Novolin N combined with Novolin R

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Skin Test Positive Hospitalization 3/1/2005 70 Male 97 lb 1/9/2006 Physician Japan
Primary
Secondary
Concomitant
Drug Hypersensitivity Other Serious 11/4/2005 75 Male 165 lb 1/18/2006 Physician Japan
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 11/8/2005 67 Male 118 lb 1/30/2006 Physician Japan
Primary
Concomitant
Hepatic Function Abnormal Other Serious 1/1/2006 53 Female 90 lb 2/14/2006 Physician Japan
Primary
Secondary
Skin Cancer Other Serious Male 2/15/2006 Consumer United States
Primary
Concomitant
Perianal Abscess Other Serious 1/1/2006 53 Female 90 lb 2/24/2006 Physician Japan
Primary
Secondary
Concomitant
Perianal Abscess Other Serious 1/1/2006 53 Female 90 lb 3/9/2006 Physician Japan
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 9/24/2003 29 Female 4/24/2006 Physician Japan
Primary
Secondary
Concomitant
Glycosylated Haemoglobin Increased Other Serious 11/4/2005 75 Male 165 lb 5/1/2006 Physician Japan
Primary
Secondary
Concomitant
Hypoaesthesia Oral Hospitalization 38 Female 5/26/2006 Physician Japan
Primary
Concomitant
Hepatic Enzyme Increased Hospitalization 5/9/2006 46 Male 5/26/2006 Physician Japan
Primary
Secondary
Procedural Complication Hospitalization 5/11/2006 53 Male 5/25/2006 Japan
Primary
Secondary
Concomitant
Hypoaesthesia Oral Hospitalization 5/5/2006 39 Female 97 lb 6/7/2006 Physician Japan
Primary
Concomitant
Weight Decreased 2/13/2006 61 Male 320 lb 4/17/2006 Consumer United States
Primary
Concomitant
Swelling Face Life Threatening 5/5/2006 39 Female 97 lb 6/9/2006 Physician Japan
Primary
Concomitant
Vomiting Hospitalization 5/11/2005 52 Male 6/2/2006 Japan
Primary
Secondary
Concomitant
Hepatic Enzyme Increased Hospitalization 5/9/2006 46 Male 6/12/2006 Physician Japan
Primary
Secondary
Pyrexia Other Serious 11/1/2003 Female 197 lb 6/22/2006 Physician United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 5/1/2006 24 Female 101 lb 6/23/2006 Physician Japan
Primary
Secondary
Concomitant
Injection Site Swelling Hospitalization 5/5/2006 39 Female 97 lb 6/23/2006 Physician Japan
Primary
Concomitant
Weight Decreased 1/15/2006 44 Female 375 lb 4/17/2006 Consumer United States
Primary
Concomitant
Hypersensitivity Other Serious 3/1/2005 45 Female 280 lb 6/30/2006 United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 5/1/2006 24 Female 101 lb 6/30/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 11/1/2003 Female 197 lb 6/30/2006 Physician United States
Primary
Secondary
Concomitant
Weight Decreased 1/6/2006 65 Female 226 lb 4/17/2006 Consumer United States
Primary
Concomitant
Endocrine Test Abnormal Other Serious 4/3/2006 67 Male 7/14/2006 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased 3/22/2006 80 Male 218 lb 6/9/2006 Consumer United States
Primary
Concomitant
Hypoglycaemia Hospitalization 4/3/2006 67 Male 130 lb 8/1/2006 Physician Japan
Primary
Secondary
Concomitant
Vomiting Hospitalization 5/11/2006 52 Male 7/25/2006 Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Hospitalization 7/18/2006 60 Male 8/7/2006 Physician Japan
Primary
Secondary
Blood Glucose Fluctuation Hospitalization 4/3/2006 67 Male 130 lb 8/11/2006 Physician Japan
Primary
Secondary
Concomitant
Staphylococcal Bacteraemia Hospitalization 9/13/2002 53 Male 224 lb 8/8/2006 United States
Primary
Concomitant
Glycosylated Haemoglobin Increased Hospitalization 7/18/2006 60 Male 8/16/2006 Physician Japan
Primary
Secondary
Paraesthesia Other Serious Male 250 lb 7/19/2006 Consumer United States
Primary
Secondary
Concomitant
Hepatic Steatosis Hospitalization 7/18/2006 60 Male 8/29/2006 Physician Japan
Primary
Secondary
Pruritus Generalised 5/23/2006 65 Female 179 lb 7/24/2006 Pharmacist United States
Primary
Secondary
Concomitant
Penile Pain Hospitalization 51 Male 9/1/2006 United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 3/1/2006 84 Female 112 lb 9/21/2006 Physician Japan
