Itorol combined with Sigmart

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Cerebral Infarction Hospitalization 5/31/2006 74 Female 111 lb 1/18/2007 Physician Japan
Primary
Concomitant
Rash Other Serious 3/22/2005 74 Female 110 lb 1/24/2007 Physician Japan
Primary
Concomitant
Atrioventricular Block Complete Hospitalization 10/21/2006 Male 104 lb 2/20/2007 Physician Japan
Primary
Concomitant
Hyperthyroidism Hospitalization 10/1/2006 62 Male 2/28/2007 Physician France
Primary
Concomitant
Pneumonia Other Serious 2/13/2007 Male 3/21/2007 Other Health Professional Japan
Primary
Concomitant
Arrhythmia Other Serious 2/16/2007 55 Male 3/20/2007 Pharmacist Japan
Primary
Concomitant
Arrhythmia Other Serious 2/16/2007 55 Male 194 lb 3/28/2007 Pharmacist Japan
Primary
Concomitant
Palpitations 2/16/2007 55 Male 194 lb 4/16/2007 Pharmacist Japan
Primary
Concomitant
Weight Increased Other Serious 4/18/2007 86 Male 5/17/2007 Physician Japan
Primary
Concomitant
Weight Increased Other Serious 4/18/2007 86 Male 150 lb 5/29/2007 Physician Japan
Primary
Concomitant
Dysstasia Other Serious 4/1/2007 Female 6/8/2007 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 5/14/2007 79 Male 101 lb 6/14/2007 Physician Japan
Primary
Secondary
Concomitant
Dysstasia Other Serious 4/1/2007 Female 6/14/2007 Physician Japan
Primary
Concomitant
Interacting
Subdural Haematoma Hospitalization 5/21/2007 62 Male 134 lb 6/14/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 5/21/2007 62 Male 134 lb 6/20/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Hospitalization 5/14/2007 79 Male 101 lb 6/22/2007 Physician Japan
Primary
Secondary
Concomitant
Subdural Haematoma Hospitalization 5/21/2007 62 Male 134 lb 6/22/2007 Other Health Professional Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 1/16/2007 81 Female 8/16/2007 Japan
Primary
Secondary
Concomitant
Hepatitis Other Serious 1/16/2007 81 Female 10/29/2007 Japan
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 10/19/2007 83 Female 10/30/2007 Physician Japan
Primary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 10/25/2007 Physician Japan
Primary
Concomitant
Generalised Oedema Hospitalization 10/19/2007 83 Female 11/12/2007 Physician Japan
Primary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 11/22/2007 Physician Japan
Primary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 12/6/2007 Physician Japan
Primary
Concomitant
Toxic Epidermal Necrolysis Hospitalization 10/13/2007 Female 12/24/2007 Other Health Professional Japan
Primary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 12/26/2007 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 2/10/2004 81 Male 157 lb 1/15/2008 Physician Japan
Primary
Concomitant
Rash Other Serious 3/22/2005 74 Female 110 lb 1/22/2008 Physician Japan
Primary
Concomitant
Nervous System Disorder Hospitalization 1/15/2008 66 Male 154 lb 1/29/2008 Physician Japan
Primary
Concomitant
Renal Disorder Life Threatening 12/1/2007 74 Male 117 lb 2/15/2008 Physician Japan
Primary
Secondary
Concomitant
Nervous System Disorder Hospitalization 1/15/2008 66 Male 154 lb 2/20/2008 Physician Japan
Primary
Concomitant
Nervous System Disorder Hospitalization 1/15/2008 66 Male 154 lb 2/27/2008 Physician Japan
Primary
Concomitant
Ventricular Extrasystoles Other Serious 9/16/2007 40 Male 190 lb 2/28/2008 Physician Japan
Primary
Secondary
Concomitant
Renal Infarct Hospitalization 5/24/2007 60 Male 3/24/2008 Consumer Japan
Primary
Secondary
Concomitant
Osteitis Other Serious 2/20/2008 86 Female 4/7/2008 Other Health Professional Japan
Primary
Concomitant
Ventricular Extrasystoles Other Serious 9/16/2007 40 Male 190 lb 4/11/2008 Physician Japan
Primary
Secondary
Concomitant
Osteitis Other Serious 2/20/2008 85 Female 4/22/2008 Physician Japan
Primary
Concomitant
