Lovaza combined with Potassium Chloride

Reports:


Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Off Label Use Hospitalization 1/1/2007 74 Male 240 lb 12/11/2007 United States
Primary
Secondary
Concomitant
Off Label Use 11/1/2006 66 Male 110 lb 12/10/2007 United States
Primary
Concomitant
Treatment Noncompliance Hospitalization 1/1/2007 74 Male 240 lb 1/15/2008 United States
Primary
Secondary
Concomitant
Therapeutic Response Unexpected With Drug Substitution Required Intervention 6/1/2007 Male 2/8/2008 Physician United States
Primary
Concomitant
Vomiting 1/30/2008 66 Female 170 lb 3/11/2008 Physician United States
Primary
Concomitant
Pain In Extremity Other Serious 3/1/2007 57 Female 172 lb 3/14/2008 United States
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 1/1/2007 57 Female 172 lb 4/22/2008 Consumer United States
Primary
Secondary
Concomitant
Urinary Tract Infection 3/1/2008 70 Female 7/7/2008 Consumer United States
Primary
Concomitant
Pain Other Serious 6/1/2008 44 Female 173 lb 8/5/2008 Other Health Professional United States
Primary
Concomitant
Vomiting Hospitalization 3/17/2008 71 Female 152 lb 8/26/2008 Physician United States
Primary
Secondary
Concomitant
Weight Increased Hospitalization 5/1/2008 76 Male 195 lb 9/3/2008 United States
Primary
Secondary
Concomitant
Pancreatitis Other Serious 65 Female 10/7/2008 Physician United States
Primary
Concomitant
Weight Decreased Hospitalization 5/1/2008 76 Male 195 lb 10/6/2008 United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 65 Female 217 lb 10/29/2008 Physician United States
Primary
Concomitant
White Blood Cell Count Increased Hospitalization 1/1/2008 Female 11/21/2008 Consumer United States
Primary
Concomitant
Headache 3/1/2008 200 lb 12/4/2008 Consumer United States
Primary
Concomitant
Muscle Spasms Other Serious 12/6/2008 79 Female 12/11/2008 Consumer United States
Primary
Concomitant
Muscle Spasms 3/1/2008 Female 12/16/2008 Consumer United States
Primary
Concomitant
Sinusitis 11/3/2007 68 Female 12/16/2008 Consumer United States
Primary
Concomitant
Rheumatoid Arthritis Other Serious 10/1/2007 Male 172 lb 1/12/2009 Physician United States
Primary
Concomitant
Application Site Reaction 1/1/2008 68 Female 220 lb 1/13/2009 Consumer United States
Primary
Concomitant
Heart Rate Increased Other Serious 5/1/2008 Female 270 lb 2/17/2009 Consumer United States
Primary
Concomitant
Flushing 12/13/2008 Female 2/24/2009 Other Health Professional United States
Primary
Concomitant
Liver Function Test Abnormal 12/5/2008 Male 2/24/2009 United States
Primary
Concomitant
Vitamin D Decreased 9/1/2008 Female 2/24/2009 United States
Primary
Concomitant
Stevens-johnson Syndrome Hospitalization 7/1/2008 Male 261 lb 2/27/2009 Consumer United States
Primary
Concomitant
Wrong Technique In Drug Usage Process Hospitalization 12/1/2008 74 Female 160 lb 3/19/2009 Physician United States
Primary
Secondary
Concomitant
Polydipsia Life Threatening 12/5/2007 63 Female 3/17/2009 United Kingdom
Primary
Concomitant
Ulcer Other Serious 3/2/2004 Female 3/25/2009 Consumer United States
Primary
Concomitant
Skin Discolouration Other Serious 2/28/2009 Male 206 lb 3/25/2009 Other Health Professional United States
Primary
Concomitant
Wrong Technique In Drug Usage Process Hospitalization 12/1/2008 74 Female 160 lb 3/27/2009 Physician United States
Primary
Secondary
Concomitant
Malaise Life Threatening 12/5/2007 63 Female 4/6/2009 Other Health Professional United Kingdom
Primary
Concomitant
Therapeutic Response Decreased Other Serious 1/1/2008 Male 4/8/2009 Physician United States
Primary
Concomitant