Primary
Secondary
Concomitant
Injection Site Haemorrhage 5/26/2006 55 Male 389 lb 7/19/2006 Consumer United States
Primary
Concomitant
Weight Decreased 5/1/2006 73 Female 180 lb 7/19/2006 Consumer United States
Primary
Concomitant
Blood Glucose Fluctuation Hospitalization 3/1/2006 84 Female 112 lb 9/28/2006 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Fluctuation Hospitalization 3/1/2006 84 Female 112 lb 10/3/2006 Physician Japan
Primary
Secondary
Concomitant
Injection Site Pain Hospitalization 9/13/2006 68 Male 157 lb 10/5/2006 Physician Japan
Primary
Secondary
Concomitant
Stomach Discomfort Other Serious 1/1/2004 62 Female 218 lb 9/24/2006 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Required Intervention 6/1/2005 78 Male 232 lb 8/15/2006 Consumer United States
Primary
Secondary
Hypoglycaemic Coma Required Intervention 9/15/2005 45 Female 8/15/2006 Consumer United States
Primary
Concomitant
Blood Glucose Decreased Hospitalization 1/12/2006 65 Male 185 lb 8/15/2006 Consumer United States
Primary
Secondary
Concomitant
Hepatitis Fulminant Hospitalization 7/10/2006 40 Female 10/26/2006 Physician Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/1986 50 Female 11/2/2006 Consumer United States
Primary
Secondary
Concomitant
Drug Hypersensitivity Hospitalization 54 Male 139 lb 11/8/2006 Japan
Primary
Secondary
Concomitant
Diabetes Mellitus Inadequate Control Hospitalization 1/1/2006 64 Male 123 lb 11/8/2006 Physician Japan
Primary
Secondary
Concomitant
Injection Site Pain Hospitalization 9/13/2006 68 Male 157 lb 11/9/2006 Physician Japan
Primary
Secondary
Concomitant
Gastric Cancer Other Serious 5/1/2003 34 Female 108 lb 11/17/2006 Physician Japan
Primary
Secondary
Gastric Cancer Other Serious 1/1/2006 29 Female 104 lb 11/20/2006 Physician Japan
Primary
Secondary
Drug Hypersensitivity Hospitalization 8/12/2004 54 Male 139 lb 11/22/2006 Japan
Primary
Secondary
Liver Disorder Hospitalization 7/18/2006 60 Male 11/29/2006 Physician Japan
Primary
Secondary
Nephrogenic Diabetes Insipidus Hospitalization 10/1/2006 56 Female 137 lb 12/5/2006 Physician Japan
Primary
Concomitant
Drug Hypersensitivity Hospitalization 8/12/2004 54 Male 139 lb 12/6/2006 Japan
Primary
Secondary
Blood Glucose Fluctuation Hospitalization 3/1/2006 84 Female 112 lb 12/21/2006 Physician Japan
Primary
Secondary
Concomitant
Skin Test Positive Hospitalization 3/1/2005 70 Male 97 lb 12/22/2006 Physician Japan
Primary
Secondary
Concomitant
Glycosylated Haemoglobin Increased Hospitalization 3/1/2005 68 Male 143 lb 12/30/2006 Physician Japan
Primary
Secondary
Facial Palsy Hospitalization 1/20/2006 57 Male 168 lb 12/26/2006 Physician Japan
Primary
Concomitant
Drug Ineffective 1/1/2006 63 Male 380 lb 9/15/2006 Consumer United States
Primary
Concomitant
Drug Hypersensitivity Hospitalization 3/17/2005 78 Female 93 lb 1/23/2007 Japan
Primary
Secondary
Concomitant
Drug Hypersensitivity Other Serious 11/4/2005 75 Male 165 lb 1/23/2007 Physician Japan
Primary
Secondary
Concomitant
Wrong Drug Administered Other Serious 1/1/2000 91 Female 1/30/2007 Consumer United States
Primary
Secondary
Concomitant
Toxic Skin Eruption Hospitalization 12/19/2006 70 Female 128 lb 1/26/2007 Physician Japan
Primary
Secondary
Concomitant
Diabetes Mellitus Inadequate Control Hospitalization 1/1/2006 64 Male 123 lb 2/2/2007 Physician Japan
Primary
Secondary
Concomitant
Anti-insulin Antibody Positive Hospitalization 3/1/2005 68 Male 143 lb 2/13/2007 Physician Japan
Primary
Secondary
Nausea 7/25/2006 55 Male 412 lb 10/16/2006 Consumer United States
Primary
Concomitant
Lymphoedema Disability 3/16/2006 48 Female 128 lb 3/12/2007 Physician Japan
Primary
Secondary
Concomitant
Nephrogenic Diabetes Insipidus Hospitalization 10/1/2006 56 Female 137 lb 3/16/2007 Physician Japan
Primary
Concomitant
No Adverse Drug Effect 57 Male 168 lb 3/16/2007 Physician Japan
