Lantus combined with Opticlik (Insulin Injection Pen)

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Hyperglycaemia Hospitalization 9/1/2005 Male 105 lb 1/3/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 10/1/2005 Female 1/6/2006 Consumer United States
Primary
Secondary
Concomitant
Device Malfunction Other Serious 10/13/2005 58 Female 1/6/2006 Consumer United States
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 9/1/2005 Female 1/6/2006 Consumer United States
Primary
Secondary
Concomitant
Device Failure Other Serious 10/13/2005 58 Female 1/10/2006 Consumer United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 10/17/2005 Male 1/11/2006 Physician United States
Primary
Secondary
Concomitant
Medical Device Complication Other Serious 1/12/2006 United States
Primary
Secondary
Hyperglycaemia Hospitalization 9/1/2005 Male 105 lb 1/12/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 10/2/2005 Female 155 lb 1/12/2006 Consumer United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/30/2005 5 Male 1/13/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 9/1/2005 Female 1/13/2006 Consumer United States
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Other Serious 1/17/2006 United States
Primary
Secondary
Pharmaceutical Product Complaint Hospitalization 9/1/2005 Male 105 lb 1/19/2006 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 1/1/2006 77 Female 1/20/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Failure Other Serious 10/1/2005 Female 1/20/2006 Physician United States
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 6/1/2005 Male 185 lb 1/20/2006 Consumer United States
Primary
Secondary
Concomitant
Injection Site Pain Hospitalization 10/1/2005 Female 1/20/2006 United States
Primary
Secondary
Concomitant
Coronary Artery Stenosis Hospitalization 7/20/2005 60 Male 1/20/2006 Physician Japan
Primary
Secondary
Concomitant
Hepatic Function Abnormal Other Serious 56 Male 1/20/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 1/11/2006 Female 1/24/2006 Consumer United States
Primary
Secondary
Concomitant
Vision Blurred Other Serious 77 Male 150 lb 1/24/2006 Consumer United States
Primary
Secondary
Concomitant
Heart Rate Increased Other Serious 10/2/2005 Female 110 lb 1/24/2006 Consumer United States
Primary
Secondary
Concomitant
Overdose Other Serious 1/25/2006 United States
Primary
Secondary
Somnolence Other Serious 1/18/2006 Female 245 lb 1/30/2006 Consumer United States
Primary
Secondary
Concomitant
Lower Limb Fracture Other Serious 1/21/2006 Female 2/1/2006 Consumer United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Hospitalization 2/1/2005 Female 95 lb 2/6/2006 Consumer United States
Primary
Secondary
Concomitant
Generalised Oedema Hospitalization 1/1/2005 Female 216 lb 2/7/2006 Consumer United States
Primary
Secondary
Concomitant
Somnolence Other Serious 1/18/2006 Female 245 lb 2/9/2006 Consumer United States
Primary
Secondary
Concomitant
Adverse Drug Reaction Other Serious 2/10/2006 Pharmacist Japan
Primary
Secondary
Tremor Hospitalization 1/1/2005 Female 175 lb 2/10/2006 Consumer United States
Primary
Secondary
Concomitant
Pyrexia Other Serious 11/1/2005 54 Female 2/13/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 1/31/2006 Female 380 lb 2/15/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/30/2005 Male 44 lb 2/15/2006 Consumer United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 11/1/2005 68 Male 133 lb 2/16/2006 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 33 Male 2/17/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Illusion Other Serious 5/23/2005 29 Female 119 lb 2/17/2006 Physician Japan
Primary
Secondary
Concomitant
Pyrexia Other Serious 11/1/2005 54 Female 2/21/2006 Consumer United States
Primary
Secondary
Concomitant
Unevaluable Event Hospitalization 2/22/2006 Physician United States
Primary
Secondary
