Aleve (Caplet) combined with Simvastatin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Chromaturia Other Serious 1/7/2008 58 Female 205 lb 5/5/2008 Consumer United States
Primary
Secondary
Concomitant
Sciatica 87 Female 141 lb 5/29/2008 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 3/1/2008 70 Female 165 lb 6/11/2008 Consumer United States
Primary
Secondary
Concomitant
Chromaturia Other Serious 1/7/2008 58 Female 205 lb 6/23/2008 Physician United States
Primary
Secondary
Concomitant
Chromaturia Other Serious 1/7/2008 58 Female 205 lb 6/24/2008 Physician United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 3/1/2008 69 Female 165 lb 6/11/2008 United States
Primary
Secondary
Concomitant
No Adverse Event 2/26/2008 69 Female 168 lb 7/23/2008 Consumer United States
Primary
Concomitant
Thirst 1/1/2008 84 Female 143 lb 7/28/2008 Consumer United States
Primary
Secondary
Concomitant
Rash 6/1/2008 71 Male 249 lb 8/13/2008 Consumer United States
Primary
Concomitant
Pain In Extremity 76 Male 174 lb 8/18/2008 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 3/1/2008 70 Female 165 lb 8/21/2008 Consumer United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 3/1/2008 70 Female 165 lb 10/20/2008 Consumer United States
Primary
Secondary
Concomitant
Arthralgia 9/30/2008 82 Female 181 lb 10/30/2008 Consumer United States
Primary
Concomitant
Erythema 6/10/2008 85 Female 134 lb 10/31/2008 Consumer United States
Primary
Concomitant
Oropharyngeal Discomfort Other Serious 11/1/2008 71 Male 280 lb 11/21/2008 Consumer United States
Primary
Concomitant
Thirst 1/1/2008 84 Female 143 lb 12/4/2008 Consumer United States
Primary
Secondary
Concomitant
Pruritus 11/5/2008 84 Female 137 lb 12/9/2008 Consumer United States
Primary
Concomitant
Skin Haemorrhage 6/1/2008 65 Female 148 lb 1/5/2009 Consumer United States
Primary
Concomitant
Constipation 80 Female 194 lb 1/12/2009 Consumer United States
Primary
Secondary
Concomitant
Abdominal Discomfort 12/15/2008 83 Female 130 lb 1/15/2009 Consumer United States
Primary
Concomitant
Back Pain 9/3/2008 79 Male 165 lb 1/15/2009 Consumer United States
Primary
Concomitant
Insomnia 69 Female 141 lb 1/15/2009 Consumer United States
Primary
Concomitant
Haemoglobin Decreased Hospitalization 8/19/2008 51 Male 1/26/2009 Pharmacist United States
Primary
Concomitant
Oropharyngeal Discomfort Other Serious 11/1/2008 71 Male 280 lb 2/3/2009 Consumer United States
Primary
Concomitant
Arthralgia 1/15/2009 75 Male 150 lb 2/16/2009 Consumer United States
Primary
Concomitant
Constipation 1/4/2009 59 Female 130 lb 2/16/2009 Consumer United States
Primary
Concomitant
Joint Swelling Other Serious 3/11/2009 59 Male 229 lb 5/13/2009 Consumer United States
Primary
Concomitant
Insomnia 4/22/2009 66 Female 161 lb 5/26/2009 Consumer United States
Primary
Concomitant
Pruritus 8/1/2008 47 Male 223 lb 6/3/2009 Consumer United States
Primary
Concomitant
Arthralgia 1/15/2009 75 Male 150 lb 7/10/2009 Consumer United States
Primary
Concomitant
Arthralgia 6/20/2009 69 Male 185 lb 7/31/2009 Consumer United States
Primary
Concomitant
Blood Pressure Decreased Other Serious 8/2/2009 66 Male 247 lb 8/6/2009 Consumer United States
Primary
Secondary
Concomitant
Blood Pressure Decreased Other Serious 8/2/2009 66 Male 247 lb 8/10/2009 Consumer United States
Primary
Secondary
Concomitant
Blood Glucose Increased 7/29/2009 69 Male 220 lb 8/28/2009 Consumer United States
Primary
Concomitant
Constipation 8/1/2009 73 Male 194 lb 9/18/2009 Consumer United States
Primary
Concomitant
Blood Pressure Increased 7/1/2009 69 Male 205 lb 10/2/2009 Consumer United States
