Irinotecan Hydrochloride combined with Leucovorin Calcium

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Hospitalization 4/11/2006 43 Female 148 lb 7/4/2006 Other Health Professional United Kingdom
Primary
Secondary
Depressed Level Of Consciousness Other Serious 8/6/2006 42 Male 9/20/2006 Other Health Professional Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/7/2007 52 Female 150 lb 12/27/2007 Canada
Primary
Concomitant
Neutropenia Other Serious 3/22/2006 Male 181 lb 3/17/2008 United Kingdom
Primary
Secondary
Interacting
Intestinal Obstruction Other Serious 8/17/2003 57 Male 4/9/2008 United States
Primary
Secondary
Oesophagitis Hospitalization 68 Male 4/18/2008 Physician United Kingdom
Primary
Concomitant
Interstitial Lung Disease Hospitalization 4/9/2008 Male 4/29/2008 Consumer United Kingdom
Primary
Concomitant
Reflux Oesophagitis Hospitalization 3/29/2008 Male 157 lb 4/30/2008 Physician United Kingdom
Primary
Concomitant
Colitis Hospitalization 8/31/2008 Male 170 lb 10/8/2008 Physician United States
Primary
Concomitant
Interstitial Lung Disease Other Serious 1/10/2007 Male 10/8/2008 Physician Australia
Primary
Concomitant
Rhabdomyolysis Hospitalization 9/1/2008 Male 10/10/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Keratoconjunctivitis Sicca Hospitalization 9/5/2008 68 Male 10/13/2008 Consumer Germany
Primary
Secondary
General Physical Health Deterioration Hospitalization 7/18/2007 Female 10/14/2008 Physician France
Primary
Secondary
Septic Shock Hospitalization 6/28/2007 Female 10/14/2008 Physician France
Primary
Secondary
Neutrophil Count Decreased Disability 11/22/2007 Female 98 lb 10/14/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Neuropathy Peripheral Hospitalization 4/2/2008 Male 134 lb 10/15/2008 Physician Japan
Primary
Secondary
Concomitant
Sepsis Life Threatening 7/11/2008 Male 10/17/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Hypersensitivity Other Serious 6/16/2008 Female 183 lb 10/20/2008 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Thrombosis Hospitalization 10/3/2008 Male 10/20/2008 Physician Sweden
Primary
Secondary
Concomitant
Laryngospasm Life Threatening 10/8/2008 Female 10/20/2008 Physician Austria
Primary
Secondary
Concomitant
Hypovolaemic Shock Life Threatening 10/5/2008 Female 10/21/2008 Physician Switzerland
Primary
Secondary
Hypovolaemic Shock Life Threatening 10/8/2008 Female 10/22/2008 Physician United Kingdom
Primary
Secondary
Restrictive Pulmonary Disease Other Serious 1/10/2007 Male 10/22/2008 Physician Australia
Primary
Concomitant
Anaphylactic Shock Other Serious 5/15/2008 Female 10/23/2008 Consumer Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/14/2008 70 Male 10/24/2008 Consumer Germany
Primary
Secondary
Weight Decreased Hospitalization 7/1/2008 Female 10/27/2008 Physician Germany
Primary
Secondary
Concomitant
Uterine Haemorrhage Other Serious 7/1/2008 40 Female 10/27/2008 Consumer Denmark
Primary
Secondary
Pulmonary Thrombosis Hospitalization 10/3/2008 Male 10/29/2008 Physician Sweden
Primary
Secondary
Concomitant
Abdominal Rigidity Other Serious 7/1/2008 Male 10/29/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Intestinal Obstruction Life Threatening 9/17/2008 Female 10/31/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Neutrophil Count Decreased Other Serious 1/11/2008 Male 106 lb 10/31/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Hypomagnesaemia Other Serious 5/13/2008 Male 185 lb 10/31/2008 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 10/14/2008 70 Male 11/4/2008 Consumer Germany
Primary
Secondary
Drug Eruption Hospitalization 6/16/2008 Female 11/4/2008 Consumer Japan
Primary
Secondary
Concomitant
Rectal Haemorrhage Other Serious 10/1/2008 45 Female 11/5/2008 Physician Russian Federation
Primary
Secondary
Concomitant
Intestinal Obstruction Hospitalization 10/4/2008 Female 90 lb 11/5/2008 Japan
Primary
Secondary
Concomitant
Hypovolaemic Shock Life Threatening 10/5/2008 65 Female 11/3/2008 Physician Switzerland