Primary
Secondary
Concomitant
Pneumonia Hospitalization 3/21/2007 Female 3/23/2007 Pharmacist United States
Primary
Concomitant
Haemolytic Anaemia Hospitalization 3/21/2007 Male 3/23/2007 Pharmacist United States
Primary
Concomitant
No Therapeutic Response 1/1/2005 68 Female 192 lb 1/23/2007 Consumer United States
Primary
Concomitant
Lymphoedema Other Serious 2/13/2006 48 Female 146 lb 4/10/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Increased 10/9/2006 65 Male 300 lb 1/12/2007 Consumer United States
Primary
Concomitant
Lymphoedema Other Serious 2/13/2006 48 Female 146 lb 4/17/2007 Physician Japan
Primary
Secondary
Concomitant
Aspartate Aminotransferase Increased Other Serious 5/30/2006 56 Female 115 lb 4/26/2007 Japan
Primary
Secondary
Blood Glucose Fluctuation Male 1/25/2007 Consumer United States
Primary
Secondary
Injection Site Pain Hospitalization 9/13/2006 68 Male 157 lb 6/5/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Fluctuation Hospitalization 6/20/2006 84 Female 112 lb 6/8/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Fluctuation Hospitalization 75 Male 6/11/2007 Physician Japan
Primary
Secondary
Blood Glucose Abnormal Hospitalization 73 Female 6/11/2007 Physician Japan
Primary
Secondary
Hepatic Function Abnormal Hospitalization 17 Female 6/11/2007 Physician Japan
Primary
Secondary
Injection Site Pain Hospitalization 9/13/2006 68 Male 157 lb 6/18/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Abnormal Hospitalization 8/1/2005 72 Female 90 lb 6/19/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Fluctuation Hospitalization 4/1/2003 Male 123 lb 6/19/2007 Physician Japan
Primary
Secondary
Concomitant
Nervousness 3/7/2007 71 Male 230 lb 4/10/2007 Consumer United States
Primary
Concomitant
Decreased Appetite 1/1/2007 70 Female 350 lb 4/10/2007 Consumer United States
Primary
Concomitant
Weight Decreased 12/1/2006 82 Male 195 lb 4/10/2007 Consumer United States
Primary
Concomitant
Toxic Skin Eruption Hospitalization 12/19/2006 70 Female 128 lb 6/21/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Abnormal Hospitalization 8/1/2005 72 Female 90 lb 6/27/2007 Physician Japan
Primary
Secondary
Concomitant
Blood Glucose Fluctuation Life Threatening 4/1/2003 Male 123 lb 6/27/2007 Physician Japan
Primary
Secondary
Concomitant
Skin Test Positive Hospitalization 3/1/2005 70 Male 97 lb 7/20/2007 Japan
Primary
Secondary
Concomitant
Nausea Other Serious 8/1/2006 65 Male 8/6/2007 Physician Japan
Primary
Secondary
Concomitant
Somnolence Other Serious 7/25/2007 60 Male 8/13/2007 Pharmacist Japan
Primary
Concomitant
Weight Decreased 1/1/2006 65 Male 283 lb 7/11/2007 Consumer United States
Primary
Concomitant
Dizziness 4/26/2007 57 Male 7/11/2007 Consumer United States
Primary
Concomitant
Hypertension 2/1/2007 55 Male 7/11/2007 Consumer United States
Primary
Concomitant
Weight Decreased Hospitalization 1/1/2005 38 Male 250 lb 7/11/2007 Consumer United States
Primary
Concomitant
Rash Hospitalization 7/24/2007 70 Female 143 lb 9/10/2007 Physician Japan
Primary
Secondary
Concomitant
Somnolence Other Serious 7/25/2007 60 Male 9/10/2007 Pharmacist Japan
Primary
Concomitant
Transient Ischaemic Attack Hospitalization 1/1/2004 Female 150 lb 9/10/2007 Physician United States
Primary
Concomitant
Glycosylated Haemoglobin Increased Other Serious 6/1/2007 55 Female 9/22/2007 Physician Japan
Primary
Concomitant
Glycosylated Haemoglobin Increased Other Serious 6/1/2007 55 Female 9/26/2007 Physician Japan
Primary
Concomitant
Rash Hospitalization 7/24/2007 70 Female 143 lb 9/27/2007 Physician Japan
Primary
Secondary
Concomitant
Hypersensitivity Hospitalization 10/1/2002 72 Male 203 lb 8/22/2007 Consumer United States
Primary
Concomitant
Blood Glucose Decreased Required Intervention 2/16/2007 59 Female 110 lb 8/22/2007 Consumer United States
Primary
Concomitant
Pain Other Serious 1/1/2007 Male 10/10/2007 Consumer Canada
