Aleve (Caplet) combined with Hydrochlorothiazide

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Blood Pressure Increased Other Serious 10/5/2005 63 Female 270 lb 1/13/2006 United States
Primary
Concomitant
Treatment Noncompliance Hospitalization 11/1/2005 76 Male 180 lb 2/6/2006 United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 11/1/2005 76 Male 175 lb 2/14/2006 United States
Primary
Concomitant
Histamine Level Increased Other Serious 12/7/2004 64 Male 165 lb 3/2/2006 Physician United States
Primary
Concomitant
Irritable Bowel Syndrome Other Serious 1/1/2005 55 Male 136 lb 3/2/2006 United States
Primary
Concomitant
Oedema Peripheral Other Serious 4/1/2006 75 Female 210 lb 5/8/2006 Consumer United States
Primary
Secondary
Concomitant
Swollen Tongue Hospitalization 3/13/2006 54 Male 5/10/2006 United States
Primary
Secondary
Concomitant
Overdose Hospitalization 10/17/2000 51 Male 185 lb 5/15/2006 Lawyer United States
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 10/1/2005 81 Male 153 lb 5/26/2006 Physician United States
Primary
Concomitant
Osteonecrosis Other Serious 9/1/2005 82 Female 7/11/2006 Physician United States
Primary
Concomitant
Shock Haemorrhagic Hospitalization 1/1/2006 76 Female 7/31/2006 Physician United States
Primary
Concomitant
Transfusion Other Serious 1/1/2006 71 Male 181 lb 8/1/2006 Consumer United States
Primary
Concomitant
Transfusion Other Serious 1/1/2006 71 Male 181 lb 8/2/2006 Consumer United States
Primary
Concomitant
Soft Tissue Infection Other Serious 1/4/2005 82 Female 8/4/2006 Physician United States
Primary
Concomitant
Renal Tubular Necrosis Required Intervention 8/7/2006 72 Male 194 lb 8/30/2006 Pharmacist United States
Primary
Concomitant
Urticaria Generalised Hospitalization 5/29/2006 84 Female 142 lb 2/28/2007 United States
Primary
Concomitant
Stomach Discomfort Female 190 lb 4/19/2007 Consumer United States
Primary
Concomitant
No Adverse Event 8/3/2007 72 Female 198 lb 8/5/2007 Consumer United States
Primary
Concomitant
Blood Glucose Increased Other Serious 11/15/2007 63 Male 209 lb 4/28/2008 Consumer United States
Primary
Concomitant
Constipation 83 Female 123 lb 6/15/2008 Consumer United States
Primary
Concomitant
No Adverse Event 3/9/2008 57 Female 245 lb 6/16/2008 Consumer United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 4/25/2008 82 Female 198 lb 6/25/2008 Physician
Primary
Secondary
Concomitant
Atrioventricular Block Other Serious 10/19/2007 78 Female 169 lb 5/29/2008 Other Health Professional United States
Primary
Concomitant
Headache 1/1/2008 73 Female 172 lb 7/28/2008 Consumer United States
Primary
Concomitant
Blood Pressure Increased 11/1/2007 77 Female 130 lb 7/28/2008 Consumer United States
Primary
Concomitant
Constipation 10/1/2007 78 Female 141 lb 7/29/2008 Consumer United States
Primary
Concomitant
Nasal Dryness 4/29/2008 73 Female 194 lb 9/24/2008 Consumer United States
Primary
Concomitant
Chest Pain 76 Female 146 lb 11/4/2008 Consumer United States
Primary
Concomitant
Micturition Frequency Decreased 77 Female 172 lb 1/7/2009 Consumer United States
Primary
Concomitant
Contusion 11/22/2008 73 Female 126 lb 1/15/2009 Consumer United States
Primary
Concomitant
Constipation 1/4/2009 59 Female 130 lb 2/16/2009 Consumer United States
Primary
Concomitant
Micturition Frequency Decreased 77 Female 172 lb 2/23/2009 Consumer United States
Primary
Concomitant
Back Pain 12/18/2008 80 Female 157 lb 2/26/2009 Consumer United States
Primary
Concomitant
Chest Pain 76 Female 146 lb 3/5/2009 Consumer United States