Primary
Concomitant
Hypoaesthesia Facial 9/2/2009 78 Female 183 lb 10/7/2009 Consumer United States
Primary
Concomitant
Pain In Extremity 9/1/2009 65 Female 115 lb 10/12/2009 Consumer United States
Primary
Concomitant
Swelling Face 10/8/2009 52 Male 209 lb 11/6/2009 Consumer United States
Primary
Concomitant
Blood Pressure Increased 10/18/2009 64 Male 150 lb 11/23/2009 Consumer United States
Primary
Concomitant
Arthritis 11/6/2009 79 Male 220 lb 12/17/2009 Consumer United States
Primary
Concomitant
Drug Ineffective 11/30/2009 79 Female 190 lb 12/31/2009 Consumer United States
Primary
Concomitant
Muscle Spasms 11/27/2009 64 Male 154 lb 12/31/2009 Consumer United States
Primary
Concomitant
Muscular Weakness 12/17/2009 69 Male 220 lb 1/8/2010 Consumer United States
Primary
Concomitant
Somnolence 11/1/2009 67 Male 225 lb 1/14/2010 Consumer United States
Primary
Concomitant
Arthralgia 12/16/2009 67 Male 260 lb 1/14/2010 Consumer United States
Primary
Concomitant
Death Death Male 171 lb 1/19/2010 Consumer United States
Primary
Concomitant
Muscular Weakness Other Serious 12/17/2009 69 Male 220 lb 1/25/2010 Consumer United States
Primary
Concomitant
Haemorrhage Other Serious 1/17/2010 61 Female 227 lb 1/29/2010 Consumer United States
Primary
Concomitant
Pruritus Generalised 52 Female 117 lb 2/4/2010 Consumer United States
Primary
Concomitant
Back Pain Female 150 lb 2/5/2010 Consumer United States
Primary
Concomitant
Weight Increased 1/1/1994 50 Male 2/5/2010 Consumer United States
Primary
Concomitant
Arthralgia 1/4/2010 74 Male 220 lb 2/18/2010 Consumer United States
Primary
Concomitant
Arthritis 1/1/2008 71 Female 148 lb 2/22/2010 Consumer United States
Primary
Concomitant
Lower Gastrointestinal Haemorrhage Other Serious 1/17/2010 61 Female 227 lb 2/24/2010 Consumer Canada
Primary
Concomitant
Headache 2/2/2010 58 Female 209 lb 3/5/2010 Consumer United States
Primary
Concomitant
Wheezing Other Serious Female 154 lb 3/9/2010 Other Health Professional United States
Primary
Concomitant
Urinary Incontinence Hospitalization 1/11/2010 71 Male 3/11/2010 United States
Primary
Concomitant
Back Pain 12/1/2009 51 Male 174 lb 4/5/2010 Consumer United States
Primary
Concomitant
Pruritus 3/10/2010 74 Male 249 lb 4/12/2010 Consumer United States
Primary
Concomitant
Palpitations 1/1/2010 55 Female 134 lb 4/15/2010 Consumer United States
Primary
Concomitant
Arthralgia 1/1/2010 74 Male 223 lb 4/19/2010 Consumer United States
Primary
Concomitant
Rash Female 154 lb 4/19/2010 Other Health Professional United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/2009 72 Male 194 lb 4/22/2010 Physician United States
Primary
Concomitant
Visual Impairment 11/1/2009 58 Female 161 lb 5/4/2010 Consumer United States
Primary
Concomitant
Bone Pain 1/1/2010 81 Male 150 lb 5/10/2010 Consumer United States
Primary
Concomitant
Somnolence 4/16/2010 58 Male 165 lb 5/20/2010 Consumer United States
Primary
Concomitant
Renal Pain 3/1/2009 70 Female 121 lb 6/14/2010 Consumer United States
Primary
Concomitant
Swelling Other Serious 6/28/2010 78 Female 134 lb 7/7/2010 Consumer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/2009 72 Male 194 lb 7/12/2010 Physician United States
Primary
Concomitant
Pulmonary Mass Hospitalization 6/7/2010 58 Male 167 lb 7/12/2010 Consumer United States
Primary
Concomitant
Myocardial Infarction Other Serious 5/15/2007 69 Female 120 lb 7/14/2010 Consumer United States
Primary
Concomitant
Weight Increased Other Serious 1/1/2009 78 Male 108 lb 7/14/2010 Consumer United States
Primary
Concomitant
Headache 6/16/2010 67 Female 170 lb 7/19/2010 Consumer United States
