Lovaza combined with Simvastatin

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Subdural Haematoma Other Serious 6/5/2007 78 Male 10/31/2007 Sweden
Primary
Secondary
Concomitant
Subdural Haematoma Other Serious 6/5/2007 78 Male 11/16/2007 Sweden
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 4/28/2008 60 Male 5/5/2008 Pharmacist United States
Primary
Concomitant
Hepatic Enzyme Increased Other Serious Male 5/19/2008 Consumer United States
Primary
Concomitant
Throat Tightness 7/18/2008 Female 8/27/2008 United States
Primary
Concomitant
Blood Glucose Increased 5/26/2008 67 Male 8/15/2008 United States
Primary
Concomitant
Oedema Peripheral Other Serious 9/4/2008 Female 132 lb 9/17/2008 Other Health Professional United States
Primary
Concomitant
Tachycardia 8/2/2008 Female 9/29/2008 Consumer
Primary
Secondary
Concomitant
Tenderness 8/1/2008 Female 163 lb 11/26/2008 United States
Primary
Concomitant
Wheezing Other Serious 1/1/2008 85 Female 12/3/2008 Consumer United Kingdom
Primary
Secondary
Headache 3/1/2008 200 lb 12/4/2008 Consumer United States
Primary
Concomitant
Presyncope Hospitalization 9/25/2008 84 Male 12/22/2008 Consumer United States
Primary
Concomitant
Psychomotor Hyperactivity Other Serious 10/18/2008 12/29/2008 Other Health Professional United Kingdom
Primary
Concomitant
Anaemia Other Serious 9/9/2008 Male 209 lb 12/31/2008 Physician Canada
Primary
Concomitant
Sinusitis 1/1/2008 65 Male 235 lb 12/15/2008 Physician United States
Primary
Concomitant
Rheumatoid Arthritis Other Serious 10/1/2007 Male 172 lb 1/12/2009 Physician United States
Primary
Concomitant
Anaemia Other Serious 9/9/2008 Male 209 lb 1/14/2009 Physician Canada
Primary
Concomitant
Anaemia Other Serious 9/9/2008 Male 209 lb 1/22/2009 Physician Canada
Primary
Concomitant
Oedema Hospitalization 1/1/2007 56 Male 261 lb 1/22/2009 Other Health Professional United States
Primary
Concomitant
Renal Impairment 1/16/2008 69 Female 2/4/2009 Consumer United States
Primary
Concomitant
Product Quality Issue 7/1/2008 54 Male 180 lb 1/13/2009 Pharmacist United States
Primary
Concomitant
Haematoma 12/9/2008 Female 2/17/2009 Consumer
Primary
Concomitant
Psoriasis Hospitalization Male 380 lb 2/20/2009 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 1/1/2008 Male 180 lb 2/23/2009 Physician United States
Primary
Secondary
Concomitant
Wheezing Other Serious 1/1/2008 85 Female 2/24/2009 Consumer United Kingdom
Primary
Secondary
Pleural Effusion Hospitalization 1/7/2008 Male 200 lb 2/24/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Haematoma 12/9/2008 Female 2/24/2009 Consumer
Primary
Concomitant
Liver Function Test Abnormal 12/5/2008 Male 2/24/2009 United States
Primary
Concomitant
Dysgeusia 9/30/2008 68 Male 2/25/2009 Consumer United States
Primary
Concomitant
Lacunar Infarction Other Serious 2/20/2009 Male 205 lb 3/4/2009 Physician United States
Primary
Secondary
Concomitant
Lacunar Infarction Other Serious 2/20/2009 Male 205 lb 3/5/2009 Physician United States
Primary
Secondary
Concomitant
Postnasal Drip 1/13/2009 Female 168 lb 3/14/2009 Other Health Professional United States
Primary
Concomitant
Lacunar Infarction Other Serious 2/20/2009 Male 205 lb 3/18/2009 Physician United States
Primary
Secondary
Concomitant
Dysphonia Other Serious 1/1/2007 Male 3/27/2009 Consumer United States
Primary
Secondary
Concomitant
Sinus Tachycardia Hospitalization 1/7/2009 Male 200 lb 3/31/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Haematoma 12/9/2008 Female 4/16/2009 Consumer
Primary
Concomitant
Sepsis Hospitalization 12/30/2008 67 5/8/2009 Physician Norway
