Placebo combined with Simvastatin

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
Oral Soft Tissue Disorder Other Serious 3/11/2005 Male 194 lb 3/17/2006 India
Primary
Secondary
Concomitant
Schizophrenia Life Threatening 8/3/2005 Male 222 lb 3/31/2006 Physician United States
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 8/15/2005 Male 215 lb 4/24/2006 United Kingdom
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
Schizophrenia Life Threatening 8/3/2005 Male 222 lb 7/31/2006 Physician United States
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 79 Male 196 lb 5/9/2005 Pharmacist United States
Primary
Secondary
Concomitant
Gastritis Hospitalization 2/25/2006 Female 154 lb 8/21/2006 Physician Denmark
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 8/15/2005 Male 215 lb 9/11/2006 United Kingdom
Primary
Secondary
Concomitant
Ventricular Fibrillation Life Threatening 9/14/2006 Male 176 lb 10/31/2006 Physician Belgium
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 8/15/2005 Male 215 lb 11/28/2006 United Kingdom
Primary
Secondary
Concomitant
Syncope Hospitalization 6/16/2004 82 Male 3/7/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Presyncope Other Serious 6/19/2007 Male 175 lb 6/27/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebrovascular Disorder Life Threatening 1/28/2005 Female 141 lb 8/13/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pericardial Haemorrhage Other Serious 5/4/2004 Female 146 lb 8/15/2007 Physician Denmark
Primary
Secondary
Concomitant
Neutropenic Colitis Death 8/15/2007 65 Male 9/14/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Oesophagitis Hospitalization 10/24/2005 74 Male 157 lb 9/14/2007 Physician Canada
Primary
Secondary
Concomitant
Neutropenic Colitis Death 8/15/2007 65 Male 194 lb 9/26/2007 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 8/15/2007 65 Male 194 lb 10/16/2007 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 11/19/2007 Female 183 lb 11/30/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 10/31/2007 Female 183 lb 12/12/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 1/1/2005 62 Male 126 lb 2/11/2008 Physician United States
Primary
Concomitant
Ventricular Tachycardia Hospitalization 5/25/2006 79 Female 154 lb 2/13/2008 Physician Brazil
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 5/25/2006 79 Female 154 lb 2/13/2008 Physician Brazil
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 8/28/2005 62 Male 126 lb 2/28/2008 Physician United States
Primary
Concomitant
Septic Shock Hospitalization 8/15/2007 65 Male 194 lb 4/25/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Septic Shock Other Serious 8/15/2007 65 Male 194 lb 5/6/2008 Other Health Professional United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 8/15/2007 65 Male 194 lb 5/14/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Sudden Death Death 2/17/2008 79 Male 6/16/2008 Other Health Professional Israel
Primary
Secondary
Concomitant
Septic Shock Other Serious 8/15/2007 65 Male 194 lb 7/3/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/15/2008 67 Male 161 lb 7/29/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 5/25/2006 Female 154 lb 8/14/2008 Physician Brazil
Primary
Secondary
Concomitant
Syncope Hospitalization 5/10/2008 Female 9/2/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Syncope Hospitalization 5/10/2008 Female 9/2/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombosis In Device Other Serious 7/16/2006 60 Female 12/15/2008 Consumer Spain
Primary
Secondary
Concomitant
Anaemia Other Serious 9/9/2008 Male 209 lb 12/31/2008 Physician Canada
Primary
Concomitant
Anaemia Other Serious 9/9/2008 Male 209 lb 1/14/2009 Physician Canada
Primary
Concomitant
Atrial Fibrillation Hospitalization 12/2/2008 Male 192 lb 1/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Anaemia Other Serious 9/9/2008 Male 209 lb 1/22/2009 Physician Canada
Primary
Concomitant
Atrial Fibrillation Hospitalization 12/2/2008 Male 192 lb 3/13/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Aortic Aneurysm Hospitalization 1/21/2009 Male 3/19/2009 Physician Belgium
Primary
Secondary
Tongue Neoplasm Malignant Stage Unspecified Other Serious 4/21/2009 Female 189 lb 6/19/2009 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 6/28/2008 Female 130 lb 6/29/2009 Other Health Professional Portugal
Primary
Secondary
Concomitant
Hypotension Hospitalization 6/7/2009 62 Male 7/6/2009 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 5/25/2006 Female 154 lb 7/7/2009 Physician Brazil
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 12/2/2008 Male 192 lb 7/13/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 5/25/2006 Female 154 lb 7/15/2009 Physician Brazil
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 5/25/2006 Female 154 lb 7/30/2009 Physician Brazil
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 6/9/2009 Female 189 lb 8/10/2009 Physician United States
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/17/2009 Male 172 lb 8/28/2009 Physician United States