Cardiac Failure Life Threatening 11/5/2007 83 Female 122 lb 4/24/2008 Physician Japan
Primary
Secondary
Concomitant
Condition Aggravated Life Threatening 11/1/2007 Female 4/25/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Hallucination Other Serious 1/23/2008 68 Male 5/5/2008 Other Health Professional Japan
Primary
Concomitant
Schizophrenia Other Serious 1/23/2008 68 Male 5/7/2008 Other Health Professional Japan
Primary
Concomitant
Condition Aggravated Life Threatening 11/4/2007 Female 5/30/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Prothrombin Time Prolonged Other Serious 4/23/2008 81 Female 6/20/2008 Pharmacist Japan
Primary
Concomitant
Interacting
Sepsis Other Serious 1/1/2007 Male 160 lb 6/26/2008 Japan
Primary
Concomitant
Condition Aggravated Life Threatening 11/4/2007 Female 7/3/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 6/18/2008 79 Male 112 lb 8/4/2008 Physician Japan
Primary
Concomitant
Rhabdomyolysis Hospitalization 7/1/2008 81 Female 8/11/2008 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/8/2008 Female 8/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/8/2008 Female 8/14/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/3/2008 Female 8/21/2008 Physician Japan
Primary
Secondary
Concomitant
Prothrombin Time Prolonged 4/23/2008 Female 8/27/2008 Pharmacist Japan
Primary
Concomitant
Interacting
Rhabdomyolysis Hospitalization 7/1/2008 81 Female 8/28/2008 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/3/2008 Female 9/16/2008 Physician
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 9/12/2008 Physician Japan
Primary
Secondary
Concomitant
Enterocolitis Hospitalization 4/16/2007 85 Female 93 lb 9/18/2008 Physician Japan
Primary
Concomitant
Rhabdomyolysis Death 9/4/2008 82 Male 95 lb 9/19/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 9/4/2008 82 Male 95 lb 9/22/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/3/2008 Female 9/29/2008 Physician Japan
Primary
Secondary
Concomitant
Urine Output Decreased Hospitalization 9/1/2008 82 Male 10/2/2008 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 10/6/2008 Physician Japan
Primary
Concomitant
Rhabdomyolysis Death 9/4/2008 82 Male 95 lb 10/14/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Thrombosis In Device Life Threatening 9/16/2008 79 Male 123 lb 10/20/2008 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 9/4/2008 82 Male 95 lb 10/20/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Injection Site Induration Hospitalization 5/25/2007 68 Male 10/22/2008 Physician Japan
Primary
Concomitant
Urine Output Decreased Hospitalization 9/1/2008 82 Male 10/22/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Other Serious 1/1/2007 Male 160 lb 10/22/2008
Primary
Concomitant
Thrombosis In Device Life Threatening 9/16/2008 79 Male 123 lb 10/24/2008 Physician Japan
Primary
Secondary
Concomitant
Ventricular Extrasystoles Other Serious 9/16/2007 Male 190 lb 11/18/2008 Physician Japan
Primary
Secondary
Concomitant
Cerebral Haemorrhage Life Threatening 4/9/2008 55 Male 132 lb 11/24/2008 Other Health Professional Japan
Primary
Concomitant
Pancytopenia Life Threatening 9/1/2008 75 Male 12/1/2008 Physician Japan
Primary
Secondary
Ventricular Extrasystoles Other Serious 9/16/2007 Male 190 lb 11/28/2008 Physician Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/3/2008 Female 12/8/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Rhabdomyolysis Hospitalization 7/3/2008 Female 12/8/2008 Physician Japan
Primary
Secondary
Concomitant
Pancytopenia Other Serious 9/22/2008 70 Male 12/12/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombosis In Device Life Threatening 9/16/2008 79 Male 123 lb 12/18/2008 Physician Japan
Primary
Secondary
Concomitant
Thrombosis In Device Life Threatening 9/16/2008 79 Male 123 lb 12/24/2008 Physician Japan
Primary