Pharmaceutical Product Complaint Hospitalization 1/31/2006 Female 380 lb 2/22/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Paraesthesia Hospitalization 1/1/2005 Female 175 lb 2/23/2006 Physician United States
Primary
Secondary
Concomitant
Suicide Attempt Other Serious 11/1/2005 62 Male 117 lb 2/24/2006 Physician Japan
Primary
Secondary
Concomitant
Urinary Tract Infection Hospitalization 2/1/2005 Female 95 lb 2/24/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Disorder Other Serious 2/1/2006 Male 201 lb 3/1/2006 Consumer United States
Primary
Secondary
Concomitant
No Adverse Effect Hospitalization 1/1/2006 Male 201 lb 3/1/2006 Consumer United States
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 7/19/2005 60 Female 3/1/2006 Consumer United States
Primary
Secondary
Concomitant
Fall Other Serious 3/2/2006 Physician Japan
Primary
Secondary
Ulcerative Keratitis Other Serious 1/1/2005 Female 190 lb 3/2/2006 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Life Threatening 1/16/2006 32 Male 110 lb 3/2/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization Female 3/3/2006 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemic Coma Life Threatening 1/16/2006 32 Male 110 lb 3/7/2006 Pharmacist Japan
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 2/26/2006 Female 3/7/2006 Consumer United States
Primary
Secondary
Weight Increased Other Serious 11/1/2005 Female 152 lb 3/9/2006 Consumer United States
Primary
Secondary
Concomitant
Lung Neoplasm Malignant Other Serious 11/1/2005 68 Male 133 lb 3/9/2006 Physician Japan
Primary
Secondary
Concomitant
Suicidal Ideation Other Serious 2/26/2006 Female 3/9/2006 Consumer United States
Primary
Secondary
Weight Increased Other Serious 11/1/2005 Female 152 lb 3/17/2006 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 10/4/2005 Female 3/20/2006 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious Female 3/21/2006 Physician Japan
Primary
Secondary
Triple Vessel Bypass Graft Hospitalization 8/1/2005 Female 170 lb 3/27/2006 Consumer United States
Primary
Secondary
Concomitant
Pollakiuria Other Serious Male 3/30/2006 Consumer Japan
Primary
Secondary
Concomitant
Weight Increased Other Serious 1/1/2006 Male 160 lb 3/31/2006 Consumer United States
Primary
Secondary
Concomitant
Liver Disorder Other Serious 66 Female 4/4/2006 Physician Japan
Primary
Secondary
Concomitant
Shoulder Pain Other Serious Male 4/5/2006 Consumer Japan
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization Female 183 lb 4/5/2006 Consumer United States
Primary
Secondary
Concomitant
No Adverse Effect Hospitalization 1/1/2006 Male 201 lb 4/6/2006 Physician United States
Primary
Secondary
Concomitant
Loss Of Consciousness Other Serious 1/1/2006 83 Male 145 lb 4/7/2006 Pharmacist United States
Primary
Secondary
Concomitant
Liver Disorder Other Serious 66 Female 4/7/2006 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization Female 4/10/2006 Consumer United States
Primary
Secondary
Pharmaceutical Product Complaint Other Serious 10/13/2005 58 Female 4/14/2006 Consumer United States
Primary
Secondary
Concomitant
Urinary Tract Obstruction Other Serious 9/1/2005 Male 4/19/2006 Consumer United States
Primary
Secondary
Concomitant
Sudden Hearing Loss Other Serious 25 Female 4/19/2006 Physician Japan
Primary
Secondary
Visual Acuity Reduced Other Serious 75 Female 4/20/2006 Consumer United States
Primary
Secondary
Concomitant
Memory Impairment Other Serious Female 80 lb 4/20/2006 Other Health Professional United States
Primary
Secondary
Liver Disorder Hospitalization 8/8/2005 29 Male 112 lb 4/21/2006 Physician Japan
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization Female 4/24/2006 Consumer United States
Primary
Secondary
Pituitary-dependent Cushing's Syndrome Other Serious 52 Female 4/24/2006 Consumer United States
Primary
Secondary
Concomitant
Memory Impairment Other Serious Female 80 lb 4/25/2006 Other Health Professional United States
