Amlodipine Besylate combined with Isosorbide Mononitrate

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Respiratory Failure Hospitalization 2/23/2005 Female 121 lb 1/3/2006 Other Health Professional
Primary
Secondary
Concomitant
Interacting
Syncope Vasovagal Other Serious 8/22/2002 63 Male 2/8/2006 Other Health Professional
Primary
Concomitant
Weight Increased Hospitalization 7/5/2004 59 Female 2/8/2006 Physician Japan
Primary
Concomitant
Gastric Cancer Other Serious 74 Female 2/15/2006 Consumer Japan
Primary
Secondary
Concomitant
Middle Insomnia 6/1/2005 58 Male 250 lb 1/5/2006 Consumer United States
Primary
Concomitant
Nausea Hospitalization 2/2/2006 73 Female 2/13/2006 Consumer France
Primary
Concomitant
Contusion Hospitalization 3/17/2004 53 Female 190 lb 12/27/2005 Consumer United States
Primary
Concomitant
Traumatic Intracranial Haemorrhage Death 10/1/2005 95 Male 12/27/2005 United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 7/1/2004 80 Male 190 lb 12/21/2005 Physician United States
Primary
Concomitant
Rectal Haemorrhage Hospitalization 12/9/2005 76 Female 183 lb 4/6/2006 Other Health Professional United Kingdom
Primary
Concomitant
Surgery Hospitalization 2/1/2003 55 Male 4/27/2006 Physician Norway
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization 7/16/2004 81 Female 4/28/2006 Norway
Primary
Concomitant
White Blood Cell Count Decreased Death 7/30/2005 66 Male 203 lb 5/3/2006 Other Health Professional Hungary
Primary
Secondary
Concomitant
Wound Infection Bacterial Other Serious 4/13/2006 69 Female 165 lb 5/5/2006 United States
Primary
Secondary
Concomitant
Interstitial Lung Disease Death 9/1/2005 73 Male 5/23/2006 Physician Japan
Primary
Secondary
Concomitant
Toxic Epidermal Necrolysis Death 4/8/2006 79 Female 6/15/2006 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 74 Female 6/29/2006 Consumer Japan
Primary
Secondary
Concomitant
Gallbladder Cancer Hospitalization 3/14/2006 Male 7/14/2006 Physician Japan
Primary
Concomitant
Cardiac Failure Congestive Hospitalization 10/21/2005 Female 88 lb 8/11/2006 Other Health Professional United States
Primary
Concomitant
Death Death 67 Female 162 lb 1/30/2006 Physician United States
Primary
Concomitant
Urinary Tract Infection Hospitalization 3/1/2006 Female 162 lb 10/27/2006 Physician United States
Primary
Concomitant
Duodenal Ulcer Haemorrhage Other Serious 8/30/2006 67 Male 10/25/2006 Japan
Primary
Concomitant
Melaena Other Serious 3/15/1999 72 Male 169 lb 11/17/2006 Consumer United States
Primary
Secondary
Concomitant
Sciatica Hospitalization 3/28/2006 75 Male 120 lb 11/27/2006 United States
Primary
Concomitant
Rhabdomyolysis Life Threatening 11/10/2006 78 Male 166 lb 12/1/2006 Pharmacist United States
Primary
Concomitant
Femur Fracture Other Serious 10/15/2005 Female 3/2/2007 Other Health Professional Sweden
Primary
Concomitant
Delirium Other Serious 3/13/2007 70 Male 169 lb 3/28/2007 Pharmacist United States
Primary
Concomitant
Renal Failure Chronic Hospitalization 10/21/2005 Female 88 lb 5/10/2007 Physician United States
Primary
Concomitant
Coronary Artery Occlusion Other Serious 1/1/2004 59 Male 205 lb 12/13/2006 Consumer United States
Primary
Concomitant
Contusion Hospitalization 8/7/2006 89 Female 123 lb 12/13/2006 Consumer United States
Primary
Concomitant
Granulocyte Count Increased Hospitalization 7/14/2007 64 Male 8/22/2007 Other Health Professional Denmark
Primary
Concomitant
Rhabdomyolysis Hospitalization 6/1/2005 42 Male 8/23/2007 Physician Spain
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 6/1/2005 42 Male 8/30/2007 Physician Spain
Primary
Secondary
Concomitant
Granulocyte Count Increased Hospitalization 7/14/2007 64 Male 8/31/2007 Other Health Professional Denmark
Primary
Concomitant
Iron Deficiency Other Serious 5/10/2004 8/31/2007 Other Health Professional Australia
Primary
Concomitant
Lichen Planus Other Serious 3/1/2007 68 Female 9/24/2007 Other Health Professional United Kingdom
Primary
Concomitant
