second Degree Life Threatening 3/31/2012 62 Male 5/15/2012 Physician United States
Primary
Secondary
Concomitant
Angina Unstable Hospitalization 6/1/2011 57 Male 5/24/2012 Physician United States
Primary
Secondary
Concomitant
Blood Creatine Phosphokinase Increased Other Serious 3/7/2012 79 Male 5/14/2012 Germany
Primary
Secondary
Concomitant
Syncope Hospitalization 2/21/2012 68 Male 5/29/2012 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/18/2012 62 Male 6/7/2012 Physician United States
Primary
Secondary
Concomitant
Blood Creatinine Increased Hospitalization 12/13/2011 68 Male 6/8/2012 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/9/2012 75 Male 6/14/2012 Consumer United States
Primary
Concomitant
Thrombocytopenia Hospitalization 9/19/2011 87 Male 6/18/2012 Other Health Professional United States
Primary
Secondary
Herpes Zoster Hospitalization 6/1/2011 57 Male 6/18/2012 Physician United States
Primary
Secondary
Concomitant
Burns Second Degree Hospitalization 3/31/2012 62 Male 6/19/2012 Consumer United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 6/22/2011 77 Female 6/19/2012 Physician United States
Primary
Secondary
Concomitant
Psychosomatic Disease Hospitalization 8/29/2010 70 Female 6/25/2012 Physician United States
Primary
Secondary
Concomitant
Hyperkalaemia Disability 3/31/2012 62 Male 7/6/2012 Physician United States
Primary
Secondary
Concomitant
Influenza Hospitalization 2/1/2012 65 Male 7/10/2012 Consumer United States
Primary
Secondary
Concomitant
Hyperkalaemia Death 4/3/2012 59 Female 7/12/2012 Other Health Professional India
Primary
Secondary
Concomitant
Chest Pain Hospitalization 2/1/2012 65 Male 7/13/2012 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 3/5/2012 56 Male 7/20/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 3/5/2012 56 Male 7/26/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/1/2012 65 Male 8/2/2012 Consumer United States
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 4/3/2012 59 Female 8/13/2012 Other Health Professional India
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/9/2012 55 Male 8/13/2012 Physician United States
Primary
Secondary
Concomitant
Microcytosis Other Serious 7/2/2012 66 Male 8/17/2012 Physician United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 8/3/2012 77 Male 8/17/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Alanine Aminotransferase Increased Other Serious 3/8/2012 56 Male 8/20/2012 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/9/2012 55 Male 8/20/2012 Physician United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 8/3/2012 77 Male 8/22/2012 Consumer United States
Primary
Secondary
Concomitant
Ulcer Hospitalization 12/5/2010 67 Female 9/20/2012 Other Health Professional Us
Primary
Secondary
Concomitant
Vomiting Hospitalization 69 Male 12/13/2012 Other Health Professional Us
Primary
Secondary
Concomitant
Skin Ulcer Other Serious 12/5/2010 67 Female 9/14/2012 Other Health Professional Us
Primary
Concomitant
Interacting
Sick Sinus Syndrome Life Threatening 9/11/2011 77 Male 10/24/2012 Consumer Au
Primary
Secondary
Pneumonia Other Serious 1/9/2012 76 Male 8/28/2012 Other Health Professional Us
Primary
Concomitant
Peripheral Ischaemia Hospitalization 3/25/2012 71 Male 9/18/2012 Physician Us
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/2012 65 Male 8/30/2012 Consumer Us
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/9/2012 55 Male 10/2/2012 Physician Us
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 7/2/2012 66 Male 10/5/2012 Physician Us
Primary
Secondary
Concomitant
Syncope Hospitalization 6/5/2012 67 Male 8/30/2012 Physician Country Not Specified
Primary
Secondary
Concomitant
Pancreatitis Hospitalization 7/7/2012 60 Male 9/4/2012 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 7/20/2012 63 Female 9/17/2012 Physician Us
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 5/15/2012 63 Female 10/2/2012 Consumer Us
Primary
Secondary
Concomitant
Hypersensitivity Other Serious 6/26/2012 54 Male 11/2/2012 Consumer Us
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/9/2012 55 Male 9/28/2012 Consumer Us
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 6/9/2012 55 Male 10/10/2012 Other Health Professional Us
Primary
Secondary
Concomitant
Rotator Cuff Syndrome Hospitalization 8/21/2012 65 Male 10/16/2012 Consumer Hk
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 9/7/2012 72 Male 10/12/2012 Other Health Professional Country Not Specified
Primary
Secondary
Concomitant
Hypovolaemia Hospitalization 8/2/2012 80 Male 10/31/2012 Consumer Us
Primary
Secondary
Concomitant
Sudden Cardiac Death Death 60 Male 10/26/2012 Other Health Professional Se
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 7/25/2012 80 Female 11/9/2012 Physician Us
Primary
Secondary
Concomitant

Drug Data