Secondary
Concomitant
Enterocolitis Hospitalization 4/16/2007 85 Female 93 lb 12/29/2008 Physician Japan
Primary
Concomitant
Ventricular Fibrillation Other Serious 10/14/2008 Male 95 lb 12/31/2008 Physician Japan
Primary
Secondary
Concomitant
Posture Abnormal Other Serious 5/8/2008 80 Female 12/31/2008
Primary
Concomitant
Enterocolitis Hospitalization 4/16/2007 86 Female 93 lb 1/20/2009 Other Health Professional Japan
Primary
Concomitant
Prostate Cancer Death 5/28/2006 58 Male 2/2/2009 Japan
Primary
Concomitant
Renal Impairment Hospitalization 6/18/2008 79 Male 112 lb 2/6/2009 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 4/9/2008 55 Male 132 lb 2/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Posture Abnormal Other Serious 5/8/2008 Female 2/12/2009
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 1/1/2007 54 Male 132 lb 2/23/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Prostate Cancer Death 5/28/2006 58 Male 2/23/2009 Japan
Primary
Concomitant
Renal Impairment Hospitalization 2/5/2009 81 Male 163 lb 2/24/2009 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 1/13/2009 75 Male 123 lb 2/25/2009 Other Health Professional Germany
Primary
Concomitant
Dyspnoea Hospitalization 12/23/2008 Female 121 lb 3/9/2009 Physician Japan
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 11/21/2007 54 Male 132 lb 3/9/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 2/5/2009 82 Male 163 lb 3/12/2009 Physician Japan
Primary
Concomitant
Renal Impairment Hospitalization 2/5/2009 81 Male 163 lb 3/17/2009 Other Health Professional Japan
Primary
Concomitant
Cerebral Haemorrhage Life Threatening 11/21/2007 54 Male 132 lb 3/25/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Life Threatening 1/13/2009 75 Male 123 lb 3/27/2009 Other Health Professional Germany
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 6/18/2008 79 Male 112 lb 3/30/2009 Physician Japan
Primary
Concomitant
Blood Pressure Decreased Hospitalization 8/6/2008 Female 121 lb 4/6/2009 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 3/5/2009 Female 101 lb 4/9/2009 Physician Japan
Primary
Concomitant
Somnolence Hospitalization 3/5/2009 Female 101 lb 4/28/2009 Pharmacist Japan
Primary
Concomitant
Hepatitis Cholestatic Death 5/18/2009 71 Male 6/19/2009 Physician Japan
Primary
Secondary
Concomitant
Jaundice Cholestatic Death 5/15/2009 Male 148 lb 6/26/2009 Physician Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 5/1/2009 Male 148 lb 7/5/2009 Physician Japan
Primary
Secondary
Concomitant
In-stent Arterial Restenosis Hospitalization 2/21/2009 72 Male 7/13/2009 Physician Japan
Primary
Secondary
Concomitant
Ventricular Tachycardia Other Serious 5/1/2009 Male 148 lb 7/20/2009 Physician Japan
Primary
Secondary
Concomitant
Syncope Life Threatening 5/3/2009 Female 94 lb 8/24/2009 Physician Japan
Primary
Concomitant
Hypoglycaemia Other Serious 9/24/2008 Male 9/4/2009 Other Health Professional Japan
Primary
Concomitant
Renal Failure Acute Other Serious 8/21/2009 80 Female 9/9/2009 Physician Japan
Primary
Concomitant
Ventricular Extrasystoles Other Serious 9/16/2007 Male 190 lb 9/10/2009 Physician Japan
Primary
Secondary
Concomitant
Renal Failure Life Threatening 4/30/2009 Male 128 lb 10/5/2009 Other Health Professional Japan
Primary
Secondary
Concomitant
Malignant Neoplasm Progression Other Serious 1/1/2009 Female 153 lb 11/5/2009 Physician Japan
Primary
Secondary
Concomitant
Ventricular Extrasystoles Other Serious 9/16/2007 Male 190 lb 11/12/2009 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 1/1/2007 Male 11/30/2009 Physician Japan
Primary
Concomitant
Intracardiac Thrombus Other Serious Male 12/8/2009 Physician Japan
Primary
Concomitant
Renal Failure Life Threatening 4/30/2009 81 Male 128 lb 12/8/2009 Physician Japan
Primary
Secondary
Concomitant