Procedural Dizziness Other Serious 7/30/2007 76 Female 88 lb 9/27/2007 Physician Japan
Primary
Secondary
Concomitant
Incorrect Dose Administered Other Serious 7/30/2007 76 Female 88 lb 10/16/2007 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 11/25/2006 Female 103 lb 12/18/2007 Japan
Primary
Concomitant
Interacting
Hypoglycaemia Other Serious 11/25/2006 Female 103 lb 12/26/2007 Japan
Primary
Secondary
Concomitant
Interacting
Nutritional Condition Abnormal Other Serious 3/1/2008 65 Male 3/14/2008 Physician Japan
Primary
Secondary
Concomitant
Fatigue Other Serious 82 Female 124 lb 4/11/2008 Other Health Professional United States
Primary
Secondary
Concomitant
Sudden Death Death 3/26/2007 76 Female 108 lb 4/14/2008 Physician Japan
Primary
Concomitant
Sudden Death Death 3/26/2007 76 Female 108 lb 4/23/2008 Physician Japan
Primary
Concomitant
Lower Respiratory Tract Infection Hospitalization 88 Male 5/21/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Rhabdomyolysis Other Serious 6/1/2005 42 Male 5/23/2008 Physician Spain
Primary
Secondary
Concomitant
Renal Failure Other Serious 2/8/2008 Male 110 lb 5/23/2008 Physician Japan
Primary
Secondary
Concomitant
Interacting
Rhabdomyolysis Other Serious 6/1/2005 42 Male 6/3/2008 Physician Spain
Primary
Secondary
Concomitant
Heart Rate Increased Other Serious 5/28/2008 79 Male 6/12/2008 Consumer United States
Primary
Concomitant
Myocardial Infarction Other Serious 1/1/2004 Male 6/27/2008 Consumer
Primary
Concomitant
Coronary Artery Disease Hospitalization 6/5/2008 78 Male 154 lb 7/25/2008 Consumer Czech Republic
Primary
Concomitant
Vomiting Hospitalization 81 Male 9/29/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Vomiting Hospitalization 81 Male 10/2/2008 United Kingdom
Primary
Secondary
Hypertriglyceridaemia Other Serious 10/6/2008 70 Male 10/30/2008 Physician Japan
Primary
Concomitant
Hypertriglyceridaemia Other Serious 10/6/2008 70 Male 11/4/2008 Physician Japan
Primary
Concomitant
Hypertriglyceridaemia 10/6/2008 70 Male 11/11/2008 Physician Japan
Primary
Concomitant
Febrile Neutropenia Hospitalization 11/12/2008 Female 11/26/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Wheelchair User Hospitalization 3/1/2008 66 Female 245 lb 12/3/2008 Consumer United States
Primary
Concomitant
Cerebral Infarction Hospitalization 7/13/2008 85 Female 4/3/2009 Japan
Primary
Concomitant
Pulmonary Congestion Disability 1/1/2008 79 Female 165 lb 4/16/2009 Physician United States
Primary
Concomitant
Pulmonary Congestion Disability 1/1/2008 79 Female 165 lb 4/21/2009 Physician United States
Primary
Concomitant
Febrile Neutropenia Hospitalization 11/12/2008 Female 4/22/2009 Consumer United Kingdom
Primary
Secondary
Concomitant
Rash 3/2/2009 62 Male 130 lb 5/15/2009 Consumer United States
Primary
Concomitant
Temporal Arteritis Other Serious 1/1/2009 Female 102 lb 5/30/2009 Consumer United States
Primary
Concomitant
Road Traffic Accident Other Serious 5/12/2009 Male 179 lb 6/23/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cardiac Failure Acute Death 6/10/2009 Female 7/14/2009 Japan
Primary
Concomitant
Thrombocytopenia Other Serious 5/1/2009 Male 173 lb 7/14/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Myocardial Infarction Other Serious 35 Female 7/28/2009 Consumer United States
Primary
Secondary
Concomitant
Road Traffic Accident Other Serious 5/1/2009 Male 173 lb 8/25/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Cerebral Infarction Hospitalization 7/13/2008 85 Female 9/16/2009 Japan
Primary
Concomitant
Cardiac Failure Acute Death 6/10/2009 Female 11/30/2009 Japan
Primary
Concomitant
Temporal Arteritis Other Serious 1/1/2009 Female 102 lb 12/1/2009 Consumer United States
Primary
Concomitant
Torsade De Pointes Hospitalization 82 Male 165 lb 12/2/2009 Physician Japan
Primary
Secondary
Concomitant
Cardiac Failure Acute Death 6/11/2009 Female 12/21/2009 Japan
Primary
Concomitant
Cerebral Infarction Hospitalization 7/13/2009 85 Female 12/23/2009 Physician Japan
Primary
Concomitant
