Blinded *Placebo combined with Naproxen

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Encephalopathy Hospitalization 7/7/2008 Female 286 lb 12/22/2008 Physician United States
Primary
Secondary
Concomitant
Hypotension Hospitalization 8/10/2008 Male 223 lb 12/23/2008 Physician United States
Primary
Secondary
Concomitant
Osteoarthritis Hospitalization 9/25/2008 12/24/2008 Physician Brazil
Primary
Secondary
Concomitant
Intervertebral Disc Protrusion Hospitalization 3/6/2008 12/24/2008 Physician Brazil
Primary
Secondary
Concomitant
Subarachnoid Haemorrhage Other Serious 10/27/2008 Female 110 lb 12/29/2008 Physician United States
Primary
Secondary
Concomitant
Obesity Other Serious 8/3/1962 Male 350 lb 12/29/2008 Physician United States
Primary
Secondary
Concomitant
Lower Gastrointestinal Haemorrhage Hospitalization 9/19/2008 Female 146 lb 12/24/2008 Physician United States
Primary
Secondary
Concomitant
Shoulder Arthroplasty Hospitalization Female 279 lb 12/30/2008 Physician
Primary
Secondary
Osteoarthritis Hospitalization 9/25/2008 12/31/2008 Physician Brazil
Primary
Secondary
Concomitant
Death Death 12/20/2008 Male 184 lb 12/31/2008 Physician United States
Primary
Secondary
Concomitant
Encephalopathy Hospitalization 7/7/2008 Female 286 lb 1/5/2009 Physician United States
Primary
Secondary
Concomitant
Intervertebral Disc Protrusion Hospitalization 3/6/2008 Female 1/6/2009 Physician Brazil
Primary
Secondary
Concomitant
Lower Gastrointestinal Haemorrhage Other Serious 9/19/2008 Female 146 lb 1/8/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Malaise Life Threatening 9/15/2008 Female 1/12/2009 Physician United States
Primary
Secondary
Concomitant
Arthralgia Hospitalization 4/14/2008 Male 228 lb 1/13/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Follicle Centre Lymphoma, Follicular Grade I, Ii, Iii Other Serious 6/2/2008 Female 150 lb 1/13/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cervical Spinal Stenosis Other Serious 8/1/2007 Male 144 lb 1/15/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonia Other Serious 2/1/2008 1/15/2009 Physician Canada
Primary
Secondary
Concomitant
Pneumonia Other Serious 1/1/2009 1/22/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Lumbar Radiculopathy Hospitalization 11/12/2008 Male 198 lb 1/23/2009 Physician United States
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Other Serious 8/25/2008 2/11/2009 Physician Colombia
Primary
Secondary
Concomitant
Lower Respiratory Tract Infection Other Serious 8/25/2008 2/18/2009 Physician Colombia
Primary
Secondary
Concomitant
Cardiac Disorder Death 12/20/2008 Male 184 lb 2/20/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Knee Arthroplasty Hospitalization 7/16/2008 Male 262 lb 2/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 1/1/2009 2/27/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/13/2008 Female 203 lb 3/12/2009 Physician United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 12/26/2008 Female 182 lb 3/12/2009 Physician United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 2/6/2009 Male 210 lb 3/13/2009 Physician United States
Primary
Secondary
Concomitant
General Physical Health Deterioration Hospitalization 3/3/2009 3/16/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Ulcer Hospitalization 3/1/2009 Female 265 lb 3/16/2009 Physician United States
Primary
Secondary
Concomitant
Haemorrhagic Anaemia Other Serious 10/9/2007 Female 275 lb 3/18/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Device Failure Hospitalization 3/9/2009 Female 304 lb 3/25/2009 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 2/13/2009 Female 176 lb 3/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Knee Arthroplasty Hospitalization 2/3/2009 Female 243 lb 3/25/2009 Physician United States
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 2/11/2009 Female 173 lb 3/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Road Traffic Accident Hospitalization 5/10/2008 Female 176 lb 3/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Lumbar Spinal Stenosis Hospitalization 2/20/2009 Female 189 lb 3/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Osteoarthritis Hospitalization 10/16/2008 Male 160 lb 3/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 2/6/2009 Male 209 lb 3/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/13/2008 Female 203 lb 3/25/2009 Physician United States
