Blinded Enalapril Comp-Ena+ combined with Comparator Enalapril

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Productive Cough Hospitalization 6/17/2009 Female 152 lb 6/26/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Productive Cough Hospitalization 6/17/2009 Female 152 lb 9/9/2009 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Mean Cell Volume Decreased Hospitalization 9/8/2008 Female 110 lb 9/16/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Tachycardia Hospitalization 10/27/2009 Male 198 lb 11/5/2009 Physician Denmark
Primary
Secondary
Concomitant
Tachycardia Other Serious 10/27/2009 Male 198 lb 12/9/2009 Physician Denmark
Primary
Secondary
Concomitant
Scar Hospitalization 11/19/2009 Male 194 lb 12/11/2009 Physician Japan
Primary
Secondary
Concomitant
Pelvic Fracture Hospitalization 11/21/2009 Female 151 lb 12/11/2009 Physician Sweden
Primary
Secondary
Pneumonia Hospitalization 12/8/2009 Male 12/15/2009 Physician United States
Primary
Secondary
Tachycardia Other Serious 10/27/2009 Male 198 lb 12/22/2009 Physician Denmark
Primary
Secondary
Concomitant
Scar Hospitalization 11/19/2009 Male 194 lb 12/23/2009 Physician Japan
Primary
Secondary
Concomitant
Skin Warm Hospitalization 8/20/2009 Male 183 lb 12/23/2009 Physician Germany
Primary
Secondary
Concomitant
Pelvic Fracture Hospitalization 11/21/2009 Female 151 lb 12/29/2009 Physician Sweden
Primary
Secondary
Hyponatraemia Other Serious 12/16/2009 Male 251 lb 1/8/2010 Physician Switzerland
Primary
Secondary
Pneumonia Hospitalization 12/8/2009 Male 1/20/2010 Physician United States
Primary
Secondary
Ventricular Arrhythmia Hospitalization 10/30/2009 Female 158 lb 1/21/2010 Physician Brazil
Primary
Secondary
Concomitant
Hyponatraemia Other Serious 12/16/2009 Male 251 lb 1/22/2010 Physician Switzerland
Primary
Secondary
White Blood Cell Count Increased Life Threatening 11/20/2009 Female 82 lb 2/3/2010 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea Other Serious 1/29/2010 Male 176 lb 2/5/2010 Physician Taiwan, Province Of China
Primary
Secondary
Dyspnoea Exertional Hospitalization 1/1/2010 Male 172 lb 2/9/2010 Physician Italy
Primary
Secondary
Vertigo Hospitalization 1/5/2010 Male 181 lb 2/15/2010 Physician Germany
Primary
Secondary
Concomitant
Ventricular Dysfunction Hospitalization 1/24/2010 Male 247 lb 2/15/2010 Physician Russian Federation
Primary
Secondary
Mean Cell Volume Decreased Hospitalization 9/8/2008 Female 110 lb 2/18/2010 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Hyperkalaemia Life Threatening 1/29/2010 Male 203 lb 2/18/2010 Physician Poland
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 1/11/2010 Male 139 lb 2/18/2010 Physician Taiwan, Province Of China
Primary
Secondary
Pulmonary Congestion Other Serious 1/29/2010 Male 176 lb 2/18/2010 Physician Taiwan, Province Of China
Primary
Secondary
Urinary Incontinence Hospitalization 2/6/2010 Male 231 lb 2/19/2010 Physician Romania
Primary
Secondary
Concomitant
Weight Increased Other Serious 7/30/2009 Male 206 lb 2/19/2010 Physician Sweden
Primary
Secondary
Pancreatitis Acute Hospitalization 2/12/2010 Male 187 lb 2/19/2010 Physician Sweden
Primary
Secondary
Dyspnoea Exertional Hospitalization 1/2/2010 Male 172 lb 2/19/2010 Physician Italy
Primary
Secondary
Tachypnoea Hospitalization 1/11/2010 Male 139 lb 2/22/2010 Physician Taiwan, Province Of China
Primary
Secondary
Vertigo Hospitalization 1/5/2010 Male 181 lb 2/22/2010 Physician Germany
Primary
Secondary
Concomitant
Ventricular Dysfunction Hospitalization 1/24/2010 Male 247 lb 2/22/2010 Physician Russian Federation
Primary
Secondary
Urinary Incontinence Hospitalization 2/6/2010 Male 231 lb 2/23/2010 Physician Romania
Primary
Secondary
Concomitant
Vertigo Hospitalization 1/5/2010 Male 181 lb 2/26/2010 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 2/28/2010 Male 196 lb 3/4/2010 Physician Czech Republic
Primary
Secondary
Concomitant
Tachypnoea Hospitalization 1/11/2010 Male 139 lb 3/5/2010 Physician Taiwan, Province Of China