Torsade De Pointes Life Threatening 82 Male 165 lb 4/26/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Swollen Tongue Life Threatening 3/24/2010 86 Male 4/29/2010 United Kingdom
Primary
Concomitant
Dermatitis Exfoliative Other Serious 3/11/2010 5/12/2010 Consumer United Kingdom
Primary
Concomitant
Transient Ischaemic Attack Other Serious 1/9/2010 70 Female 5/21/2010 Physician Netherlands
Primary
Secondary
Concomitant
Nausea Other Serious 4/5/2010 76 Male 5/27/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 75 Male 5/24/2010 Netherlands
Primary
Secondary
Ventricular Arrhythmia Other Serious 75 Male 5/28/2010 Physician Netherlands
Primary
Interacting
Hyperglycaemia Hospitalization 5/1/2010 80 Male 6/4/2010 Physician Germany
Primary
Concomitant
Nausea Other Serious 4/5/2010 76 Male 6/4/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Other Serious 2/1/2008 61 Male 6/22/2010 Lawyer United States
Primary
Concomitant
Hyperglycaemia Other Serious 5/1/2010 80 Female 176 lb 6/23/2010 Physician Germany
Primary
Concomitant
Protein Urine Present Other Serious 5/1/2010 80 Female 176 lb 6/25/2010 Physician Germany
Primary
Concomitant
Nausea Other Serious 4/5/2010 76 Male 231 lb 7/1/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Vision Blurred Other Serious 1/4/2008 72 Male 7/13/2010 Lawyer United States
Primary
Secondary
Concomitant
Ventricular Tachycardia Life Threatening 82 Male 165 lb 8/9/2010 Other Health Professional Japan
Primary
Concomitant
Interacting
Vomiting Other Serious 2/1/2008 61 Male 187 lb 8/19/2010 Other Health Professional United States
Primary
Concomitant
Vision Blurred Other Serious 1/1/2008 72 Male 214 lb 9/13/2010 Other Health Professional United States
Primary
Secondary
Concomitant
Small Intestinal Haemorrhage Hospitalization 11/20/2008 72 Male 95 lb 10/14/2010 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 8/21/2010 85 Male 215 lb 10/27/2010 Physician United States
Primary
Concomitant
Pneumonia Hospitalization 8/21/2010 85 Male 215 lb 10/29/2010 Physician United States
Primary
Concomitant
Vision Blurred Other Serious 1/1/2008 72 Male 214 lb 11/8/2010 Lawyer United States
Primary
Secondary
Concomitant
Squamous Cell Carcinoma Hospitalization 8/21/2010 85 Male 215 lb 11/12/2010 Physician United States
Primary
Concomitant
Vomiting Other Serious 2/1/2008 61 Male 187 lb 11/18/2010 Other Health Professional United States
Primary
Concomitant
Weight Increased 8/29/2010 11/30/2010 Consumer United States
Primary
Concomitant
Ventricular Arrhythmia Other Serious 75 Male 12/6/2010 Physician Netherlands
Primary
Interacting
Loss Of Consciousness Hospitalization 8/1/2010 75 Male 12/3/2010 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Rash Generalised Other Serious 1/1/2008 72 Male 214 lb 1/27/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 1/1/2010 86 Female 209 lb 2/7/2011 Physician United States
Primary
Concomitant
Road Traffic Accident Death 2/20/2008 52 Male 228 lb 1/28/2011 Lawyer United States
Primary
Concomitant
Malaise Death 2/20/2008 52 Male 228 lb 3/4/2011 Consumer United States
Primary
Concomitant
Vomiting Life Threatening 1/11/2011 76 Male 3/9/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Malaise Death 2/20/2008 52 Male 228 lb 3/15/2011 Lawyer United States
Primary
Concomitant
Urticaria Other Serious 2/5/2010 50 Female 206 lb 3/29/2011 Physician United States
Primary
Concomitant
Respiratory Arrest Death 2/20/2008 52 Male 228 lb 3/23/2011 Lawyer United States
Primary
Concomitant
Vomiting Life Threatening 1/11/2011 76 Male 4/7/2011 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Neutropenia Hospitalization 12/1/2010 81 Male 4/15/2011 Physician Greece
Primary
Secondary
Concomitant
Fatigue Hospitalization 1/9/2011 81 Male 4/18/2011 Physician Greece
Primary
Secondary
Concomitant
Hepatitis Other Serious 4/14/2011 67 Male 5/13/2011 Other Health Professional United Kingdom
Primary
Concomitant
Liver Function Test Abnormal Other Serious 4/14/2011 67 Male 5/16/2011 Physician United Kingdom