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/16/2009 Male 172 lb 9/3/2009 Physician United States
Primary
Secondary
Concomitant
Cellulitis Hospitalization 8/1/2009 71 Male 9/2/2009 Physician United States
Primary
Secondary
Concomitant
Diverticulitis Hospitalization 8/7/2009 Female 168 lb 9/11/2009 Physician Finland
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/16/2009 Male 172 lb 9/14/2009 Physician United States
Primary
Secondary
Concomitant
Vision Blurred Life Threatening 6/4/2009 62 Male 9/15/2009 Physician United States
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 9/29/2009 Physician United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 1/27/2007 Female 154 lb 10/7/2009 Physician Brazil
Primary
Secondary
Concomitant
Tongue Neoplasm Malignant Stage Unspecified Other Serious 7/9/2009 Female 189 lb 10/26/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/27/2009 72 Female 228 lb 10/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 11/20/2009 Physician Finland
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 8/16/2009 Male 172 lb 11/23/2009 Physician United States
Primary
Secondary
Concomitant
Pancreatitis Acute Hospitalization 8/28/2005 62 Male 126 lb 11/30/2009 Physician United States
Primary
Concomitant
Atrial Fibrillation Hospitalization 12/2/2008 75 Male 192 lb 12/7/2009 Physician United States
Primary
Secondary
Concomitant
Wound Dehiscence Hospitalization 10/15/2009 Female 168 lb 12/9/2009 Physician Finland
Primary
Secondary
Concomitant
Haematoma Hospitalization 11/24/2009 Male 12/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Sinus Tachycardia Hospitalization 12/6/2008 59 Female 1/28/2010 Other Health Professional 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
Lung Neoplasm Other Serious 11/25/2009 Male 196 lb 2/2/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/11/2010 79 Female 2/9/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Drug Withdrawal Syndrome Hospitalization 1/19/2010 Male 2/10/2010 Physician
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 1/27/2007 Female 154 lb 2/12/2010 Physician Brazil
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 11/1/2009 Male 196 lb 2/12/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Drug Withdrawal Syndrome Hospitalization 1/19/2010 Male 2/18/2010 Physician
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 Male 2/22/2010 Physician
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 1/11/2010 Female 2/16/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Other Serious 2/10/2009 Female 3/2/2010 Physician
Primary
Secondary
Concomitant
Somnolence Other Serious 11/25/2009 82 Male 187 lb 2/19/2010 Physician United States
Primary
Secondary
Concomitant
Lung Neoplasm Other Serious 11/1/2009 Male 196 lb 3/3/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 4/6/2010 Physician
Primary
Secondary
Concomitant
Pancytopenia Other Serious 11/25/2009 82 Male 187 lb 4/8/2010 Physician United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 3/13/2010 65 Male 4/28/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Tibia Fracture Hospitalization 9/2/2009 76 Female 141 lb 4/29/2010 Physician Panama
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 3/13/2010 65 Male 5/5/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Somnolence Other Serious 11/25/2009 82 Male 187 lb 5/5/2010 Physician United States
Primary
Secondary
Concomitant
Lung Squamous Cell Carcinoma Stage I Other Serious 1/18/2010 60 Male 196 lb 5/11/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Somnolence Other Serious 11/25/2009 82 Male 187 lb 5/13/2010 Physician United States
Primary
Secondary
Concomitant
Somnolence Other Serious 11/25/2009 82 Male 187 lb 5/18/2010 Physician United States
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 5/24/2010 Physician
Primary
Secondary
Concomitant
Somnolence Other Serious 11/25/2009 82 Male 187 lb 5/25/2010 Physician United States
Primary
Secondary
Concomitant
Cardiac Failure Congestive Hospitalization 5/5/2010 78 Female 159 lb 6/15/2010 Physician United States
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 5/31/2010 45 Male 216 lb 6/20/2010 Consumer South Africa
Primary
Secondary
Concomitant
Urticaria Other Serious 12/11/2004 74 Male 201 lb 6/24/2010 Canada
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 5/31/2010 45 Male 216 lb 6/24/2010 Consumer South Africa
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 6/30/2010 Physician
Primary
Secondary
Concomitant
Lung Squamous Cell Carcinoma Stage I Other Serious 1/18/2010 60 Male 196 lb 7/22/2010 Physician France
Primary
Secondary
Concomitant
Electrocardiogram Qt Prolonged Other Serious 1/19/2010 65 Male 7/23/2010 Physician
Primary
Secondary
Concomitant
Renal Impairment Other Serious 5/31/2010 45 Male 216 lb 7/23/2010 Consumer South Africa
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Hospitalization 12/15/2009 75 Male 7/26/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Calculus Bladder Other Serious 4/13/2010 69 Male 212 lb 7/30/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Appendicitis Perforated Hospitalization 6/2/2010 49 Male 271 lb 8/5/2010 Physician United States