Primary
Secondary
Myocardial Infarction Death 10/30/2008 Female 104 lb 11/7/2008 Japan
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 9/10/2008 Female 11/10/2008 Physician United Kingdom
Primary
Concomitant
Disease Progression Death 5/8/2008 Female 157 lb 11/10/2008 Physician Japan
Primary
Secondary
Concomitant
Peptic Ulcer Disability 1/1/2008 Male 119 lb 11/10/2008 Consumer Japan
Primary
Secondary
Concomitant
Pulmonary Thrombosis Hospitalization 10/3/2008 Male 11/10/2008 Physician Sweden
Primary
Secondary
Concomitant
Hypomagnesaemia Other Serious 5/13/2008 Male 185 lb 11/11/2008 Physician United States
Primary
Secondary
Concomitant
Keratoconjunctivitis Sicca Hospitalization 9/5/2008 68 Male 11/11/2008 Consumer United States
Primary
Secondary
Pulmonary Infarction Life Threatening 10/22/2008 Female 121 lb 11/11/2008 Consumer United Kingdom
Primary
Concomitant
Hypovolaemic Shock Life Threatening 10/8/2008 Female 11/11/2008 Physician United Kingdom
Primary
Secondary
Herpes Zoster Hospitalization 11/29/2007 Female 105 lb 11/12/2008 Other Health Professional Japan
Primary
Secondary
Concomitant
Pleural Effusion Death 10/30/2008 Female 104 lb 11/13/2008 Japan
Primary
Secondary
Concomitant
Nephrotic Syndrome Other Serious 1/10/2008 Male 11/14/2008 Physician Japan
Primary
Concomitant
Hypersensitivity Other Serious 6/16/2008 Female 183 lb 11/18/2008 Physician Germany
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Hospitalization 9/26/2008 Female 11/18/2008 Physician United States
Primary
Concomitant
Anaemia Other Serious 11/19/2008 Physician United Kingdom
Primary
Secondary
Perinephric Collection Hospitalization 9/25/2007 Male 11/19/2008 Physician Australia
Primary
Concomitant
Vomiting Other Serious 10/11/2008 70 Male 11/20/2008 Consumer Germany
Primary
Secondary
Anaphylactic Shock Hospitalization 9/1/2008 Female 11/20/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Grand Mal Convulsion Hospitalization 9/10/2008 Female 11/20/2008 Physician United Kingdom
Primary
Concomitant
Lymphocyte Count Decreased Hospitalization 10/30/2008 43 Female 103 lb 11/18/2008 Physician United States
Primary
Secondary
Vitreous Haemorrhage Other Serious 8/4/2008 Male 11/21/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Myocardial Ischaemia Hospitalization 7/24/2008 69 Male 212 lb 11/21/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Renal Failure Acute Other Serious 10/5/2008 Female 11/24/2008 Physician Switzerland
Primary
Secondary
Pulmonary Embolism Life Threatening 10/8/2008 Female 11/25/2008 Physician United Kingdom
Primary
Secondary
Renal Failure Other Serious 10/14/2008 Male 11/25/2008 Physician United Kingdom
Primary
Secondary
Peritonitis Hospitalization 11/11/2008 Female 108 lb 11/25/2008 Physician United Kingdom
Primary
Concomitant
Hypokalaemia Other Serious 4/8/2008 Male 88 lb 11/25/2008 India
Primary
Secondary
Concomitant
C-reactive Protein Increased Hospitalization 9/29/2008 Male 11/26/2008 Consumer United States
Primary
Secondary
Pulmonary Thrombosis Hospitalization 10/4/2008 Male 11/26/2008 Physician Sweden
Primary
Secondary
Concomitant
Pyrexia Hospitalization 9/18/2008 Male 11/26/2008 Physician Austria
Primary
Concomitant
Myocardial Infarction Death 10/30/2008 Female 104 lb 11/28/2008 Japan
Primary
Secondary
Concomitant
Febrile Neutropenia Life Threatening 3/30/2006 Female 137 lb 11/30/2008 United Kingdom
Primary
Secondary
Concomitant
Red Blood Cell Count Decreased Hospitalization 10/30/2008 43 Female 103 lb 11/21/2008 Physician United States
Primary
Secondary
Pulmonary Embolism Other Serious 7/9/2008 Female 12/5/2008 Physician Germany
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 7/1/2008 Female 12/5/2008 Physician Germany
Primary
Secondary
Concomitant
Pulmonary Embolism Hospitalization 9/14/2008 Female 12/5/2008 Physician Germany
Primary
Concomitant
Laryngospasm Life Threatening 10/8/2008 Female 12/5/2008 Physician Austria
Primary
Secondary
Concomitant