Primary
Concomitant
Nasal Dryness 4/29/2008 73 Female 194 lb 3/6/2009 Consumer United States
Primary
Concomitant
Aphthous Stomatitis 1/30/2009 75 Male 194 lb 4/8/2009 Consumer United States
Primary
Concomitant
Heart Rate Increased 5/6/2009 58 Female 249 lb 6/4/2009 Consumer United States
Primary
Concomitant
Abdominal Pain Upper 5/13/2009 73 Female 146 lb 6/10/2009 Consumer United States
Primary
Concomitant
Dizziness 6/1/2009 72 Female 201 lb 7/15/2009 Consumer United States
Primary
Secondary
Concomitant
Blood Pressure Decreased Other Serious 8/2/2009 66 Male 247 lb 8/6/2009 Consumer United States
Primary
Secondary
Concomitant
Epistaxis Other Serious 7/1/2009 73 Male 126 lb 8/6/2009 Consumer United States
Primary
Concomitant
Blood Pressure Decreased Other Serious 8/2/2009 66 Male 247 lb 8/10/2009 Consumer United States
Primary
Secondary
Concomitant
Diarrhoea 7/26/2009 82 Female 181 lb 8/25/2009 Consumer United States
Primary
Concomitant
Blood Glucose Increased 7/29/2009 69 Male 220 lb 8/28/2009 Consumer United States
Primary
Concomitant
Drug Screen Positive 8/3/2009 58 Male 269 lb 9/1/2009 Consumer United States
Primary
Concomitant
Restlessness 1/1/2009 83 Female 154 lb 9/14/2009 Consumer United States
Primary
Concomitant
Constipation 8/1/2009 73 Male 194 lb 9/18/2009 Consumer United States
Primary
Concomitant
Swelling Face 9/30/2009 68 Female 185 lb 11/2/2009 Consumer United States
Primary
Concomitant
Vertigo Other Serious 1/1/2009 86 Female 141 lb 11/10/2009 Physician United States
Primary
Concomitant
Hyponatraemia Hospitalization 10/15/2009 82 166 lb 11/3/2009 Pharmacist United States
Primary
Secondary
Concomitant
Photosensitivity Reaction 52 Male 360 lb 12/22/2009 Consumer United States
Primary
Concomitant
Muscle Spasms 1/1/2009 82 Female 143 lb 12/23/2009 Consumer United States
Primary
Concomitant
Foreign Body 11/30/2009 68 Male 150 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
Flushing 4/5/2009 Female 190 lb 1/15/2010 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
Pain In Extremity 1/1/2007 74 Male 192 lb 1/25/2010 Consumer United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 70 Female 1/20/2010 United States
Primary
Concomitant
Productive Cough 1/4/2010 87 Male 170 lb 2/4/2010 Consumer United States
Primary
Concomitant
Neck Pain 12/17/2009 45 Male 154 lb 2/8/2010 Other Health Professional United States
Primary
Concomitant
Pruritus 12/9/2009 Female 2/16/2010 United States
Primary
Concomitant
Anaemia Hospitalization 1/29/2010 70 Male 236 lb 2/19/2010 United States
Primary
Secondary
Concomitant
Rash 6/1/2009 53 Female 2/26/2010 Other Health Professional United States
Primary
Concomitant
Thirst Other Serious 1/1/2009 Male 192 lb 3/25/2010 Physician United States
Primary
Secondary
Concomitant
Dehydration Hospitalization 8/16/2009 69 Male 177 lb 3/30/2010 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 3/19/2010 60 Male 267 lb 4/1/2010 Physician United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 1/1/2009 56 Male 192 lb 4/5/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Pain In Extremity 1/1/2007 74 Male 192 lb 4/8/2010 Consumer United States
Primary
Concomitant
Tendonitis Other Serious 4/30/2009 63 Female 216 lb 4/13/2010 Physician Japan
Primary
Concomitant
Staphylococcal Infection Hospitalization 3/21/2010 60 Male 267 lb 4/16/2010 Physician United States
Primary
Secondary
Concomitant
Hearing Impaired Other Serious Female 4/19/2010 United States
Primary
Concomitant