Primary
Secondary
Pancreatitis Acute Hospitalization 2/12/2010 Male 187 lb 3/8/2010 Physician Sweden
Primary
Secondary
Concomitant
Disease Progression Hospitalization 3/2/2010 Male 195 lb 3/11/2010 Physician Argentina
Primary
Secondary
Nocturnal Dyspnoea Hospitalization 1/11/2010 Male 215 lb 3/12/2010 Physician China
Primary
Secondary
Loss Of Consciousness Life Threatening 3/6/2010 Male 177 lb 3/12/2010 Physician Russian Federation
Primary
Secondary
Concomitant
Hyperkalaemia Hospitalization 1/7/2010 Male 169 lb 3/15/2010 Physician Denmark
Primary
Secondary
Concomitant
Scar Other Serious 11/19/2009 Male 194 lb 3/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 3/3/2010 Male 229 lb 3/17/2010 Physician Ireland
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization 2/28/2010 Male 196 lb 3/18/2010 Physician Czech Republic
Primary
Secondary
Concomitant
Urinary Incontinence Hospitalization 2/6/2010 Male 231 lb 3/19/2010 Physician Romania
Primary
Secondary
Concomitant
Weight Increased Hospitalization 3/2/2010 Male 195 lb 3/23/2010 Physician Argentina
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 3/15/2010 Male 3/24/2010 Physician Japan
Primary
Secondary
Stridor Hospitalization 3/16/2010 Female 157 lb 3/24/2010 Physician Germany
Primary
Secondary
Concomitant
Urinary Incontinence Hospitalization 2/6/2010 Male 231 lb 3/25/2010 Physician Romania
Primary
Secondary
Concomitant
Ventricular Dysfunction Hospitalization 1/24/2010 Male 247 lb 3/26/2010 Physician Russian Federation
Primary
Secondary
Ventricular Extrasystoles Life Threatening 3/6/2010 Male 177 lb 3/26/2010 Physician Russian Federation
Primary
Secondary
Concomitant
Vomiting Other Serious 3/10/2010 Female 161 lb 3/31/2010 Physician Peru
Primary
Secondary
Concomitant
Tachycardia Hospitalization 3/3/2010 71 Male 229 lb 4/6/2010 Physician Ireland
Primary
Secondary
Concomitant
Vomiting Other Serious 3/10/2010 65 Female 161 lb 4/6/2010 Physician Peru
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 3/3/2010 47 Male 132 lb 4/8/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Other Serious 3/10/2010 65 Female 161 lb 4/12/2010 Physician Peru
Primary
Secondary
Concomitant
Overdose Other Serious Male 177 lb 4/13/2010 Physician Germany
Primary
Secondary
Vertigo Hospitalization 3/26/2010 79 Male 179 lb 4/16/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Cardiac Failure Acute Hospitalization 4/16/2010 Physician Italy
Primary
Secondary
Orthopnoea Hospitalization 4/11/2010 66 Male 122 lb 4/16/2010 Physician Taiwan, Province Of China
Primary
Secondary
Rales Hospitalization 1/2/2010 66 Male 172 lb 4/20/2010 Physician Italy
Primary
Secondary
Renal Failure Other Serious Male 4/20/2010 Physician Germany
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization 2/16/2010 78 Male 188 lb 4/23/2010 Physician Sweden
Primary
Secondary
Renal Failure Other Serious 4/13/2010 Male 4/23/2010 Physician Germany
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 4/17/2010 87 Male 165 lb 4/26/2010 Physician Canada
Primary
Secondary
Overdose Other Serious Male 177 lb 4/26/2010 Physician Germany
Primary
Secondary
Disease Progression Hospitalization 11/24/2009 72 Male 226 lb 4/26/2010 Physician Germany
Primary
Secondary
Orthopnoea Hospitalization 4/11/2010 66 Male 122 lb 4/27/2010 Physician Taiwan, Province Of China
Primary
Secondary
Orthopnoea Hospitalization 4/11/2010 66 Male 122 lb 4/27/2010 Physician Taiwan, Province Of China
Primary
Secondary
Bronchial Neoplasm Other Serious 4/16/2010 52 Male 227 lb 4/29/2010 Physician Austria
Primary
Secondary
Resuscitation Life Threatening 4/26/2010 72 Male 4/30/2010 Physician France
Primary
Secondary
Sepsis Hospitalization 11/24/2009 72 Male 226 lb 4/30/2010 Physician Germany
Primary
Secondary
Resuscitation Life Threatening 4/26/2010 72 Male 4/30/2010 Physician France
Primary
Secondary
Dyspnoea Paroxysmal Nocturnal Hospitalization 4/4/2010 66 Male 111 lb 5/1/2010 Physician China
Primary