Skin Discolouration Other Serious 2/28/2009 Male 206 lb 4/17/2009 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Hospitalization 4/4/2009 Female 119 lb 4/20/2009 Other Health Professional United States
Primary
Concomitant
Weight Increased Other Serious 11/1/2008 Male 210 lb 4/21/2009 Consumer United States
Primary
Secondary
Concomitant
Rectal Haemorrhage Hospitalization 3/28/2009 43 Female 172 lb 4/29/2009 Consumer United States
Primary
Concomitant
Pleural Effusion Hospitalization 3/24/2009 Female 119 lb 5/5/2009 Other Health Professional United States
Primary
Concomitant
Thrombocytopenia Hospitalization 4/4/2009 Female 119 lb 5/5/2009 Other Health Professional United States
Primary
Concomitant
Myalgia 1/1/2008 52 Male 220 lb 5/1/2009 Pharmacist United States
Primary
Concomitant
Wheezing Other Serious 87 Female 5/12/2009 United States
Primary
Concomitant
Colitis Ischaemic Hospitalization 3/28/2009 43 Female 172 lb 5/19/2009 Consumer United States
Primary
Concomitant
Pleural Effusion Hospitalization 3/24/2009 Female 119 lb 5/21/2009 Other Health Professional United States
Primary
Concomitant
Vertigo 2/3/2009 73 Female 5/15/2009 United States
Primary
Concomitant
Paraesthesia Female 5/27/2009 United States
Primary
Concomitant
Heart Rate Increased Other Serious 5/1/2008 Female 270 lb 5/28/2009 Physician United States
Primary
Concomitant
Fatigue Male 265 lb 5/15/2009 Physician United States
Primary
Concomitant
Influenza Like Illness 2/1/2009 47 Female 215 lb 5/15/2009 Consumer United States
Primary
Concomitant
Hot Flush Other Serious 76 Female 6/9/2009 United States
Primary
Concomitant
Weight Increased Hospitalization 10/1/2008 Female 265 lb 6/12/2009 United States
Primary
Concomitant
Myasthenia Gravis Hospitalization 12/1/2008 Female 153 lb 6/12/2009 Consumer United States
Primary
Concomitant
Muscular Weakness Disability 1/1/2009 90 Male 6/16/2009 Consumer United States
Primary
Concomitant
Dehydration Hospitalization 4/4/2009 Female 119 lb 6/19/2009 Other Health Professional United States
Primary
Concomitant
Pleural Effusion Hospitalization 3/24/2009 Female 119 lb 6/19/2009 Other Health Professional United States
Primary
Concomitant
Wheezing 78 Female 176 lb 6/23/2009 Consumer United States
Primary
Secondary
Concomitant
Transient Ischaemic Attack Other Serious 78 Female 6/25/2009 Consumer United States
Primary
Concomitant
Ulcer Other Serious 1/1/2004 Female 7/1/2009 Consumer United States
Primary
Concomitant
International Normalised Ratio Fluctuation 78 Male 225 lb 7/22/2009 Consumer United States
Primary
Concomitant
International Normalised Ratio Fluctuation 78 Male 225 lb 7/22/2009 Consumer United States
Primary
Concomitant
Therapeutic Agent Toxicity Hospitalization 77 Female 8/4/2009 Lawyer United States
Primary
Concomitant
Surgery Death Female 8/4/2009 United States
Primary
Concomitant
Pneumonia Hospitalization 1/24/2002 45 Male 8/9/2009 United States
Primary
Concomitant
Flushing 12/1/2008 Female 8/22/2009 United States
Primary
Concomitant
Rhinorrhoea Female 8/22/2009 United States
Primary
Concomitant
Scar 2/1/2009 Female 140 lb 8/22/2009 Consumer United States
Primary
Concomitant
Flushing 5/11/2009 Male 196 lb 8/22/2009 United States
Primary
Concomitant
Paraesthesia 6/1/2009 Male 195 lb 8/23/2009 United States
Primary
Concomitant
Swollen Tongue Hospitalization 8/1/2009 Female 8/26/2009 Consumer United States
Primary
Concomitant
Paraesthesia Female 158 lb 8/29/2009 United States
Primary
Concomitant
Anxiety 7/1/2009 Male 236 lb 8/29/2009 United States
Primary
Concomitant
Urticaria 7/1/2009 Male 220 lb 8/29/2009 United States
Primary
Concomitant
Flushing 6/1/2009 Female 8/29/2009 United States
Primary
Concomitant
Skin Ulcer Other Serious 10/1/2007 Female 134 lb 9/1/2009 Lawyer United States
