Aleve (Caplet) combined with Aspirin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Hepatic Failure Death 1/1/2004 66 Male 220 lb 1/9/2006 United States
Primary
Secondary
Inflammation Other Serious 1/9/2006 56 Male 230 lb 1/23/2006 United States
Primary
Secondary
Concomitant
Weight Decreased 10/1/2005 53 Female 194 lb 1/20/2006 Consumer United States
Primary
Secondary
Concomitant
Haematochezia Other Serious 8/1/2005 77 Male 180 lb 3/2/2006 United States
Primary
Concomitant
Rectal Haemorrhage Other Serious Female 139 lb 3/2/2006 United States
Primary
Secondary
Concomitant
Rash Pruritic Other Serious 1/5/2005 77 Female 195 lb 3/2/2006 Other Health Professional United States
Primary
Concomitant
Swollen Tongue Hospitalization 3/30/2005 62 Female 120 lb 3/2/2006 United States
Primary
Secondary
Concomitant
Vasculitis Other Serious 5/22/2005 53 Female 230 lb 3/2/2006 United States
Primary
Concomitant
Haemorrhage Other Serious 3/1/2005 79 Male 175 lb 3/2/2006 United States
Primary
Secondary
Concomitant
Drug Ineffective Death 1/24/2000 73 Female 196 lb 5/8/2006 Physician United States
Primary
Concomitant
Overdose Other Serious 1/1/2002 67 Female 216 lb 5/9/2006 Lawyer United States
Primary
Concomitant
Myocardial Infarction Hospitalization 9/1/2002 49 Male 190 lb 5/9/2006 Lawyer United States
Primary
Concomitant
Visual Field Defect Hospitalization 5/11/2003 73 Female 161 lb 5/9/2006 Physician United States
Primary
Concomitant
Sleep Apnoea Syndrome Disability 8/1/2001 54 Male 196 lb 5/15/2006 Lawyer United States
Primary
Concomitant
Overdose Hospitalization 10/17/2000 51 Male 185 lb 5/15/2006 Lawyer United States
Primary
Concomitant
Vascular Pseudoaneurysm Hospitalization 6/16/2004 56 Male 218 lb 5/15/2006 Physician United States
Primary
Concomitant
Synovial Cyst Hospitalization 10/30/2000 53 Male 280 lb 5/16/2006 Physician United States
Primary
Concomitant
Hypertension Hospitalization 1/1/2001 61 Male 335 lb 5/18/2006 Physician United States
Primary
Secondary
Concomitant
Insomnia 12/1/2005 87 Male 130 lb 4/3/2006 United States
Primary
Concomitant
Dysgeusia 82 Female 127 lb 4/3/2006 Consumer United States
Primary
Concomitant
Chest Pain Other Serious 5/17/2006 65 Female 5/25/2006 United States
Primary
Concomitant
Cholelithiasis Hospitalization 5/28/2006 Female 159 lb 6/9/2006 Physician United States
Primary
Secondary
Concomitant
Drug Exposure During Pregnancy Congenital Anomaly 6/6/2006 Male 6/20/2006 Other Health Professional United States
Primary
Concomitant
Palpitations 2/20/2006 59 Female 182 lb 4/17/2006 Consumer United States
Primary
Concomitant
Oedema Peripheral Other Serious Female 190 lb 7/10/2006 United States
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 6/1/2006 79 Male 190 lb 7/10/2006 United States
Primary
Concomitant
Respiratory Arrest Life Threatening 6/1/2006 67 Male 166 lb 7/11/2006 United States
Primary
Concomitant
Joint Swelling Other Serious Female 190 lb 7/11/2006 United States
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 6/1/2006 79 Male 190 lb 7/12/2006 Consumer United States
Primary
Concomitant
Pneumonitis Hospitalization 7/3/2006 62 Female 7/21/2006 Physician United States
Primary
Secondary
Concomitant
Weight Increased 11/1/2005 66 Male 7/21/2006 Consumer United States
Primary
Secondary
Concomitant
Wheezing Other Serious 7/1/2006 62 Female 8/1/2006 Physician United States
Primary
Secondary
Concomitant
Vulvovaginitis Trichomonal Other Serious 1/1/2006 65 Female 165 lb 7/20/2006 Physician United States
Primary
Secondary
Concomitant
Shock Other Serious 55 Female 8/7/2006 United States
Primary
Concomitant
Blood Pressure Increased Other Serious 5/21/2006 59 Male 170 lb 8/10/2006 Physician United States
Primary
Secondary
Concomitant
Gastric Cancer Life Threatening 7/1/2006 Female 125 lb 8/18/2006 Physician United States
Primary
Concomitant
Hypoaesthesia Other Serious 6/27/2006 26 Male 161 lb 8/21/2006 Consumer United States