Primary
Concomitant
No Adverse Event 7/4/2010 77 Female 161 lb 7/21/2010 Consumer United States
Primary
Concomitant
Cholelithiasis Hospitalization 7/9/2010 71 Male 236 lb 7/21/2010 Physician United States
Primary
Concomitant
Pulmonary Mass Hospitalization 6/7/2010 58 Male 167 lb 7/21/2010 Other Health Professional
Primary
Concomitant
Wrong Technique In Drug Usage Process 3/1/2008 68 Male 120 lb 7/21/2010 Consumer United States
Primary
Concomitant
Contusion 5/1/2010 72 Male 201 lb 7/29/2010 Consumer United States
Primary
Concomitant
Urticaria Other Serious 1/1/2005 62 Female 220 lb 7/29/2010 Consumer United States
Primary
Concomitant
Cholelithiasis Hospitalization 7/9/2010 71 Male 236 lb 7/30/2010 Physician United States
Primary
Concomitant
Rash Macular 7/7/2010 85 Male 194 lb 8/3/2010 Consumer United States
Primary
Concomitant
Abdominal Discomfort 5/1/2010 79 Female 139 lb 8/9/2010 Consumer United States
Primary
Concomitant
Urticaria Other Serious 1/1/2005 62 Female 220 lb 8/9/2010 Other Health Professional United States
Primary
Concomitant
Arthritis 68 Female 249 lb 8/10/2010 Consumer United States
Primary
Concomitant
Vomiting Disability 1/1/2010 62 Male 190 lb 8/11/2010 Consumer United States
Primary
Concomitant
Palpitations Hospitalization 5/1/2010 47 Female 190 lb 6/2/2010 Consumer United States
Primary
Concomitant
Ulcer Haemorrhage Hospitalization 1/1/2009 67 Male 229 lb 8/25/2010 Consumer United States
Primary
Concomitant
Respiratory Disorder Hospitalization 6/2/2010 51 Female 264 lb 8/25/2010 Physician United States
Primary
Concomitant
Flatulence 7/1/2010 Male 185 lb 8/26/2010 Consumer United States
Primary
Concomitant
Epistaxis 7/1/2010 74 Male 229 lb 8/27/2010 Consumer United States
Primary
Concomitant
Urticaria Other Serious 1/1/2005 62 Female 220 lb 8/27/2010 Other Health Professional United States
Primary
Concomitant
Paraesthesia Male 275 lb 8/28/2010 United States
Primary
Concomitant
Pruritus 54 Male 210 lb 8/28/2010 United States
Primary
Concomitant
Paraesthesia 1/15/2010 80 Male 210 lb 8/28/2010 United States
Primary
Concomitant
Myalgia Male 260 lb 8/28/2010 United States
Primary
Concomitant
Paraesthesia 5/1/2010 68 Male 246 lb 8/29/2010 Consumer United States
Primary
Concomitant
Palpitations 5/3/2010 73 Male 180 lb 8/29/2010 Consumer United States
Primary
Concomitant
Vomiting Disability 1/1/2010 62 Male 190 lb 9/2/2010 Consumer United States
Primary
Concomitant
No Adverse Event 8/8/2010 64 Male 220 lb 9/8/2010 Consumer United States
Primary
Concomitant
Nephropathy Other Serious 1/1/2008 62 Female 223 lb 9/9/2010 Consumer United States
Primary
Concomitant
Nausea 68 Female 205 lb 9/16/2010 Consumer United States
Primary
Secondary
Concomitant
Rash Macular 7/7/2010 85 Male 190 lb 9/17/2010 Consumer United States
Primary
Concomitant
Haemoptysis Hospitalization 5/17/2009 80 Male 9/23/2010 Physician United States
Primary
Concomitant
Hot Flush 8/18/2010 85 Male 229 lb 9/27/2010 Consumer United States
Primary
Concomitant
Nephropathy Other Serious 1/1/2008 62 Female 223 lb 9/28/2010 Consumer United States
Primary
Concomitant
Myalgia Other Serious 9/4/2010 64 Female 145 lb 9/29/2010 Consumer United States
Primary
Concomitant
Pollakiuria 8/24/2010 65 Male 287 lb 10/18/2010 Consumer United States
Primary
Concomitant
Rotator Cuff Syndrome Hospitalization 7/28/2010 66 Male 186 lb 10/14/2010 Physician United States
Primary
Concomitant
Dyspnoea Death 10/7/2010 52 Female 214 lb 10/12/2010 Other Health Professional United States
Primary
Concomitant
Vision Blurred Other Serious 1/1/2010 56 Male 265 lb 10/26/2010 Physician United States
Primary