Primary
Secondary
Concomitant
Syncope Hospitalization 45 Male 213 lb 8/28/2009 United States
Primary
Concomitant
Ischaemia Other Serious 1/1/2006 Female 135 lb 9/9/2009 Other Health Professional United States
Primary
Concomitant
Unevaluable Event Hospitalization 77 Female 9/4/2009 United States
Primary
Concomitant
Syncope Hospitalization 45 Male 213 lb 9/8/2009 United States
Primary
Concomitant
Weight Decreased Hospitalization Male 9/11/2009 United States
Primary
Concomitant
Palpitations Other Serious 9/5/2009 Male 9/17/2009 Consumer United States
Primary
Concomitant
Emphysema Female 152 lb 9/19/2009 United States
Primary
Concomitant
Pulmonary Hypertension Hospitalization 6/5/2007 44 Male 213 lb 9/18/2009 United States
Primary
Concomitant
Weight Increased 12/1/2008 75 Female 156 lb 10/2/2009 United States
Primary
Concomitant
Vomiting Hospitalization 77 Female 9/25/2009 United States
Primary
Concomitant
Tricuspid Valve Disease Hospitalization 6/5/2007 44 Male 213 lb 9/25/2009 United States
Primary
Concomitant
Diarrhoea Hospitalization 9/11/2009 77 Female 10/16/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Breast Cancer Metastatic Other Serious 5/1/2009 Female 178 lb 10/23/2009 Other Health Professional United States
Primary
Concomitant
Thirst Other Serious 11/1/2007 63 Male 234 lb 10/28/2009 United States
Primary
Secondary
Concomitant
Palpitations Other Serious 9/5/2009 Male 10/28/2009 Other Health Professional United States
Primary
Concomitant
Skin Ulcer Other Serious 10/1/2007 Female 134 lb 10/29/2009 Lawyer United States
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 7/23/2009 68 Female 226 lb 10/30/2009 Physician United States
Primary
Concomitant
Lower Limb Fracture Other Serious 11/14/2008 Female 11/7/2009 Consumer United States
Primary
Concomitant
Walking Aid User Other Serious 1/1/2007 Female 11/18/2009 Consumer United States
Primary
Secondary
Concomitant
Flushing 10/1/2009 Female 225 lb 11/25/2009 United States
Primary
Concomitant
Surgery Hospitalization 1/24/2002 45 Male 11/18/2009 United States
Primary
Concomitant
Weight Increased Other Serious 1/1/2005 58 Male 254 lb 11/30/2009 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 7/23/2009 68 Female 226 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
Transfusion Other Serious 1/1/2004 Male 12/10/2009 Other Health Professional United States
Primary
Concomitant
Tachycardia Hospitalization 1/25/2008 56 Male 12/1/2009 United States
Primary
Concomitant
Weight Decreased Hospitalization 10/1/2009 Female 165 lb 12/11/2009 Consumer United States
Primary
Concomitant
Skin Discolouration Death 1/1/2009 Female 12/15/2009 Consumer United States
Primary
Concomitant
Hallucination Other Serious 1/1/2009 Female 155 lb 12/16/2009 Consumer United States
Primary
Concomitant
Tachycardia Hospitalization 1/25/2008 56 Male 12/11/2009 United States
Primary
Concomitant
Upper Respiratory Tract Infection Hospitalization 84 Female 12/11/2009 Lawyer 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
Urinary Tract Infection Hospitalization 1/1/2009 61 Female 12/29/2009 Physician United States
Primary
Concomitant
Urine Abnormality 4/5/2009 68 Female 135 lb 1/4/2010 Consumer United States
Primary
Concomitant
Wrong Technique In Drug Usage Process 10/20/2009 43 Female 1/4/2010 Consumer United States
Primary
Concomitant
Pancytopenia Other Serious 9/16/2009 Male 1/8/2010 Physician United States
Primary
Concomitant
Infusion Site Extravasation Hospitalization 12/2/2009 Female 231 lb 1/11/2010 Pharmacist United States
Primary
Concomitant
Neutropenia Life Threatening 12/14/2009 Male 184 lb 1/20/2010 United States
Primary
Secondary
Concomitant