Primary
Secondary
Concomitant
Metastases To Meninges Hospitalization 3/3/2009 3/30/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Other Serious 3/13/2009 Female 180 lb 3/27/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Life Threatening 9/15/2008 Female 194 lb 3/30/2009 Physician United States
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 3/23/2009 Female 117 lb 3/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Ulcer Hospitalization 3/1/2009 Female 235 lb 3/30/2009 Physician United States
Primary
Secondary
Concomitant
Erythema Nodosum Hospitalization 9/29/2008 Female 199 lb 3/31/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 1/1/2009 4/2/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Coronary Revascularisation Other Serious 12/26/2008 Female 182 lb 4/3/2009 Physician United States
Primary
Secondary
Concomitant
Lumbar Spinal Stenosis Hospitalization 9/24/2008 Female 190 lb 4/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cholecystitis Acute Hospitalization 4/13/2009 Physician Canada
Primary
Secondary
Concomitant
Acute Coronary Syndrome Other Serious 12/26/2008 Female 182 lb 4/17/2009 Physician United States
Primary
Secondary
Concomitant
Aortic Aneurysm Repair Hospitalization 1/1/2005 Male 220 lb 4/20/2009 Physician United States
Primary
Secondary
Concomitant
Aortic Stenosis Hospitalization 5/11/2008 Male 270 lb 4/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Angina Pectoris Hospitalization 9/24/2008 Female 210 lb 4/17/2009 Physician United States
Primary
Secondary
Concomitant
Paraesthesia Other Serious 2/22/2009 Female 467 lb 4/20/2009 United States
Primary
Secondary
Concomitant
Haematoma Other Serious 2/16/2009 Male 239 lb 4/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Knee Arthroplasty Hospitalization 7/16/2008 Male 262 lb 4/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Gastritis Haemorrhagic Hospitalization 12/12/2007 Female 322 lb 4/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Wound Necrosis Other Serious 11/12/2008 4/27/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Acute Coronary Syndrome Other Serious 12/26/2008 Female 182 lb 4/28/2009 Physician United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Hospitalization 3/1/2009 Female 235 lb 5/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Stress Urinary Incontinence Hospitalization Female 188 lb 5/8/2009 Physician United States
Primary
Secondary
Concomitant
No Adverse Event 1/28/2009 Male 212 lb 5/8/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Coronary Syndrome Other Serious 12/26/2008 Female 182 lb 5/12/2009 Physician United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Hospitalization 5/12/2009 57 5/20/2009 Brazil
Primary
Secondary
Concomitant
Atrial Flutter Hospitalization 5/5/2009 57 5/22/2009 Brazil
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/21/2009 58 5/22/2009 Physician Costa Rica
Primary
Secondary
Concomitant
Enterocele Other Serious 7/14/2008 Female 136 lb 5/26/2009 Physician United States
Primary
Secondary
Concomitant
Nerve Compression Hospitalization Male 238 lb 5/26/2009 Physician United States
Primary
Secondary
Concomitant
Localised Intraabdominal Fluid Collection Hospitalization 4/19/2009 Female 244 lb 5/26/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Obesity Hospitalization 3/10/2009 Female 229 lb 5/27/2009 United States
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 1/2/2009 Male 261 lb 5/27/2009 United States
Primary
Secondary
Concomitant
Osteoarthritis Hospitalization 1/1/2004 Female 160 lb 5/27/2009 Other Health Professional United States
Primary
Secondary
Iron Deficiency Anaemia Other Serious 3/12/2009 Female 180 lb 5/28/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pulmonary Hypertension Hospitalization 5/12/2009 57 6/2/2009 Brazil