Primary
Concomitant
Wound Dehiscence Other Serious 1/1/2002 87 Male 170 lb 8/24/2006 Physician United States
Primary
Secondary
Concomitant
Coagulation Time Prolonged Other Serious Female 161 lb 8/29/2006 Consumer United States
Primary
Secondary
Concomitant
Tachycardia Hospitalization 5/20/2006 90 Female 132 lb 6/12/2006 Pharmacist United States
Primary
Secondary
Concomitant
Carcinoid Tumour Of The Stomach Life Threatening 7/1/2006 Female 125 lb 9/6/2006 Physician United States
Primary
Concomitant
Tooth Disorder Other Serious Female 220 lb 9/11/2006 Consumer United States
Primary
Secondary
Concomitant
Vaginal Haemorrhage Other Serious 6/1/2006 74 Female 157 lb 9/12/2006 Consumer United States
Primary
Secondary
Concomitant
Haemorrhage Other Serious Female 161 lb 9/13/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Transplant Other Serious 9/1/2004 56 Female 161 lb 9/14/2006 Consumer United States
Primary
Secondary
Concomitant
Haemorrhage Other Serious Female 161 lb 9/15/2006 Consumer United States
Primary
Secondary
Concomitant
Ulcer Haemorrhage Other Serious 1/1/2004 74 Female 181 lb 9/19/2006 Consumer United States
Primary
Secondary
Concomitant
Ulcer Haemorrhage Other Serious 1/1/2004 74 Female 181 lb 9/22/2006 Consumer United States
Primary
Secondary
Concomitant
Haemorrhage Other Serious 3/1/2005 79 Male 175 lb 2/28/2007 United States
Primary
Secondary
Concomitant
Urticaria Generalised Hospitalization 5/29/2006 84 Female 142 lb 2/28/2007 United States
Primary
Concomitant
Ulcer Haemorrhage Hospitalization 3/21/2006 67 Male 225 lb 2/28/2007 United States
Primary
Concomitant
Blood Urine Present Other Serious 2/6/2006 63 Male 200 lb 2/28/2007 United States
Primary
Secondary
Concomitant
Restlessness Other Serious 1/21/2006 62 Male 178 lb 2/28/2007 United States
Primary
Concomitant
Blood Pressure Increased Other Serious 4/1/2006 79 Female 180 lb 2/28/2007 United States
Primary
Concomitant
Ulcer Haemorrhage Other Serious 7/27/2006 76 Male 275 lb 2/28/2007 United States
Primary
Secondary
Concomitant
Blood Urine Present Other Serious 10/12/2006 79 Male 197 lb 2/28/2007 United States
Primary
Concomitant
Haematochezia Other Serious 8/28/2006 78 Female 162 lb 2/28/2007 United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 8/9/2006 67 Female 170 lb 2/28/2007 United States
Primary
Concomitant
Alopecia 1/1/2007 72 Female 110 lb 3/9/2008 Consumer United States
Primary
Secondary
Concomitant
Urticaria 7/7/2007 51 Female 190 lb 7/7/2007 Consumer United States
Primary
Concomitant
No Adverse Event 8/3/2007 72 Female 198 lb 8/5/2007 Consumer United States
Primary
Concomitant
Haematemesis Hospitalization 9/1/2007 95 Female 110 lb 3/31/2008 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 9/11/2007 95 Female 110 lb 4/10/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Retinal Haemorrhage Other Serious 1/1/2008 60 Female 4/3/2008 United States
Primary
Concomitant
Confusional State Other Serious 52 Male 181 lb 4/15/2008 Consumer United States
Primary
Secondary
Rash Other Serious 1/1/2006 61 Female 154 lb 4/29/2008 Consumer United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 4/12/2008 68 Female 111 lb 4/22/2008 United States
Primary
Concomitant
Urticaria Other Serious 9/1/1996 22 Female 130 lb 5/8/2008 Consumer United States
Primary
Secondary
Concomitant
Rectal Haemorrhage Other Serious 4/28/2008 75 Female 181 lb 5/12/2008 Consumer United States
Primary
Secondary
Concomitant
Menorrhagia Other Serious 58 Female 399 lb 5/14/2008 Consumer United States
Primary
Secondary
Concomitant
Renal Transplant Other Serious 55 Female 181 lb 5/29/2008 Consumer United States
Primary
Secondary
Concomitant
Sciatica 87 Female 141 lb 5/29/2008 Consumer United States
Primary
Concomitant
Malabsorption 11/21/2007 57 Male 209 lb 6/2/2008 Consumer United States
Primary
Secondary
Concomitant