Upper Respiratory Tract Infection Hospitalization 84 Female 1/7/2010 United States
Primary
Concomitant
Surgery Hospitalization 66 Male 1/12/2010 Lawyer United States
Primary
Concomitant
Wound Infection Other Serious 1/1/2007 Female 1/19/2010 Physician United States
Primary
Secondary
Concomitant
Pancytopenia Other Serious 9/16/2009 Male 1/26/2010 Physician United States
Primary
Concomitant
Neutropenia Other Serious 12/14/2009 Male 184 lb 2/9/2010 United States
Primary
Secondary
Concomitant
Transfusion Other Serious 1/1/2004 Male 2/26/2010 Other Health Professional United States
Primary
Concomitant
Adverse Event Female 207 lb 3/5/2010 Pharmacist United States
Primary
Secondary
Concomitant
Death Death 3/26/2010 57 Female 240 lb 4/2/2010 Other Health Professional United States
Primary
Concomitant
Renal Failure Hospitalization Female 245 lb 4/7/2010 Physician United States
Primary
Concomitant
Renal Failure Acute Hospitalization Female 259 lb 4/13/2010 Physician United States
Primary
Concomitant
Weight Increased Hospitalization 53 Female 4/15/2010 United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 1/1/2009 61 Female 198 lb 5/5/2010 Physician United States
Primary
Concomitant
Thrombocytopenia Other Serious 3/12/2010 85 Male 212 lb 5/24/2010 Pharmacist United States
Primary
Concomitant
Hypertension Other Serious 1/1/2008 65 Male 258 lb 6/15/2010 Lawyer United States
Primary
Concomitant
Squamous Cell Carcinoma Of Skin Other Serious 7/14/2006 59 Female 127 lb 6/29/2010 Physician United States
Primary
Secondary
Concomitant
Vision Blurred 10/22/2007 79 Male 170 lb 6/29/2010 Other Health Professional United States
Primary
Concomitant
Libido Decreased 6/1/2010 61 Male 7/7/2010 Consumer
Primary
Concomitant
Death Death 7/2/2010 69 Female 7/8/2010 Consumer United States
Primary
Concomitant
Syncope Female 7/8/2010 Consumer United States
Primary
Concomitant
Vomiting 6/25/2007 49 Female 160 lb 7/14/2010 Consumer United States
Primary
Concomitant
Pyrexia Hospitalization 2/1/2009 59 Male 185 lb 7/16/2010 Physician United States
Primary
Concomitant
Tremor Other Serious 12/21/2007 55 Female 140 lb 7/17/2010 Consumer United States
Primary
Concomitant
Somnolence Other Serious 9/8/2009 42 Female 250 lb 5/18/2010 United States
Primary
Concomitant
Pleural Effusion Hospitalization 3/24/2009 72 Female 119 lb 8/2/2010 Other Health Professional United States
Primary
Concomitant
Transfusion Other Serious 1/1/2004 77 Male 7/28/2010 Other Health Professional United States
Primary
Concomitant
Pulmonary Embolism Other Serious 1/1/2008 65 Male 258 lb 8/12/2010 Lawyer United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process 7/1/2009 61 Female 185 lb 8/27/2010 United States
Primary
Concomitant
Rash 8/1/2009 74 Female 145 lb 8/28/2010 United States
Primary
Concomitant
Diarrhoea 3/14/2010 59 Male 346 lb 8/28/2010 United States
Primary
Concomitant
Pruritus 5/1/2010 62 Male 200 lb 8/29/2010 Consumer United States
Primary
Concomitant
Muscle Spasms 5/1/2010 48 Male 8/29/2010 Consumer United States
Primary
Concomitant
Vomiting Hospitalization 8/31/2010 65 Male 10/7/2010 Consumer United States
Primary
Concomitant
Death Death Female 145 lb 10/19/2010 Consumer United States
Primary
Concomitant
Coronary Artery Disease Life Threatening 8/30/2010 67 Male 10/22/2010 Physician United States
Primary
Secondary
Concomitant
Wound Other Serious 3/13/2003 66 Male 174 lb 10/27/2010 United States
Primary
Concomitant
Product Quality Issue 66 Female 10/27/2010 Consumer United States
Primary
Concomitant
Erythema 75 Male 10/13/2010 Consumer United States
Primary
Secondary
Concomitant
Product Quality Issue 59 Female 10/13/2010 Consumer United States
Primary
Concomitant