Primary
Concomitant
Atrial Fibrillation Hospitalization 5/4/2011 79 Male 5/17/2011 Physician Israel
Primary
Concomitant
Muscle Spasms Other Serious 4/12/2011 60 Female 5/19/2011 Pharmacist Ireland
Primary
Secondary
Concomitant
Nausea Other Serious 4/5/2010 76 Male 231 lb 5/23/2011 Other Health Professional United States
Primary
Secondary
Concomitant
Disturbance In Attention Disability 1/1/2009 70 Female 181 lb 5/24/2011 Physician United States
Primary
Concomitant
Gastrointestinal Haemorrhage Hospitalization Male 6/8/2011 Consumer United States
Primary
Concomitant
Loss Of Consciousness Hospitalization 82 Male 6/8/2011 Other Health Professional Japan
Primary
Concomitant
Renal Failure Chronic Other Serious 11/1/2009 64 Male 230 lb 7/13/2011 Physician United States
Primary
Concomitant
Stasis Dermatitis Other Serious 9/1/2005 75 Male 227 lb 7/26/2011 Consumer United States
Primary
Concomitant
Angina Unstable Hospitalization 5/24/2011 54 Male 159 lb 7/26/2011 Greece
Primary
Concomitant
Abnormal Behaviour Hospitalization 67 Female 7/28/2011 Physician United States
Primary
Concomitant
Mean Cell Haemoglobin Decreased Hospitalization 7/4/2011 71 Female 110 lb 7/29/2011 Other Health Professional Hong Kong
Primary
Secondary
Concomitant
In-stent Coronary Artery Restenosis Hospitalization 10/1/2010 71 Male 115 lb 9/12/2011 Physician Japan
Primary
Concomitant
Muscle Strain Hospitalization 7/4/2011 71 Female 110 lb 8/29/2011 Other Health Professional Hong Kong
Primary
Secondary
Concomitant
Cardio-respiratory Arrest Death 9/2/2011 69 Female 159 lb 9/7/2011 Other Health Professional United States
Primary
Concomitant
Blood Creatinine Increased Other Serious 63 Female 216 lb 9/27/2011 Physician Brazil
Primary
Secondary
Concomitant
Haemoglobin Decreased Other Serious 63 Female 216 lb 9/27/2011 Physician Brazil
Primary
Secondary
Concomitant
Coronary Artery Disease Hospitalization Male 247 lb 10/31/2011 Consumer United States
Primary
Concomitant
Blood Uric Acid Abnormal Other Serious 11/8/2011 Consumer Brazil
Primary
Secondary
Concomitant
Product Quality Issue 5/3/2011 56 Male 6/1/2011 Other Health Professional United States
Primary
Concomitant
Pneumonia Hospitalization Male 141 lb 12/16/2011 Other Health Professional Brazil
Primary
Secondary
Concomitant
Goitre Other Serious 54 Male 12/18/2011 Physician United Kingdom
Primary
Concomitant
Coronary Artery Disease Other Serious 52 Female 1/5/2012 Consumer Brazil
Primary
Concomitant
Drug Ineffective Other Serious 11/18/2011 77 Female 1/18/2012 Physician Italy
Primary
Secondary
Concomitant
Oesophageal Ulcer Hospitalization 73 Female 119 lb 1/23/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Antinuclear Antibody Positive Hospitalization 8/1/2011 77 Male 1/23/2012 Other Health Professional
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/4/2011 74 Female 1/31/2012 Consumer Hong Kong
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 48 Female 196 lb 3/1/2012 Consumer United States
Primary
Secondary
Constipation Male 3/14/2012 Consumer United States
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 11/26/2009 80 Male 174 lb 3/15/2012 Physician Greece
Primary
Secondary
Concomitant
Hyponatraemia Hospitalization 11/26/2009 80 Male 174 lb 3/27/2012 Physician Greece
Primary
Secondary
Concomitant
Eyelid Oedema Other Serious 1/1/2010 71 Male 172 lb 4/12/2012 Other Health Professional Japan
Primary
Concomitant
Hypoglycaemic Unconsciousness Other Serious 9/25/2011 79 Male 5/18/2012 Physician United Kingdom
Primary
Concomitant
Angina Pectoris Other Serious 4/1/2011 78 Male 5/21/2012 Pharmacist Canada
Primary
Concomitant
Peritonitis Hospitalization 7/14/2010 73 Male 249 lb 5/21/2012 Other Health Professional United States
Primary
Secondary
Concomitant
Swelling Face Other Serious 3/29/2012 72 Female 155 lb 5/25/2012 Other Health Professional United Kingdom
Primary
Concomitant
White Blood Cell Count Decreased 5/1/2012 66 Male 175 lb 5/28/2012 Consumer United States
Primary
Concomitant

Drug Data