Abdominal Rigidity Other Serious 7/1/2008 Male 12/10/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Platelet Count Decreased Hospitalization 11/25/2008 Male 146 lb 12/10/2008 Physician Japan
Primary
Secondary
Concomitant
Keratoconjunctivitis Sicca Hospitalization 9/5/2008 68 Male 12/12/2008 Consumer United States
Primary
Secondary
Sudden Death Death 10/31/2008 67 Male 12/15/2008 Physician Japan
Primary
Secondary
Pulmonary Thrombosis Hospitalization 10/4/2008 Male 12/15/2008 Physician Sweden
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/6/2008 Male 12/15/2008 Physician Germany
Primary
Secondary
Interstitial Lung Disease Hospitalization 11/1/2008 71 Male 12/15/2008 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 1/15/2008 Female 12/17/2008 Physician United Kingdom
Primary
Concomitant
Tumour Lysis Syndrome Hospitalization 6/4/2008 12/19/2008 Other Health Professional Ukraine
Primary
Secondary
Concomitant
Anaphylactic Shock Hospitalization 9/1/2008 Female 12/23/2008 Consumer United Kingdom
Primary
Secondary
Concomitant
Stomatitis Hospitalization 10/27/2008 Female 128 lb 12/30/2008 Physician Japan
Primary
Secondary
Concomitant
White Blood Cell Count Abnormal Other Serious 8/4/2008 Male 12/31/2008 Consumer Japan
Primary
Secondary
Concomitant
Ileus Hospitalization 12/17/2008 Male 1/15/2009 Physician Germany
Primary
Secondary
Concomitant
Anal Inflammation Hospitalization 12/17/2008 Male 141 lb 1/16/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Haematemesis Hospitalization 3/21/2006 59 Male 2/27/2009 Physician France
Primary
Secondary
Concomitant
Acute Myocardial Infarction Hospitalization 2/22/2008 3/9/2009 Physician Korea, Republic Of
Primary
Secondary
Concomitant
Vomiting Death 10/14/2008 47 Male 82 lb 3/12/2009 Other Health Professional Israel
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Other Serious 65 Female 4/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 43 Male 4/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Other Serious 56 Female 4/30/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Acute Promyelocytic Leukaemia Other Serious 65 Female 4/30/2009 Other Health Professional Turkey
Primary
Secondary
Concomitant
Chronic Myeloid Leukaemia Hospitalization 1/1/2008 66 Male 4/30/2009 Other Health Professional Turkey
Primary
Secondary
Concomitant
Retroperitoneal Abscess Life Threatening 5/16/2008 4/30/2009 Physician Poland
Primary
Secondary
Sepsis Hospitalization 7/30/2008 5/4/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Pyrexia Life Threatening 12/28/2007 Male 165 lb 5/4/2009 Physician Japan
Primary
Secondary
Concomitant
Tumour Lysis Syndrome Hospitalization 6/4/2008 5/6/2009 Other Health Professional Ukraine
Primary
Secondary
Concomitant
Sepsis Hospitalization 7/30/2008 63 5/14/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/5/2008 28 5/21/2009 Physician India
Primary
Secondary
Concomitant
Retroperitoneal Abscess Life Threatening 5/16/2008 66 5/22/2009 Physician Poland
Primary
Secondary
Sepsis Hospitalization 7/30/2008 63 6/5/2009 Other Health Professional Australia
Primary
Secondary
Concomitant
Vomiting Hospitalization 7/5/2008 28 6/10/2009 Physician India
Primary
Secondary
Concomitant
Vomiting Hospitalization 4/22/2007 51 Male 6/11/2009 Consumer United States
Primary
Secondary
Dysarthria Hospitalization 6/23/2009 75 Male 342 lb 7/7/2009 Other Health Professional United States
Primary
Concomitant
Subclavian Vein Thrombosis Life Threatening 9/30/2009 62 Male 196 lb 10/9/2009 Other Health Professional United States
Primary
Secondary
Concomitant
Ataxia Hospitalization 10/6/2009 Female 159 lb 2/16/2010 Physician United States
Primary
Secondary
Pyrexia Hospitalization 5/31/2008 54 Male 202 lb 3/29/2010 Physician South Africa
Primary
Secondary
Concomitant
Stomatitis Other Serious 1/12/2010 59 Male 4/12/2010 Physician Japan
Primary
Secondary
Concomitant
Pulmonary Embolism Other Serious 7/8/2009 71 Male 139 lb 4/13/2010 Physician Japan
Primary
Concomitant