Pneumonia Hospitalization 4/5/2010 62 Female 4/20/2010 United States
Primary
Concomitant
Bone Pain 1/1/2010 81 Male 150 lb 5/10/2010 Consumer United States
Primary
Concomitant
Sciatica Other Serious 1/1/2010 82 Female 150 lb 5/11/2010 Consumer Brazil
Primary
Concomitant
Weight Decreased Other Serious 3/29/2010 69 Female 214 lb 5/11/2010 United States
Primary
Concomitant
Dizziness 4/1/2010 73 Female 165 lb 5/20/2010 Consumer United States
Primary
Concomitant
Hearing Impaired Other Serious Female 5/25/2010 Physician United States
Primary
Concomitant
Limb Discomfort Other Serious 2/1/2008 38 Female 249 lb 6/3/2010 Physician United States
Primary
Secondary
Concomitant
Throat Irritation 11/17/2009 68 Male 229 lb 6/3/2010 Other Health Professional United States
Primary
Concomitant
Weight Decreased Other Serious 2/1/2010 77 Female 6/16/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 86 Female 146 lb 6/29/2010 Consumer United States
Primary
Concomitant
Pruritus 5/31/2010 65 Male 229 lb 7/1/2010 Consumer United States
Primary
Concomitant
Rash Macular 1/1/2010 72 Female 185 lb 7/1/2010 Consumer United States
Primary
Concomitant
Pollakiuria 1/1/2007 59 Female 160 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
Renal Failure Chronic Hospitalization 5/1/2006 74 Female 7/12/2010 Lawyer United States
Primary
Concomitant
Nausea 9/5/2007 60 Female 207 lb 7/16/2010 Consumer United States
Primary
Concomitant
Headache 6/16/2010 67 Female 170 lb 7/19/2010 Consumer United States
Primary
Concomitant
Myalgia Other Serious 1/1/2010 75 Female 122 lb 7/22/2010 Other Health Professional United States
Primary
Concomitant
Myalgia Other Serious 1/1/2010 75 Female 122 lb 8/13/2010 Other Health Professional United States
Primary
Concomitant
Headache 52 Female 121 lb 8/16/2010 Consumer United States
Primary
Concomitant
Uterine Leiomyoma Other Serious 7/10/2000 62 Female 143 lb 8/24/2010 Physician United States
Primary
Secondary
Concomitant
Blood Glucose Increased 6/1/2010 76 Male 201 lb 8/27/2010 Consumer 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 Female 195 lb 8/28/2010 United States
Primary
Concomitant
Thrombocytopenia Other Serious Male 8/28/2010 Physician United States
Primary
Concomitant
Flushing Female 229 lb 8/29/2010 Consumer United States
Primary
Concomitant
Arthritis 7/1/2010 57 Female 148 lb 9/2/2010 Consumer United States
Primary
Concomitant
Myalgia Other Serious 1/1/2010 75 Female 122 lb 9/6/2010 Other Health Professional United States
Primary
Concomitant
Tension 8/7/2010 75 Female 159 lb 9/10/2010 Consumer United States
Primary
Concomitant
Arthralgia 8/10/2010 74 Female 126 lb 9/15/2010 Consumer United States
Primary
Concomitant
Ventricular Extrasystoles Hospitalization 65 Female 9/2/2010 United States
Primary
Concomitant
Oedema Peripheral 8/1/2010 54 Female 229 lb 9/23/2010 Consumer United States
Primary
Concomitant
Abdominal Pain Upper 70 Female 201 lb 9/29/2010 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 3/29/2010 69 Female 214 lb 9/29/2010 United States
Primary
Concomitant
Product Quality Issue 48 Female 10/13/2010 Consumer United States
Primary
Concomitant
Dysphonia 84 Male 10/13/2010 Consumer United States
Primary
Concomitant
Squamous Cell Carcinoma Death 9/15/2010 75 Male 11/18/2010 Physician United States
Primary
Concomitant
Visual Impairment 11/18/2010 64 Male 220 lb 11/23/2010 Consumer 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