Secondary
Coronary Artery Disease Hospitalization 2/16/2010 78 Male 188 lb 5/5/2010 Physician Sweden
Primary
Secondary
Vertigo Hospitalization 3/26/2010 79 Male 179 lb 5/6/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Concomitant
Low Cardiac Output Syndrome Hospitalization 4/18/2010 80 Male 168 lb 5/6/2010 Physician Italy
Primary
Secondary
Vertigo Hospitalization Female 205 lb 5/6/2010 Physician Germany
Primary
Secondary
Concomitant
Ventricular Dysfunction Hospitalization 1/24/2010 54 Male 247 lb 5/7/2010 Physician Russian Federation
Primary
Secondary
Disease Progression Hospitalization Male 153 lb 5/7/2010 Physician Italy
Primary
Secondary
Myocardial Infarction Hospitalization 4/17/2010 87 Male 165 lb 5/12/2010 Physician Canada
Primary
Secondary
Restlessness Hospitalization 4/11/2010 79 Male 148 lb 5/13/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperkalaemia Life Threatening 1/29/2010 65 Male 203 lb 5/13/2010 Physician Poland
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 3/3/2010 47 Male 132 lb 5/17/2010 Physician Japan
Primary
Secondary
Concomitant
Scar Other Serious 11/19/2009 72 Male 194 lb 5/20/2010 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/19/2010 72 Male 123 lb 5/24/2010 Physician Japan
Primary
Secondary
Concomitant
Colonic Polyp Hospitalization 3/29/2010 16 Female 121 lb 5/25/2010 Physician Canada
Primary
Secondary
Weight Increased Hospitalization 5/3/2010 49 Male 223 lb 5/26/2010 Physician Denmark
Primary
Secondary
Concomitant
Vertigo Hospitalization 2/20/2004 61 Male 165 lb 5/28/2010 Physician Czech Republic
Primary
Secondary
Renal Failure Other Serious 4/16/2010 Male 5/28/2010 Physician Germany
Primary
Secondary
Concomitant
Vertigo Hospitalization Female 205 lb 5/28/2010 Physician Germany
Primary
Secondary
Concomitant
Palpitations Hospitalization 5/12/2010 73 Male 154 lb 6/1/2010 Physician China
Primary
Secondary
Concomitant
Bronchial Neoplasm Hospitalization 4/16/2010 52 Male 227 lb 6/2/2010 Physician Austria
Primary
Secondary
Syncope Hospitalization 5/13/2010 58 Male 154 lb 6/2/2010 Physician Belgium
Primary
Secondary
Concomitant
Rales Hospitalization 1/2/2010 66 Male 172 lb 6/4/2010 Physician Italy
Primary
Secondary
Pulmonary Oedema Hospitalization Male 196 lb 6/4/2010 Physician Austria
Primary
Secondary
Weight Increased Hospitalization 5/3/2010 49 Male 223 lb 6/4/2010 Physician Denmark
Primary
Secondary
Concomitant
Ventricular Dysfunction Hospitalization 1/24/2010 54 Male 247 lb 6/10/2010 Physician Russian Federation
Primary
Secondary
Coronary Artery Restenosis Other Serious 6/1/2010 74 Male 115 lb 6/10/2010 Physician Japan
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 5/18/2010 62 Male 179 lb 6/14/2010 Physician Germany
Primary
Secondary
Weight Increased Other Serious 4/19/2010 72 Male 123 lb 6/14/2010 Physician Japan
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 6/1/2010 59 Male 6/15/2010 Physician Canada
Primary
Secondary
Renal Impairment Hospitalization 6/9/2010 53 Male 225 lb 6/17/2010 Physician Austria
Primary
Secondary
Vomiting Hospitalization 5/10/2010 58 Male 154 lb 6/18/2010 Physician Belgium
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 5/1/2010 73 Female 179 lb 6/21/2010 Physician Czech Republic
Primary
Secondary
Renal Impairment Other Serious 4/18/2010 80 Male 168 lb 6/22/2010 Physician Italy
Primary
Secondary
Concomitant
Cardiac Failure Hospitalization 6/14/2010 62 Male 6/22/2010 Physician Japan
Primary
Secondary
Concomitant
Ventricular Extrasystoles Other Serious 6/1/2010 59 Male 6/22/2010 Physician Canada
Primary
Secondary
Urine Output Decreased Other Serious 1/6/2010 47 Male 132 lb 6/24/2010 Physician Japan
Primary
Secondary
Concomitant
Overdose Other Serious Male 177 lb 6/24/2010 Physician Germany
Primary
Secondary
Coronary Artery Restenosis Other Serious 6/1/2010 74 Male 115 lb 6/25/2010 Physician Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 1/2/2010 66 Male 172 lb 6/29/2010 Physician Italy
Primary
Secondary