Concomitant
Throat Irritation 76 Male 10/13/2010 Consumer United States
Primary
Concomitant
Death Death Female 187 lb 11/2/2010 Consumer United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/2009 72 Male 194 lb 11/5/2010 United States
Primary
Concomitant
Urinary Tract Infection Other Serious 1/1/2009 72 Male 194 lb 11/23/2010 United States
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 7/1/2010 72 Female 196 lb 12/1/2010 Consumer United States
Primary
Concomitant
Hiccups 10/1/2010 12/3/2010 Consumer United States
Primary
Concomitant
Flatulence 11/10/2010 82 Female 146 lb 12/10/2010 Consumer United States
Primary
Concomitant
Haemoptysis Other Serious 1/1/2010 80 Male 419 lb 1/28/2011 Consumer United States
Primary
Concomitant
Drug Ineffective Female 2/8/2011 Consumer United States
Primary
Concomitant
Back Pain 12/1/2010 38 Female 229 lb 2/15/2011 Consumer United States
Primary
Concomitant
No Adverse Event 11/7/2010 70 Female 175 lb 2/18/2011 Consumer United States
Primary
Concomitant
Blood Pressure Increased 12/19/2010 76 Male 190 lb 3/15/2011 Consumer United States
Primary
Secondary
Concomitant
No Adverse Event 1/11/2011 64 Male 214 lb 3/18/2011 Consumer United States
Primary
Concomitant
Arthralgia 2/1/2011 62 Male 210 lb 3/21/2011 Consumer United States
Primary
Concomitant
Drug Administration Error Male 161 lb 3/22/2011 Consumer United States
Primary
Concomitant
No Adverse Event 2/22/2011 79 Female 130 lb 3/23/2011 Consumer United States
Primary
Concomitant
No Adverse Event 1/18/2011 71 Male 310 lb 3/29/2011 Consumer United States
Primary
Concomitant
Drug Ineffective 2/23/2011 76 Male 152 lb 3/29/2011 Consumer United States
Primary
Concomitant
No Adverse Event 10/1/2010 63 Male 269 lb 3/31/2011 Consumer United States
Primary
Concomitant
No Adverse Event 3/31/2011 64 Male 180 lb 4/6/2011 Consumer United States
Primary
Concomitant
Heart Rate Increased 3/10/2011 75 Male 170 lb 4/14/2011 Consumer United States
Primary
Concomitant
No Adverse Event Female 104 lb 4/15/2011 Consumer United States
Primary
Concomitant
No Adverse Event Male 161 lb 4/27/2011 Consumer United States
Primary
Concomitant
No Adverse Event 1/1/2010 64 Male 201 lb 4/29/2011 Consumer United States
Primary
Concomitant
No Adverse Event 4/1/2010 79 Female 134 lb 5/4/2011 Consumer United States
Primary
Concomitant
No Adverse Event Male 190 lb 5/16/2011 Consumer United States
Primary
Concomitant
No Adverse Event 70 Male 214 lb 5/13/2011 Consumer United States
Primary
Concomitant
Rash Papular Female 185 lb 5/11/2011 Consumer United States
Primary
Concomitant
No Adverse Event 1/1/2011 80 Male 161 lb 5/16/2011 Consumer United States
Primary
Concomitant
Back Pain 4/22/2011 65 Male 200 lb 5/20/2011 Consumer United States
Primary
Concomitant
Anhedonia Other Serious 3/7/2007 46 Female 160 lb 6/1/2011 Consumer United States
Primary
Concomitant
No Adverse Event Male 150 lb 5/17/2011 Consumer United States
Primary
Concomitant
Constipation 1/18/2011 49 Female 232 lb 5/30/2011 Consumer United States
Primary
Secondary
Concomitant
Blister Other Serious 40 Male 165 lb 7/12/2011 Consumer United States
Primary
Concomitant
Musculoskeletal Pain 5/31/2011 67 Male 205 lb 7/14/2011 Consumer United States
Primary
Concomitant
Blood Pressure Increased 1/1/2010 85 Female 125 lb 7/16/2011 Consumer United States
Primary
Concomitant
Asthenia 88 Male 155 lb 6/30/2011 Consumer United States
Primary
Concomitant
Drug Effect Decreased 5/1/2011 87 Female 106 lb 7/19/2011 Consumer United States
Primary
Concomitant
No Adverse Event 84 Female 220 lb 8/4/2011 Consumer United States
Primary
Concomitant

Drug Data