Intracardiac Thrombus Other Serious 3/1/2008 12/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Intracardiac Thrombus Other Serious 3/1/2008 12/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Intracardiac Thrombus Other Serious 3/1/2008 12/3/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Arthralgia 11/8/2010 Female 170 lb 12/6/2010 Consumer United States
Primary
Concomitant
Drug Ineffective Female 119 lb 3/14/2011 Consumer United States
Primary
Concomitant
Blood Pressure Increased 12/19/2010 76 Male 190 lb 3/15/2011 Consumer United States
Primary
Secondary
Concomitant
Fatigue Female 134 lb 3/17/2011 Consumer United States
Primary
Concomitant
Heart Rate Increased 12/28/2010 Female 126 lb 3/18/2011 Consumer United States
Primary
Concomitant
No Adverse Event 1/11/2011 64 Male 214 lb 3/18/2011 Consumer United States
Primary
Concomitant
No Adverse Event 2/22/2011 79 Female 130 lb 3/23/2011 Consumer United States
Primary
Concomitant
Arthralgia Female 119 lb 3/24/2011 Consumer United States
Primary
Concomitant
No Adverse Event 61 Female 4/4/2011 Consumer United States
Primary
Concomitant
Blood Pressure Increased Female 123 lb 4/7/2011 Consumer United States
Primary
Concomitant
Unevaluable Event Other Serious 2/1/2006 45 Male 141 lb 4/18/2011 Lawyer United States
Primary
Concomitant
Renal Failure Other Serious 2/1/2006 45 Male 141 lb 4/27/2011 Consumer United States
Primary
Concomitant
No Adverse Event 70 Male 214 lb 5/13/2011 Consumer United States
Primary
Concomitant
No Adverse Event 11/12/2010 61 Female 172 lb 5/17/2011 Consumer United States
Primary
Concomitant
Oral Discomfort 4/23/2011 102 Female 139 lb 5/21/2011 Consumer United States
Primary
Concomitant
Cholecystitis Other Serious 10/1/2006 45 Female 165 lb 5/25/2011 Other Health Professional United States
Primary
Concomitant
No Adverse Event 60 Female 220 lb 5/27/2011 Consumer United States
Primary
Concomitant
Emotional Distress Hospitalization 4/2/2005 60 Male 288 lb 5/31/2011 Consumer United States
Primary
Concomitant
Carpal Tunnel Syndrome 3/1/2011 50 Female 5/31/2011 Consumer United States
Primary
Concomitant
Renal Failure Death 1/1/2007 53 Male 275 lb 6/10/2011 Consumer United States
Primary
Concomitant
Cerebrovascular Accident Other Serious 1/1/1996 49 Female 195 lb 6/21/2011 Consumer United States
Primary
Secondary
Concomitant
Haematochezia Other Serious 6/8/2011 51 Male 165 lb 6/28/2011 Consumer United States
Primary
Concomitant
No Adverse Event 1/1/2004 Female 181 lb 7/19/2011 Consumer United States
Primary
Concomitant
No Adverse Event Female 168 lb 7/26/2011 Consumer United States
Primary
Concomitant
Dyspepsia 6/26/2011 64 Female 201 lb 7/18/2011 Consumer United States
Primary
Concomitant
Hypersensitivity 7/12/2011 61 Female 7/16/2011 Consumer United States
Primary
Concomitant
Constipation Male 176 lb 7/25/2011 Consumer United States
Primary
Concomitant
Incorrect Dose Administered 11/12/2010 80 Female 159 lb 9/19/2011 Consumer United States
Primary
Concomitant
Drug Hypersensitivity 9/6/2011 74 Male 216 lb 9/20/2011 Consumer United States
Primary
Concomitant
Drug Ineffective 69 Male 351 lb 9/21/2011 Consumer United States
Primary
Concomitant
Muscle Strain 73 Male 187 lb 9/28/2011 Consumer United States
Primary
Concomitant
Lip Dry 2/14/2010 78 Female 311 lb 2/25/2011 Consumer United States
Primary
Concomitant
Blood Urine Present Other Serious Male 141 lb 3/8/2011 Consumer United States
Primary
Concomitant
Throat Irritation 81 Female 126 lb 11/21/2011 Consumer United States
Primary
Concomitant
Muscle Strain 5/27/2011 73 Male 187 lb 11/22/2011 Consumer United States
Primary
Concomitant

Drug Data