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Hospitalization 4/7/2009 Male 218 lb 6/3/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Atrial Flutter Hospitalization 5/5/2009 57 6/4/2009 Physician Brazil
Primary
Secondary
Concomitant
Osteoarthritis Hospitalization 2/3/2009 Female 243 lb 6/4/2009 Physician United States
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 4/9/2009 Male 319 lb 6/7/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oesophageal Spasm Hospitalization 2/27/2009 Female 245 lb 6/5/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Device Failure Hospitalization 3/9/2009 Female 304 lb 6/8/2009 Physician United States
Primary
Secondary
Concomitant
Osteoarthritis Hospitalization 1/1/2004 Female 160 lb 6/15/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Localised Intraabdominal Fluid Collection Hospitalization 4/19/2009 Female 244 lb 6/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 5/4/2009 Male 262 lb 6/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Anaemia Hospitalization 4/7/2009 Male 218 lb 6/18/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Neck Pain Hospitalization 6/12/2009 61 6/19/2009 Physician Philippines
Primary
Secondary
Concomitant
Hypertensive Crisis Hospitalization 6/12/2009 61 6/26/2009 Physician Philippines
Primary
Secondary
Concomitant
Iron Deficiency Anaemia Other Serious 3/12/2009 Female 181 lb 6/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Pneumonitis Hospitalization 3/23/2009 Female 117 lb 6/29/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Arthritis Hospitalization 6/22/2009 44 7/2/2009 Physician Ukraine
Primary
Secondary
Renal Failure Acute Hospitalization 5/31/2009 Male 260 lb 7/6/2009 United States
Primary
Secondary
Concomitant
Haematoma Other Serious 2/16/2009 Male 239 lb 7/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Right Atrial Dilatation Hospitalization 5/4/2009 Male 262 lb 7/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Arthritis Hospitalization 6/22/2009 44 7/10/2009 Physician Ukraine
Primary
Secondary
Cholecystitis Acute Hospitalization 2/18/2009 74 7/10/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 5/31/2009 Male 260 lb 7/13/2009 Physician United States
Primary
Secondary
Concomitant
Syncope Hospitalization 8/25/2008 Male 190 lb 7/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 6/12/2008 73 7/28/2009 Physician Peru
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/21/2009 57 7/30/2009 Physician Costa Rica
Primary
Secondary
Concomitant
Myocardial Ischaemia Hospitalization 8/10/2008 Male 223 lb 7/27/2009 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/21/2009 57 8/3/2009 Physician Costa Rica
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 2/27/2009 Female 245 lb 8/6/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Heart Rate Irregular Hospitalization 1/13/2007 Female 165 lb 8/10/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oesophageal Spasm Hospitalization 7/24/2009 63 8/12/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Pulmonary Hypertension Hospitalization 5/12/2009 57 8/14/2009 Brazil
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 8/14/2009 Physician Philippines
Primary
Secondary
Concomitant
Syncope Hospitalization 8/25/2008 Male 190 lb 8/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Oesophageal Spasm Hospitalization 7/24/2009 63 8/17/2009 Other Health Professional Canada
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 5/8/2007 Female 212 lb 8/21/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 8/28/2009 Physician Philippines
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 8/25/2008 Male 190 lb 8/28/2009 United States
Primary
Secondary
Concomitant
Vision Blurred Hospitalization 2/27/2009 Female 245 lb 9/10/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Dyspnoea Other Serious 6/9/2009 Female 180 lb 9/15/2009 Physician United States
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 10/13/2008 Female 203 lb 9/18/2009 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Other Serious 6/9/2009 Female 180 lb 9/21/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 9/25/2009 Physician Philippines