Primary
Secondary
Concomitant
Joint Swelling Other Serious 3/11/2009 59 Male 229 lb 5/13/2009 Consumer United States
Primary
Concomitant
Wheezing Hospitalization 4/8/2009 176 lb 5/15/2009 Physician United States
Primary
Secondary
Concomitant
Withdrawal Syndrome 1/1/2008 5/19/2009 Consumer United States
Primary
Concomitant
Kidney Infection Other Serious 65 Female 176 lb 5/21/2009 Consumer United States
Primary
Concomitant
Myalgia 5/6/2009 Female 202 lb 5/27/2009 United States
Primary
Concomitant
Pleural Effusion Hospitalization 1/7/2009 Male 200 lb 6/10/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Photosensitivity Reaction 4/1/2009 Male 6/15/2009 Physician United States
Primary
Concomitant
Wheezing Hospitalization 4/8/2009 176 lb 6/25/2009 Physician United States
Primary
Secondary
Concomitant
Hemiparesis Hospitalization 8/1/2005 Male 6/30/2009 Consumer United States
Primary
Secondary
Concomitant
Visual Impairment Other Serious 1/15/2009 Female 149 lb 7/13/2009 Other Health Professional United States
Primary
Concomitant
Interacting
Hypertension 6/1/2008 Female 7/23/2009 Consumer United States
Primary
Secondary
Concomitant
Renal Artery Occlusion Other Serious 1/1/2002 Female 8/4/2009 Consumer United States
Primary
Concomitant
Renal Disorder Other Serious Female 146 lb 8/5/2009 Brazil
Primary
Concomitant
Renal Disorder Other Serious Female 146 lb 8/6/2009 Brazil
Primary
Concomitant
Intentional Drug Misuse Other Serious 6/1/2009 64 Male 225 lb 8/12/2009 Consumer United States
Primary
Concomitant
Rash Generalised Other Serious Male 8/13/2009 Physician United States
Primary
Concomitant
Thrombocytopenia Hospitalization 7/10/2009 80 Female 148 lb 8/4/2009 Physician United States
Primary
Secondary
Concomitant
Palpitations 7/5/2009 51 Female 7/22/2009 Consumer United States
Primary
Concomitant
Thrombocytopenia Other Serious 5/26/2009 79 Female 148 lb 8/18/2009 Physician United States
Primary
Secondary
Concomitant
Skin Burning Sensation 3/1/2009 Male 178 lb 8/21/2009 Other Health Professional United States
Primary
Concomitant
Flushing Male 8/22/2009 United States
Primary
Concomitant
Burning Sensation Male 8/22/2009 United States
Primary
Concomitant
Skin Tightness Female 8/22/2009 Consumer United States
Primary
Concomitant
Hot Flush Male 8/22/2009 United States
Primary
Concomitant
Insomnia 12/1/2008 Female 155 lb 8/22/2009 Consumer United States
Primary
Concomitant
Rash Generalised Disability Male 311 lb 8/24/2009 Physician United States
Primary
Concomitant
Thinking Abnormal 3/3/2009 Male 8/22/2009 United States
Primary
Concomitant
Pruritus 6/10/2009 Male 172 lb 8/22/2009 United States
Primary
Concomitant
Oedema Peripheral 3/1/2009 Female 8/22/2009 United States
Primary
Concomitant
Flushing 4/1/2009 Male 150 lb 8/22/2009 United States
Primary
Concomitant
Flushing 4/1/2009 Female 200 lb 8/22/2009 United States
Primary
Concomitant
Hot Flush 6/12/2009 Female 8/22/2009 United States
Primary
Concomitant
Flushing 6/8/2009 Male 8/22/2009 United States
Primary
Concomitant
Feeling Hot Male 197 lb 8/23/2009 United States
Primary
Concomitant
Neck Pain Female 223 lb 8/23/2009 United States
Primary
Concomitant
Paraesthesia 6/1/2009 Male 195 lb 8/23/2009 United States
Primary
Concomitant
Flushing 6/1/2009 Female 195 lb 8/23/2009 United States
Primary
Concomitant
Pain 7/7/2009 Male 170 lb 8/23/2009 United States
Primary
Concomitant
Renal Artery Occlusion Other Serious 7/1/2000 Female 8/26/2009 Physician United States
Primary
Concomitant
Pain 5/6/2009 Female 202 lb 8/29/2009 United States
Primary
Concomitant