Primary
Secondary
Concomitant
Vision Blurred Other Serious 9/22/2007 38 Male 150 lb 10/22/2007 Consumer United States
Primary
Concomitant
Panniculitis Hospitalization 9/13/2006 68 Male 157 lb 11/6/2007 Japan
Primary
Secondary
Concomitant
Insulin Autoimmune Syndrome Other Serious 86 Male 143 lb 11/6/2007 Physician Japan
Primary
Secondary
Hypoglycaemia Other Serious 86 Male 143 lb 11/15/2007 Japan
Primary
Secondary
Hepatic Function Abnormal Other Serious 10/18/2007 46 Male 75 lb 11/19/2007 Physician Japan
Primary
Secondary
Concomitant
Stomach Discomfort Other Serious 1/1/2002 Male 235 lb 11/20/2007 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 2/7/2007 78 Male 110 lb 11/21/2007 Japan
Primary
Secondary
Concomitant
Rash Other Serious 10/18/2007 Male 93 lb 11/30/2007 Physician Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious Male 132 lb 12/4/2007 Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 10/22/2007 46 Male 12/4/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 10/22/2007 46 Male 12/7/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Rash Other Serious 10/15/2007 Male 93 lb 12/11/2007 Physician Japan
Primary
Secondary
Concomitant
Nausea 4/26/2007 65 Male 10/9/2007 Consumer United States
Primary
Concomitant
Rash Other Serious 10/15/2007 Male 93 lb 12/19/2007 Physician Japan
Primary
Secondary
Concomitant
Eye Excision Other Serious 1/1/2007 Male 12/20/2007 Consumer United States
Primary
Concomitant
Protein Urine Present Hospitalization 33 Female 12/21/2007 Japan
Primary
Secondary
Concomitant
Rash Other Serious 10/15/2007 Male 93 lb 12/21/2007 Physician Japan
Primary
Secondary
Concomitant
Weight Decreased Hospitalization 1/1/2005 Female 194 lb 12/20/2007 Consumer United States
Primary
Concomitant
Small For Dates Baby Other Serious 4 lb 12/24/2007 Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 10/22/2007 46 Male 93 lb 12/31/2007 Pharmacist Japan
Primary
Secondary
Concomitant
Protein Urine Present Hospitalization 33 Female 1/2/2008 Japan
Primary
Secondary
Concomitant
Transient Ischaemic Attack Hospitalization 1/1/2004 Female 150 lb 1/2/2008 Physician United States
Primary
Concomitant
Hypoglycaemia Other Serious 7 Female 62 lb 1/3/2008 Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2007 Male 12/23/2007 Consumer Canada
Primary
Secondary
Concomitant
Hypoglycaemic Seizure Other Serious 7 Female 62 lb 1/15/2008 Japan
Primary
Secondary
Influenza Hospitalization 1/1/2007 1/15/2008 Consumer United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 1/1/2007 59 Female 1/11/2008 Consumer United States
Primary
Concomitant
Malaise Life Threatening 10/27/2007 51 Male 118 lb 1/16/2008 Physician Japan
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 7/1/2007 55 Male 11/8/2007 Consumer United States
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 7/1/2007 55 Male 11/8/2007 Consumer United States
Primary
Secondary
Concomitant
Chronic Obstructive Pulmonary Disease Death 12/23/2007 84 Female 1/23/2008 Consumer United States
Primary
Secondary
Concomitant
Liver Function Test Abnormal Other Serious 7/30/2007 40 Female 1/24/2008 Other Health Professional Japan
Primary
Concomitant
Pruritus Hospitalization 62 Female 1/30/2008 Consumer United States
Primary
Secondary
Concomitant
Weight Decreased Life Threatening 10/27/2007 51 Male 118 lb 2/7/2008 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Hospitalization 10/22/2007 46 Male 93 lb 2/13/2008 Pharmacist Japan
Primary
Secondary
Concomitant
Pneumonia Other Serious 10/4/2007 Male 2/5/2008 Pharmacist United States
Primary
Concomitant
Therapeutic Response Unexpected Other Serious 2/1/2005 66 Female 2/14/2008 Consumer United States
Primary
Concomitant
Diabetic Retinopathy 8/1/2007 72 Male 1/10/2008 Consumer United States
Primary
Concomitant
Polyneuropathy Hospitalization 3/1/2005 68 Male 143 lb 3/17/2008 Physician Japan
Primary
Secondary
Concomitant

Drug Data