Primary
Secondary
Concomitant
Thrombophlebitis Other Serious 3/10/2009 Male 190 lb 12/29/2009 Physician United States
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Hospitalization 1/5/2010 Male 323 lb 1/14/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Oxygen Saturation Decreased Hospitalization 1/5/2010 Male 323 lb 2/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiomyopathy Hospitalization 1/26/2010 Female 167 lb 2/5/2010 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Exertional Other Serious 1/8/2010 Female 172 lb 2/9/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Lung Infection Hospitalization 1/5/2010 Male 322 lb 2/12/2010 Physician United States
Primary
Secondary
Concomitant
Coronary Artery Stenosis Hospitalization 1/8/2010 Female 172 lb 2/19/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Suicide Attempt Life Threatening 1/13/2010 Female 133 lb 2/22/2010 Physician United States
Primary
Secondary
Concomitant
Upper Gastrointestinal Haemorrhage Other Serious 4/1/2008 64 Female 121 lb 2/24/2010 Physician Philippines
Primary
Secondary
Concomitant
Suicide Attempt Life Threatening 1/13/2010 Female 133 lb 3/2/2010 Physician United States
Primary
Secondary
Concomitant
Coronary Artery Stenosis Other Serious 1/8/2010 Female 172 lb 3/2/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/21/2009 57 Female 126 lb 3/3/2010 Physician Costa Rica
Primary
Secondary
Concomitant
Myocardial Infarction Life Threatening 6/12/2008 73 Female 163 lb 3/3/2010 Physician Peru
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Other Serious 11/8/2008 69 Female 383 lb 3/5/2010 Other Health Professional Canada
Primary
Concomitant
Interacting
Suicide Attempt Life Threatening 1/13/2010 Female 133 lb 3/17/2010 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Other Serious 3/21/2009 57 Female 126 lb 3/16/2010 Physician Costa Rica
Primary
Secondary
Concomitant
Unintended Pregnancy Other Serious Female 116 lb 3/17/2010 Physician United States
Primary
Secondary
Drug Interaction Hospitalization 11/8/2008 69 Female 383 lb 3/18/2010 Other Health Professional Canada
Primary
Concomitant
Interacting
Thrombophlebitis Other Serious 3/10/2009 Male 190 lb 3/19/2010 Physician United States
Primary
Secondary
Concomitant
Unintended Pregnancy Other Serious 1/14/2010 Female 117 lb 3/23/2010 Physician United States
Primary
Secondary
Peripheral Ischaemia Other Serious 12/4/2009 76 Male 157 lb 3/24/2010 Physician Philippines
Primary
Secondary
Concomitant
Suicide Attempt Life Threatening 1/13/2010 Female 133 lb 3/25/2010 Physician United States
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 1/1/2009 57 Male 127 lb 4/1/2010 Other Health Professional Canada
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 3/21/2010 66 Male 207 lb 4/2/2010 Physician Ukraine
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 6/12/2008 73 Female 163 lb 4/6/2010 Physician Peru
Primary
Secondary
Concomitant
Mitral Valve Calcification Hospitalization 1/13/2007 77 Female 165 lb 4/8/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Gastrointestinal Haemorrhage Hospitalization 9/24/2009 81 Female 146 lb 4/19/2010 Physician United States
Primary
Secondary
Concomitant
Suicide Attempt Life Threatening 1/13/2010 55 Female 133 lb 4/26/2010 Physician United States
Primary
Secondary
Concomitant
Atrial Fibrillation Hospitalization 3/21/2010 66 Male 207 lb 4/29/2010 Physician Ukraine
Primary
Secondary
Concomitant
Colitis Hospitalization 4/23/2010 83 Female 164 lb 4/30/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vasculitis Other Serious 10/8/2009 65 Female 199 lb 5/7/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vasculitis Other Serious 10/8/2009 65 Female 198 lb 5/17/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Colitis Hospitalization 4/23/2010 83 Female 164 lb 5/21/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Nephrotic Syndrome Other Serious 7/22/2008 48 Female 137 lb 5/21/2010 Physician Mexico
Primary
Secondary
Concomitant

Drug Data