Oesophagitis Other Serious 5/22/2008 83 Male 192 lb 6/5/2008 Consumer United States
Primary
Secondary
Concomitant
Lacrimation Increased 1/1/2008 73 Male 249 lb 6/9/2008 Consumer United States
Primary
Secondary
Concomitant
Plasmacytoma Death 4/21/2008 62 Female 6/3/2008 Physician United States
Primary
Concomitant
Contusion 3/1/2008 64 Female 154 lb 6/15/2008 Consumer United States
Primary
Secondary
Concomitant
Flushing 3/26/2008 71 Male 165 lb 6/15/2008 Consumer United States
Primary
Secondary
Concomitant
Arthralgia 3/24/2008 71 Female 6/15/2008 Consumer United States
Primary
Concomitant
Migraine 8/28/2007 61 Male 185 lb 6/16/2008 Consumer United States
Primary
Secondary
Concomitant
Rectal Haemorrhage Other Serious 4/28/2008 75 Female 181 lb 6/16/2008 Consumer United States
Primary
Secondary
Concomitant
Blood Glucose Increased 68 Male 231 lb 6/19/2008 Consumer United States
Primary
Concomitant
Gastric Haemorrhage Other Serious Female 6/25/2008 Consumer United States
Primary
Secondary
Dyspepsia Other Serious 1/1/2007 85 Male 181 lb 7/1/2008 Consumer United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2005 58 Female 211 lb 7/3/2008 United States
Primary
Concomitant
Dyspepsia Other Serious 1/1/2007 85 Male 181 lb 7/11/2008 Consumer United States
Primary
Secondary
Concomitant
Dyspepsia Other Serious 1/1/2007 85 Male 181 lb 7/14/2008 Consumer United States
Primary
Secondary
Concomitant
Haemorrhage Urinary Tract Other Serious 7/7/2008 73 Male 247 lb 7/21/2008 Consumer United States
Primary
Secondary
Concomitant
Atrioventricular Block Other Serious 10/19/2007 78 Female 169 lb 5/29/2008 Other Health Professional United States
Primary
Concomitant
Throat Irritation 10/4/2007 59 Male 201 lb 7/22/2008 Consumer United States
Primary
Secondary
Concomitant
Stomach Discomfort 6/10/2008 69 Male 194 lb 7/22/2008 Consumer United States
Primary
Secondary
Concomitant
Urticaria 68 Female 150 lb 7/23/2008 Consumer United States
Primary
Concomitant
Alopecia 1/1/2007 72 Female 110 lb 7/23/2008 Consumer United States
Primary
Secondary
Concomitant
Insomnia 87 Female 161 lb 7/24/2008 Consumer United States
Primary
Concomitant
Myalgia 54 Female 119 lb 7/24/2008 Consumer United States
Primary
Concomitant
Urticaria Other Serious 7/4/2008 59 Male 209 lb 7/25/2008 Consumer United States
Primary
Secondary
Concomitant
Thirst 1/1/2008 84 Female 143 lb 7/28/2008 Consumer United States
Primary
Secondary
Concomitant
Blood Testosterone Increased 10/1/2007 60 Female 141 lb 7/28/2008 Consumer United States
Primary
Secondary
Concomitant
Nausea 1/12/2008 41 Male 165 lb 7/29/2008 Consumer United States
Primary
Secondary
Night Sweats 1/1/2007 78 Female 148 lb 7/29/2008 Consumer United States
Primary
Concomitant
Wound Complication Other Serious 8/1/2007 52 Female 145 lb 7/28/2008 Physician United States
Primary
Concomitant
Dyspepsia Other Serious 1/1/2007 84 Male 181 lb 8/4/2008 Consumer United States
Primary
Secondary
Concomitant
Plasmacytoma Death 4/21/2008 62 Female 7/23/2008 Physician United States
Primary
Concomitant
Dizziness 6/17/2008 69 Male 205 lb 8/14/2008 Consumer United States
Primary
Secondary
Concomitant
Musculoskeletal Pain 6/21/2008 78 Male 170 lb 8/18/2008 Consumer United States
Primary
Concomitant
Oesophagitis Other Serious 6/1/2008 78 Female 148 lb 8/22/2008 Consumer United States
Primary
Secondary
Concomitant
Gastric Haemorrhage Other Serious Female 8/25/2008 Consumer United States
Primary
Secondary
Blood Potassium Increased Other Serious 8/1/2008 66 Male 223 lb 8/26/2008 Consumer United States
Primary
Secondary
Concomitant
Blood Potassium Increased Other Serious 8/11/2008 66 Male 223 lb 9/5/2008 Consumer United States
Primary
Secondary
Concomitant
Contusion 60 Male 249 lb 9/8/2008 Consumer United States
Primary
Secondary
Concomitant
Oesophagitis Other Serious 6/1/2008 78 Female 148 lb 9/10/2008 Consumer United States
Primary
Secondary
Concomitant