Primary
Secondary
Pharmaceutical Product Complaint Hospitalization Female 183 lb 4/26/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 9/1/2005 Female 4/27/2006 Consumer United States
Primary
Secondary
Concomitant
Macular Degeneration Other Serious Male 4/27/2006 Consumer United States
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious Female 4/27/2006 Consumer United States
Primary
Secondary
Pharmaceutical Product Complaint Other Serious 4/28/2006 United States
Primary
Secondary
Weight Increased Other Serious 10/17/2005 Male 4/28/2006 Physician United States
Primary
Secondary
Concomitant
Staphylococcal Infection Hospitalization 10/1/2005 Male 4/28/2006 Consumer United States
Primary
Secondary
Concomitant
Sudden Hearing Loss Other Serious 25 Female 5/1/2006 Physician Japan
Primary
Secondary
Hyperglycaemia Hospitalization 1/1/2005 Female 216 lb 5/1/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Impairment Hospitalization 68 Male 100 lb 5/1/2006 Physician Japan
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 1/1/2005 75 Female 5/2/2006 Consumer United States
Primary
Secondary
Concomitant
Blood Glucose Increased Hospitalization 9/30/2005 Female 289 lb 5/3/2006 Consumer United States
Primary
Secondary
Concomitant
Pituitary-dependent Cushing's Syndrome Other Serious 52 Female 5/3/2006 Consumer United States
Primary
Secondary
Concomitant
Hypoglycaemia Other Serious 4/11/2006 64 Female 5/3/2006 Consumer
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 10/1/2005 Female 5/4/2006 United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious Female 130 lb 5/8/2006 Physician United States
Primary
Secondary
Concomitant
Lower Limb Fracture Other Serious 1/21/2006 Female 5/8/2006 Consumer United States
Primary
Secondary
Concomitant
Medical Device Complication Other Serious 2/1/2006 Male 175 lb 5/9/2006 Consumer United States
Primary
Secondary
Concomitant
Myocardial Infarction Hospitalization Female 183 lb 5/10/2006 Consumer United States
Primary
Secondary
Concomitant
Oedema Peripheral Hospitalization 1/31/2006 Female 380 lb 5/10/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Macular Degeneration Other Serious 5/1/2006 80 Female 177 lb 5/12/2006 Consumer United States
Primary
Secondary
Concomitant
Macular Degeneration Other Serious Male 165 lb 5/12/2006 Consumer United States
Primary
Secondary
Concomitant
Pneumonia Hospitalization 64 Male 5/16/2006 Consumer United States
Primary
Secondary
Concomitant
Visual Disturbance Other Serious 1/1/2006 Female 5/16/2006 Consumer United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious Female 130 lb 5/16/2006 Physician United States
Primary
Secondary
Concomitant
Vomiting Hospitalization 11/30/2005 Male 44 lb 5/16/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 5/1/2006 80 Female 177 lb 5/17/2006 Consumer United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Other Serious 4/6/2006 Female 5/17/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Surgery Other Serious 12/1/2005 Female 5/18/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious Male 165 lb 5/19/2006 Consumer United States
Primary
Secondary
Concomitant
Medical Device Complication Other Serious 2/1/2006 Male 175 lb 5/19/2006 Consumer United States
Primary
Secondary
Concomitant
Visual Field Defect Other Serious 4/6/2006 Female 5/19/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Haematuria Other Serious 5/12/2006 Male 5/19/2006 Consumer United Kingdom
Primary
Secondary
Hyperglycaemia Hospitalization 9/1/2005 Male 105 lb 5/25/2006 Consumer United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 1/1/2005 Female 6/1/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious Male 6/5/2006 Physician United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Hospitalization 6/1/2005 Female 196 lb 6/5/2006 United States
Primary
Secondary
Concomitant