Venous Thrombosis Other Serious 9/22/2008 59 Male 152 lb 4/15/2010 Physician Japan
Primary
Concomitant
Lymphangiosis Carcinomatosa Other Serious Male 4/28/2010 Physician Japan
Primary
Secondary
Sepsis Death 1/15/2010 51 Male 5/4/2010 Physician United States
Primary
Secondary
Visual Acuity Reduced Other Serious 12/16/2008 57 Male 172 lb 5/6/2010 Physician Germany
Primary
Concomitant
Colitis Ulcerative Hospitalization 4/15/2009 66 Male 5/7/2010 Physician Germany
Primary
Concomitant
Pulmonary Embolism Hospitalization 12/24/2008 48 Female 121 lb 5/27/2010 Other Health Professional Japan
Primary
Secondary
Hydronephrosis Other Serious 1/1/2009 56 Male 5/28/2010 Other Health Professional Japan
Primary
Concomitant
Small Intestinal Perforation Other Serious 11/1/2008 60 Male 119 lb 6/8/2010 Physician Japan
Primary
Secondary
Concomitant
Hepatic Neoplasm Malignant Other Serious 80 Male 6/8/2010 Japan
Primary
Concomitant
Urinary Tract Infection Other Serious 6/1/2009 70 Female 104 lb 6/18/2010 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 55 Male 6/18/2010 Physician Japan
Primary
Concomitant
Malaise Hospitalization 6/25/2010 65 Female 8/4/2010 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment Other Serious 7/29/2010 Female 8/9/2010 Physician Japan
Primary
Concomitant
Ventricular Fibrillation Other Serious 1/1/2009 62 Male 148 lb 8/11/2010 Physician Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 6/4/2010 65 Female 8/19/2010 Physician Japan
Primary
Secondary
Concomitant
Visual Impairment 7/29/2010 Male 8/19/2010 Physician Japan
Primary
Concomitant
Left Ventricular Dysfunction Hospitalization 51 Male 8/23/2010 Other Health Professional Albania
Primary
Secondary
Enterobacter Sepsis Hospitalization 8/28/2007 57 Male 136 lb 8/25/2010 Other Health Professional United States
Primary
Secondary
Large Intestine Perforation Life Threatening 1/1/2010 81 Female 71 lb 8/30/2010 Physician Japan
Primary
Secondary
Concomitant
Large Intestine Perforation Life Threatening 1/1/2010 81 Female 71 lb 9/2/2010 Physician Japan
Primary
Secondary
Concomitant
Vesical Fistula Other Serious 8/7/2010 60 Female 9/20/2010 Pharmacist Japan
Primary
Secondary
Concomitant
Malaise Hospitalization 6/4/2010 65 Female 9/21/2010 Physician Japan
Primary
Secondary
Concomitant
Small Intestine Ulcer Other Serious 7/28/2010 55 Male 115 lb 9/24/2010 Physician Japan
Primary
Concomitant
White Blood Cell Count Decreased Other Serious 1/1/2009 54 Male 165 lb 10/6/2010 Physician Japan
Primary
Secondary
Concomitant
Oesophagitis Other Serious Male 10/11/2010 Pharmacist Canada
Primary
Secondary
Peptic Ulcer Other Serious 7/31/2010 60 Female 88 lb 10/13/2010 Physician Japan
Primary
Secondary
Concomitant
Stomatitis Other Serious 11/18/2009 56 Female 139 lb 10/13/2010 Physician United States
Primary
Concomitant
Stomatitis Life Threatening 7/6/2010 10/21/2010 Other Health Professional Japan
Primary
Secondary
Concomitant
Varicose Vein Other Serious 1/1/2008 69 Female 115 lb 10/22/2010 Physician Japan
Primary
Concomitant
Hyperammonaemia Hospitalization 6/14/2010 60 Female 10/29/2010 Physician Japan
Primary
Secondary
Concomitant
Wound Abscess Other Serious 1/1/2009 73 Female 11/9/2010 Physician Japan
Primary
Secondary
Concomitant
Malignant Hypertension Hospitalization 4/11/2009 69 Female 12/16/2010 Consumer United States
Primary
Secondary
Urinary Tract Infection Other Serious 1/1/2010 69 Female 12/17/2010 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Other Serious 1/1/2010 69 Female 1/4/2011 Physician Japan
Primary
Secondary
Concomitant
Urinary Retention Hospitalization 6/28/2010 1/12/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Diarrhoea Hospitalization 1/1/2010 69 Female 1/13/2011 Other Health Professional Japan
Primary
Secondary
Concomitant
Abdominal Infection Other Serious 1/1/2010 69 Female 1/20/2011 Physician Japan
Primary
Secondary
Concomitant
Ascites Other Serious 1/1/2010 Male 1/27/2011 Pharmacist Canada
Primary
Secondary

Drug Data