Flushing 6/1/2009 Female 8/29/2009 United States
Primary
Concomitant
Hospitalisation Other Serious 8/1/2005 Male 8/27/2009 Physician United States
Primary
Secondary
Concomitant
Syncope Other Serious 8/22/2009 Female 145 lb 9/11/2009 Other Health Professional United States
Primary
Concomitant
Hemiparesis Other Serious Male 9/16/2009 Physician United States
Primary
Secondary
Concomitant
Skin Papilloma Female 127 lb 9/18/2009 Consumer United States
Primary
Concomitant
Tooth Infection Other Serious 12/1/2008 Male 311 lb 9/22/2009 United States
Primary
Concomitant
Weight Increased 12/1/2000 50 Male 275 lb 9/23/2009 United States
Primary
Concomitant
Increased Upper Airway Secretion 1/1/2008 73 Female 9/28/2009 Physician
Primary
Concomitant
White Clot Syndrome Other Serious 11/11/2007 67 Male 179 lb 9/29/2009 Lawyer United States
Primary
Concomitant
Syncope Other Serious 8/22/2009 Female 145 lb 9/30/2009 United States
Primary
Concomitant
Serratia Infection Other Serious 1/1/2008 76 Male 214 lb 10/12/2009 Other Health Professional United States
Primary
Concomitant
Diarrhoea Hospitalization 9/11/2009 77 Female 10/16/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Thrombotic Thrombocytopenic Purpura Life Threatening 9/10/2009 68 Male 270 lb 10/22/2009 Physician
Primary
Concomitant
In-stent Coronary Artery Restenosis Hospitalization 8/1/2009 Female 10/26/2009 Consumer United States
Primary
Concomitant
Weight Decreased Other Serious 11/1/2008 Female 220 lb 10/27/2009 Consumer United States
Primary
Concomitant
Convulsion Other Serious Female 11/13/2009 Physician South Africa
Primary
Concomitant
Thrombocytopenia Other Serious 1/1/2008 55 Female 141 lb 11/19/2009 Lawyer United States
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2007 Female 137 lb 11/25/2009 Physician United States
Primary
Concomitant
Hallucination Other Serious 1/1/2009 Female 155 lb 12/8/2009 Consumer United States
Primary
Concomitant
Open Wound 6/15/2008 66 Male 12/11/2009 Consumer United States
Primary
Concomitant
Hallucination Other Serious 1/1/2009 Female 155 lb 12/16/2009 Consumer United States
Primary
Concomitant
High Density Lipoprotein Decreased Male 251 lb 12/16/2009 Other Health Professional United States
Primary
Concomitant
Intervertebral Disc Protrusion Disability 12/18/2009 Consumer United States
Primary
Concomitant
Red Blood Cell Sedimentation Rate Increased Hospitalization 9/29/2009 65 Female 300 lb 12/17/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Wrist Fracture Hospitalization 12/4/2009 Female 12/23/2009 Consumer United States
Primary
Concomitant
Retching 1/3/2009 67 Male 1/4/2010 Consumer United States
Primary
Concomitant
Gout 3/1/2009 71 Male 1/4/2010 Pharmacist United States
Primary
Concomitant
Urine Abnormality 4/5/2009 68 Female 135 lb 1/4/2010 Consumer United States
Primary
Concomitant
Vaginal Ulceration 5/13/2009 55 Female 1/4/2010 Consumer United States
Primary
Concomitant
High Density Lipoprotein Decreased 5/26/2009 58 Female 1/4/2010 Consumer United States
Primary
Concomitant
Eructation 6/1/2009 59 Male 1/4/2010 Consumer United States
Primary
Concomitant
Muscular Weakness Hospitalization 1/1/2007 Male 180 lb 1/13/2010 Consumer United States
Primary
Concomitant
Neutropenia Life Threatening 12/14/2009 Male 184 lb 1/20/2010 United States
Primary
Secondary
Concomitant
Multiple Sclerosis Relapse Other Serious Female 1/20/2010 Canada
Primary
Concomitant
Blood Pressure Increased Hospitalization Female 1/28/2010 Pharmacist United States
Primary
Concomitant
Pain 8/1/2009 Male 220 lb 1/29/2010 United States
Primary