Urticaria 68 Female 150 lb 9/15/2008 Consumer United States
Primary
Concomitant
Oesophagitis Other Serious 6/1/2008 78 Female 143 lb 9/23/2008 Consumer United States
Primary
Secondary
Concomitant
Blood Glucose Increased 68 Male 231 lb 9/23/2008 Consumer United States
Primary
Concomitant
Flushing 3/26/2008 71 Male 165 lb 9/23/2008 Consumer United States
Primary
Secondary
Concomitant
Nasal Dryness 4/29/2008 73 Female 194 lb 9/24/2008 Consumer United States
Primary
Concomitant
Fatigue 6/2/2008 89 Female 146 lb 10/9/2008 Consumer United States
Primary
Concomitant
Nausea 8/15/2008 68 Male 157 lb 10/9/2008 Consumer United States
Primary
Concomitant
Haemorrhage Urinary Tract Other Serious 7/7/2008 73 Male 247 lb 10/20/2008 Consumer United States
Primary
Secondary
Concomitant
Dyspepsia Other Serious 1/1/2007 84 Male 181 lb 10/27/2008 Physician United States
Primary
Secondary
Concomitant
Renal Transplant Other Serious 55 Female 181 lb 10/29/2008 Consumer United States
Primary
Secondary
Concomitant
Oesophagitis Other Serious 6/1/2008 78 Female 143 lb 10/30/2008 Consumer United States
Primary
Secondary
Concomitant
Chest Pain 76 Female 146 lb 11/4/2008 Consumer United States
Primary
Concomitant
Rash Other Serious 1/1/2006 61 Female 154 lb 11/7/2008 Consumer United States
Primary
Concomitant
Blood Potassium Increased Other Serious 8/11/2008 66 Male 223 lb 11/7/2008 Consumer United States
Primary
Secondary
Concomitant
Haematochezia Other Serious 9/1/2008 77 Female 130 lb 11/11/2008 Consumer United States
Primary
Concomitant
Saliva Altered 77 Male 249 lb 11/25/2008 Consumer United States
Primary
Secondary
Concomitant
Urticaria Other Serious 7/4/2008 59 Male 209 lb 12/1/2008 Consumer Canada
Primary
Secondary
Concomitant
Blood Pressure Increased Other Serious 11/24/2008 82 Female 141 lb 12/2/2008 Consumer United States
Primary
Concomitant
Contusion 1/1/2008 85 Female 106 lb 12/2/2008 Consumer United States
Primary
Secondary
Concomitant
Oedema Peripheral 9/30/2008 61 Female 12/2/2008 Consumer United States
Primary
Concomitant
Thirst 1/1/2008 84 Female 143 lb 12/4/2008 Consumer United States
Primary
Secondary
Concomitant
Skin Warm 4/2/2008 77 Female 132 lb 12/4/2008 Consumer United States
Primary
Concomitant
Malabsorption 11/21/2007 57 Male 209 lb 12/4/2008 Consumer United States
Primary
Secondary
Concomitant
Blood Pressure Increased 70 Male 181 lb 12/8/2008 Consumer United States
Primary
Concomitant
Arthralgia 71 Female 110 lb 12/8/2008 Consumer United States
Primary
Concomitant
Pain In Extremity Hospitalization 9/18/2008 50 Female 11/26/2008 United States
Primary
Concomitant
Pruritus 11/5/2008 84 Female 137 lb 12/9/2008 Consumer United States
Primary
Concomitant
Chromaturia 91 Male 150 lb 12/9/2008 Consumer United States
Primary
Concomitant
Blood Cholesterol Increased 2/1/2008 79 Female 170 lb 12/10/2008 Consumer United States
Primary
Secondary
Concomitant
Contusion 3/1/2008 64 Female 154 lb 12/10/2008 Consumer United States
Primary
Concomitant
Interacting
No Adverse Event 10/6/2008 48 Female 249 lb 12/16/2008 Consumer United States
Primary
Concomitant
Constipation 4/20/2008 69 Female 170 lb 12/22/2008 Consumer United States
Primary
Concomitant
Restlessness 5/28/2008 72 Male 201 lb 12/22/2008 Consumer United States
Primary
Secondary
Concomitant
Arthralgia Female 181 lb 12/29/2008 Consumer United States
Primary
Secondary
Concomitant
Blood Pressure Increased Other Serious 11/24/2008 82 Female 141 lb 12/30/2008 Consumer United States
Primary
Concomitant
Faeces Discoloured 4/16/2008 74 Male 205 lb 12/30/2008 Consumer United States
Primary
Secondary
Concomitant
Faeces Discoloured 4/16/2008 74 Male 205 lb 12/31/2008 Consumer United States
Primary
Secondary
Concomitant
Dyspepsia 2/1/2008 69 Female 265 lb 1/5/2009 Consumer United States
Primary
Secondary
Concomitant
Chromaturia 11/1/2008 92 Male 150 lb 1/5/2009 Consumer United States
Primary
Concomitant

Drug Data