Status Asthmaticus Hospitalization 10/2/2009 Male 12/10/2009 Pharmacist Japan
Primary
Concomitant
Cardiac Failure Death Male 12/21/2009 Japan
Primary
Concomitant
Status Asthmaticus Hospitalization 10/2/2009 Male 12/23/2009 Pharmacist Japan
Primary
Concomitant
Tumour Lysis Syndrome Hospitalization 8/20/2009 80 Female 75 lb 12/28/2009 Physician Japan
Primary
Concomitant
Syncope Life Threatening 11/20/2009 Female 88 lb 12/30/2009 Pharmacist Japan
Primary
Secondary
Concomitant
Status Asthmaticus Hospitalization 10/2/2009 Male 99 lb 1/4/2010 Pharmacist Japan
Primary
Concomitant
Status Asthmaticus Other Serious 10/2/2009 Male 99 lb 1/15/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Syncope Life Threatening 11/20/2009 Female 88 lb 1/18/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Condition Aggravated Life Threatening 4/10/2009 73 Female 2/2/2010 Other Health Professional France
Primary
Concomitant
Intracardiac Thrombus Other Serious 1/23/2009 50 Male 154 lb 2/9/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Life Threatening 1/13/2009 75 Male 123 lb 2/10/2010 Other Health Professional Germany
Primary
Secondary
Concomitant
Cardiac Failure Death 4/17/2007 82 Male 2/15/2010 Japan
Primary
Concomitant
Renal Impairment Hospitalization 7/29/2009 79 Male 121 lb 2/17/2010 Physician Japan
Primary
Concomitant
Cardiac Arrest Life Threatening 8/1/2009 78 Male 203 lb 2/23/2010 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 9/24/2008 Male 2/24/2010 Other Health Professional Japan
Primary
Concomitant
Liver Disorder Other Serious 8/20/2009 81 Male 115 lb 3/1/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 9/1/2008 75 Male 3/2/2010 Physician Japan
Primary
Secondary
White Blood Cell Count Decreased Other Serious 8/20/2009 81 Male 115 lb 3/4/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Rash Papular Other Serious 4/1/2009 Male 3/5/2010 Physician Japan
Primary
Concomitant
Liver Disorder Other Serious 8/20/2009 81 Male 115 lb 3/5/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Cardiac Failure Death 4/17/2007 82 Male 3/8/2010 Japan
Primary
Concomitant
Pneumonia Viral Other Serious 8/20/2009 81 Male 115 lb 3/8/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Cardiac Arrest Life Threatening 8/1/2009 78 Male 203 lb 3/11/2010 Physician Japan
Primary
Secondary
Concomitant
Chromaturia Other Serious 2/25/2010 74 Female 3/26/2010 Pharmacist Japan
Primary
Concomitant
Rash Papular Other Serious 4/1/2009 Male 3/29/2010 Physician Japan
Primary
Concomitant
Wolff-parkinson-white Syndrome Death 3/26/2010 85 Male 5/26/2010 Physician Japan
Primary
Concomitant
Condition Aggravated Hospitalization 4/10/2009 73 Female 6/17/2010 Other Health Professional France
Primary
Concomitant
Interstitial Lung Disease Life Threatening 1/15/2010 63 Male 6/24/2010 Other Health Professional Japan
Primary
Concomitant
Acute Myocardial Infarction Death 7/5/2010 74 Female 117 lb 7/15/2010 Physician Japan
Primary
Secondary
Concomitant
Pemphigus Hospitalization 9/10/2008 75 Male 132 lb 8/8/2010 Physician Japan
Primary
Secondary
Concomitant
Rash Papular Other Serious 4/1/2009 52 Male 9/13/2010 Other Health Professional Japan
Primary
Concomitant
Sweat Discolouration Hospitalization 81 Male 9/23/2010 Pharmacist Japan
Primary
Concomitant
Viral Rash Other Serious 4/1/2009 52 Male 9/24/2010 Other Health Professional Japan
Primary
Concomitant
Cardiac Disorder Death 3/11/2009 78 Male 10/29/2010 Other Health Professional Japan
Primary
Concomitant
Cardiac Disorder Death 3/11/2009 78 Male 108 lb 11/9/2010 Other Health Professional Japan
Primary
Concomitant
Cardiac Disorder Death 3/11/2009 78 Male 108 lb 11/12/2010 Other Health Professional Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 10/6/2010 80 Male 11/18/2010 Other Health Professional Japan
Primary
Concomitant

Drug Data