Concomitant
Fall 9/9/2009 Male 250 lb 1/29/2010 United States
Primary
Concomitant
Injection Site Urticaria Male 245 lb 1/30/2010 United States
Primary
Concomitant
Tinnitus 11/3/2009 Female 2/2/2010 Physician
Primary
Concomitant
Neutropenia Other Serious 12/14/2009 Male 184 lb 2/9/2010 United States
Primary
Secondary
Concomitant
Pruritus Hospitalization 1/1/2009 Male 2/10/2010 United States
Primary
Concomitant
Tooth Infection Other Serious 8/1/2008 Male 311 lb 2/10/2010 United States
Primary
Concomitant
Septic Shock Hospitalization Female 2/11/2010 Physician United States
Primary
Concomitant
Renal Disorder Other Serious Female 148 lb 2/17/2010 Brazil
Primary
Concomitant
Ventricular Extrasystoles Other Serious 9/17/2006 Female 2/25/2010 Physician United States
Primary
Secondary
Concomitant
Dyspnoea Exertional 11/1/2009 Male 2/26/2010 Consumer
Primary
Concomitant
Tooth Repair Other Serious 4/7/2005 Male 3/1/2010 Other Health Professional United States
Primary
Concomitant
Death Death Male 260 lb 3/1/2010 Consumer United States
Primary
Concomitant
Thrombocytopenia Other Serious 1/1/2008 55 Female 141 lb 3/2/2010 Other Health Professional United States
Primary
Concomitant
Death Death 2/17/2010 Female 3/3/2010 Consumer United States
Primary
Concomitant
Cardiac Arrest Death 2/22/2010 Male 260 lb 3/9/2010 Consumer United States
Primary
Concomitant
Myocardial Infarction Hospitalization 2/23/2010 86 Male 3/8/2010 Consumer United States
Primary
Concomitant
Loss Of Consciousness Hospitalization 2/16/2010 69 Female 3/9/2010 Consumer United States
Primary
Concomitant
Renal Failure Acute Death 2/22/2010 Male 260 lb 3/16/2010 Consumer United States
Primary
Concomitant
Syncope Other Serious 5/1/2006 Female 206 lb 3/17/2010 Physician United States
Primary
Concomitant
Colon Cancer Metastatic Death Female 3/17/2010 Physician United States
Primary
Concomitant
Tooth Repair Other Serious 4/7/2005 Male 3/19/2010 Other Health Professional United States
Primary
Concomitant
Tooth Repair Other Serious 4/7/2005 Male 3/26/2010 Other Health Professional United States
Primary
Concomitant
Liver Injury 6/19/2008 72 Female 6/6/2009 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2003 Female 220 lb 3/30/2010 Consumer United States
Primary
Secondary
Concomitant
Dyspnoea Exertional 11/1/2009 82 Male 205 lb 4/1/2010 Consumer
Primary
Concomitant
Muscular Weakness Other Serious 3/1/2010 67 Female 120 lb 4/2/2010 Consumer United States
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2003 56 Female 220 lb 4/5/2010 Physician United States
Primary
Secondary
Concomitant
Muscular Weakness Hospitalization 1/1/2007 62 Male 180 lb 4/5/2010 Physician United States
Primary
Concomitant
Tendon Rupture Other Serious 3/3/2010 81 Female 160 lb 3/25/2010 Physician United States
Primary
Concomitant
Haemorrhoidal Haemorrhage Male 4/12/2010 Other Health Professional United States
Primary
Concomitant
Anosmia 8/1/2009 52 Female 200 lb 3/15/2010 United States
Primary
Concomitant
Bone Density Decreased Other Serious 2/1/2010 59 Female 203 lb 4/14/2010 Other Health Professional United States
Primary
Concomitant
Myocardial Infarction Other Serious 2/23/2010 86 Male 4/20/2010 Physician United States
Primary
Concomitant
Weight Increased 9/1/2009 68 Female 3/18/2010 Consumer United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 53 Female 4/15/2010 United States
Primary
Concomitant
Tearfulness Other Serious 1/1/2010 23 Male 4/23/2010 Consumer United States
Primary
Concomitant
Death Death 4/15/2010 73 Male 4/26/2010 Consumer United States
Primary
Concomitant

Drug Data