Ventricular Extrasystoles Other Serious 6/1/2010 59 Male 6/28/2010 Physician Canada
Primary
Secondary
Thrombosis Hospitalization 5/1/2010 73 Female 179 lb 7/5/2010 Physician Czech Republic
Primary
Secondary
Concomitant
Dyspnoea Other Serious 7/13/2010 Physician Czech Republic
Primary
Secondary
Oedema Other Serious 6/14/2010 62 Male 7/13/2010 Physician Japan
Primary
Secondary
Concomitant
Treatment Noncompliance Hospitalization 6/7/2010 Male 153 lb 7/13/2010 Physician Brazil
Primary
Secondary
Concomitant
Pulmonary Oedema Hospitalization Male 196 lb 7/14/2010 Physician Austria
Primary
Secondary
Rectal Haemorrhage Other Serious 3/17/2010 67 Male 155 lb 7/15/2010 Physician France
Primary
Secondary
Dyspnoea Hospitalization 7/6/2010 72 Male 7/16/2010 Physician Netherlands
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 1/2/2010 66 Male 172 lb 7/16/2010 Physician Italy
Primary
Secondary
Dyspnoea Hospitalization 5/10/2010 81 Male 256 lb 7/16/2010 Physician United States
Primary
Secondary
Concomitant
Drug Ineffective Hospitalization 5/18/2010 62 Male 179 lb 7/16/2010 Physician Germany
Primary
Secondary
Dyspnoea Hospitalization 5/10/2010 81 Male 256 lb 7/17/2010 Physician United States
Primary
Secondary
Concomitant
Resuscitation Life Threatening 4/26/2010 72 Male 7/18/2010 Physician France
Primary
Secondary
Pulmonary Oedema Hospitalization Male 196 lb 7/20/2010 Physician Austria
Primary
Secondary
Treatment Noncompliance Other Serious 6/7/2010 60 Male 153 lb 7/20/2010 Physician Brazil
Primary
Secondary
Concomitant
Tachycardia Hospitalization 3/3/2010 71 Male 229 lb 7/23/2010 Physician Ireland
Primary
Secondary
Concomitant
Scar Other Serious 11/19/2009 72 Male 194 lb 7/23/2010 Physician Japan
Primary
Secondary
Concomitant
Oedema Other Serious 6/14/2010 62 Male 7/23/2010 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Other Serious 1/6/2010 47 Male 132 lb 7/26/2010 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 7/6/2010 72 Male 7/30/2010 Physician Netherlands
Primary
Secondary
Concomitant
Vascular Occlusion Hospitalization 6/9/2010 53 Male 225 lb 8/3/2010 Physician Austria
Primary
Secondary
Ischaemic Stroke Life Threatening 2/19/2010 51 Male 150 lb 8/4/2010 Physician Brazil
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 5/10/2010 81 Male 256 lb 7/30/2010 Physician United States
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 7/22/2010 79 Male 108 lb 8/5/2010 Physician Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 7/22/2010 79 Male 108 lb 8/10/2010 Physician Japan
Primary
Secondary
Concomitant
Scar Other Serious 11/19/2009 72 Male 194 lb 8/11/2010 Physician Japan
Primary
Secondary
Concomitant
Hyperkalaemia Life Threatening 2/19/2010 51 Male 150 lb 8/12/2010 Physician Brazil
Primary
Secondary
Concomitant
Ventricular Tachycardia Hospitalization 1/2/2010 66 Male 172 lb 8/12/2010 Physician Italy
Primary
Secondary
Sudden Death Death 7/1/2010 60 Male 200 lb 8/12/2010 Physician Russian Federation
Primary
Secondary
Disease Progression Hospitalization 7/1/2010 62 223 lb 8/12/2010 Physician Brazil
Primary
Secondary
Concomitant
Vomiting Other Serious 11/19/2009 72 Male 194 lb 8/12/2010 Physician Japan
Primary
Secondary
Concomitant
Dyspnoea Hospitalization 5/10/2010 81 Male 256 lb 8/13/2010 Physician United States
Primary
Secondary
Concomitant
Cardiopulmonary Failure Death 8/3/2010 59 Male 143 lb 8/13/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Cardiac Pacemaker Insertion Hospitalization 8/9/2010 66 Male 161 lb 8/21/2010 Physician Canada
Primary
Secondary
Oedema Other Serious 6/14/2010 62 Male 8/20/2010 Physician Japan
Primary
Secondary
Concomitant
Cardiac Pacemaker Insertion Hospitalization 8/9/2010 66 Male 161 lb 8/20/2010 Physician Canada
Primary
Secondary
Cardiopulmonary Failure Death 8/3/2010 59 Male 143 lb 8/20/2010 Physician Slovakia (Slovak Republic)
Primary
Secondary
Left Ventricular Failure Hospitalization 4/21/2010 8/23/2010 Physician Czech Republic
Primary
Secondary

Drug Data