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 8/12/2010 80 Male 8/16/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Viral Infection Hospitalization 8/8/2010 Female 8/20/2010 Physician Israel
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 8/12/2010 80 Male 8/23/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Basal Cell Carcinoma 4/1/2010 68 Female 159 lb 8/26/2010 Physician New Zealand
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Other Serious 12/20/2007 66 Female 163 lb 9/2/2010 Physician New Zealand
Primary
Secondary
Concomitant
Nausea Other Serious 11/24/2004 71 Female 9/22/2010 Physician United Kingdom
Primary
Secondary
Concomitant
Pneumonia Hospitalization 7/23/2010 65 Female 173 lb 9/24/2010 Physician Poland
Primary
Secondary
Concomitant
Migraine Hospitalization 69 Male 164 lb 10/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 4/8/2009 63 Male 11/1/2010
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 11/29/2008 69 Male 11/5/2010 Physician Germany
Primary
Secondary
Concomitant
Pneumonia Life Threatening 9/28/2010 78 Male 194 lb 11/10/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Herpes Zoster Hospitalization 11/29/2008 69 Male 11/16/2010 Physician Germany
Primary
Secondary
Concomitant
Acute Myocardial Infarction Other Serious 9/1/2010 50 Male 309 lb 11/17/2010 Physician Sweden
Primary
Secondary
Concomitant
Myocardial Ischaemia Hospitalization 9/20/2010 61 Male 194 lb 11/18/2010 Physician Germany
Primary
Secondary
Concomitant
Urinary Tract Obstruction Other Serious 4/13/2010 69 Male 212 lb 11/21/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Sinus Tachycardia Other Serious 9/20/2010 70 Male 222 lb 11/30/2010 Physician United States
Primary
Secondary
Concomitant
Respiratory Arrest Other Serious 9/26/2010 66 Male 188 lb 12/10/2010 Physician Brazil
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Life Threatening 8/12/2010 80 Male 12/13/2010 Consumer United Kingdom
Primary
Secondary
Concomitant
Urticaria Hospitalization 7/15/2010 61 Male 12/1/2010 China
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 4/24/2009 64 Male 203 lb 12/22/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Respiratory Tract Infection Life Threatening 12/7/2010 51 Female 179 lb 12/31/2010 Physician Brazil
Primary
Secondary
Concomitant
Concomitant Disease Progression Hospitalization 12/1/2010 38 Male 170 lb 1/19/2011 Physician France
Primary
Secondary
Concomitant
Supraventricular Tachycardia Other Serious 12/23/2010 71 Female 1/20/2011 Physician New Zealand
Primary
Secondary
Concomitant
Convulsion Other Serious 2/21/2010 58 Male 187 lb 1/21/2011 Other Health Professional Spain
Primary
Secondary
Concomitant
Tendon Rupture Hospitalization 10/6/2010 55 Female 187 lb 1/26/2011 Other Health Professional New Zealand
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Hospitalization 12/21/2010 61 Male 1/27/2011 Consumer Germany
Primary
Secondary
Concomitant
Myocardial Ischaemia Other Serious 2/11/2009 67 Male 2/16/2011 Physician Israel
Primary
Secondary
Concomitant
Traumatic Brain Injury Hospitalization 3/5/2010 73 Male 208 lb 2/25/2011 Physician United States
Primary
Secondary
Concomitant
Myocardial Ischaemia Death 2/11/2009 67 Male 2/28/2011 Consumer Israel
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Death 1/18/2010 60 Male 196 lb 2/28/2011 Physician France
Primary
Secondary
Concomitant
Aortic Aneurysm Rupture Hospitalization 8/12/2010 80 Male 3/1/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 3/5/2009 71 Male 428 lb 3/3/2011 Consumer United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Other Serious 1/18/2010 60 Male 196 lb 3/7/2011 Physician France
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 2/11/2009 67 Male 3/15/2011 Consumer Israel
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 2/11/2009 67 Male 3/22/2011 Consumer Israel
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 3/5/2010 73 Male 208 lb 3/31/2011 Physician United States
Primary
Secondary
Concomitant
Skull Fractured Base Hospitalization 3/5/2010 73 Male 208 lb 4/28/2011 Physician United States
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 2/11/2009 67 Male 197 lb 5/11/2011 Consumer Israel
Primary
Secondary
Concomitant
Pleura Carcinoma Hospitalization 12/20/2010 81 Male 5/2/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Basal Cell Carcinoma Other Serious 9/23/2010 71 Male 176 lb 5/13/2011 Other Health Professional Sweden
Primary
Concomitant
Cerebrovascular Accident Hospitalization 4/2/2011 74 Male 220 lb 5/25/2011 Physician Denmark
Primary
Secondary
Concomitant
Wheezing Hospitalization 6/21/2006 82 Male 174 lb 5/25/2011 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
Ventricular Tachycardia Hospitalization 5/9/2011 63 Male 6/6/2011 Physician United States
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 5/1/2011 6/6/2011 Physician Sweden
Primary
Concomitant
Gastric Ulcer Hospitalization 10/18/2009 56 Female 6/6/2011 Other Health Professional Norway
Primary
Secondary
Concomitant

Drug Data