Medical Device Complication Other Serious 79 Female 6/7/2006 Consumer United States
Primary
Secondary
Concomitant
Weight Decreased Other Serious 1/1/2005 84 Male 6/7/2006 Physician United States
Primary
Secondary
Concomitant
Visual Acuity Reduced Other Serious 1/1/2005 Female 6/7/2006 Other Health Professional United States
Primary
Secondary
Concomitant
Medical Device Complication Other Serious Male 165 lb 6/7/2006 Consumer United States
Primary
Secondary
Concomitant
Diabetic Retinopathy Other Serious 2/1/2006 Female 209 lb 6/7/2006 Consumer United States
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 5/25/2006 Female 6/9/2006 Consumer United States
Primary
Secondary
Concomitant
Weight Increased Other Serious 7/11/2005 Male 160 lb 6/12/2006 Physician United States
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Other Serious 6/12/2006 United States
Primary
Secondary
Retinitis Other Serious 1/1/2005 Female 6/12/2006 Consumer United States
Primary
Secondary
Concomitant
Memory Impairment Other Serious Female 80 lb 6/13/2006 Other Health Professional United States
Primary
Secondary
Visual Disturbance Other Serious 1/1/2006 Female 6/13/2006 Consumer United States
Primary
Secondary
Concomitant
Urine Ketone Body Present Hospitalization 2/23/2006 66 Female 6/14/2006 Physician Japan
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 1/1/2005 6/15/2006 Consumer United States
Primary
Secondary
Concomitant
Venous Stasis Other Serious 2/1/2006 82 Female 6/15/2006 Physician United States
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 5/25/2006 Female 6/16/2006 Consumer United States
Primary
Secondary
Concomitant
White Blood Cell Count Decreased Other Serious 2/1/2006 Male 175 lb 6/16/2006 Physician United States
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 1/1/2005 6/21/2006 Consumer United States
Primary
Secondary
Concomitant
Ketosis Hospitalization 6/13/2006 Female 6/23/2006 United States
Primary
Secondary
Concomitant
Hypoaesthesia Hospitalization 6/11/2006 Male 240 lb 6/26/2006 Consumer United States
Primary
Secondary
Concomitant
Somnolence Other Serious 1/18/2006 Female 245 lb 6/27/2006 Consumer United States
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 1/1/2005 Female 6/27/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 5/1/2006 80 Female 177 lb 6/27/2006 Consumer United States
Primary
Secondary
Concomitant
Gastritis Hospitalization Female 6/27/2006 Consumer United States
Primary
Secondary
Small For Dates Baby Other Serious 12/17/2004 Male 0 lb 6/28/2006 Physician Japan
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 1/1/2004 Male 6/29/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 5/25/2006 Female 6/30/2006 Consumer United States
Primary
Secondary
Concomitant
Upper Limb Fracture Other Serious 11/3/2005 Female 160 lb 6/30/2006 Consumer United States
Primary
Secondary
Concomitant
Wrong Technique In Drug Usage Process Other Serious 10/2/2005 Female 155 lb 7/5/2006 Physician United States
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 1/1/2005 Female 7/5/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 5/25/2006 Female 7/5/2006 Consumer United States
Primary
Secondary
Concomitant
Poor Quality Drug Administered Hospitalization 6/11/2006 Male 240 lb 7/6/2006 Consumer United States
Primary
Secondary
Concomitant
Renal Cell Carcinoma Stage Unspecified Hospitalization 2/1/2006 Female 7/10/2006 Consumer United States
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious Female 7/11/2006 Consumer United States
Primary
Secondary
Pleural Effusion Other Serious 1/1/2005 7/13/2006 Physician United States
Primary
Secondary
Concomitant
Treatment Noncompliance Other Serious 5/25/2006 Female 7/13/2006 Physician United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 10/2/2005 Female 110 lb 7/14/2006 Consumer United States
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint Other Serious 3/1/2006 Female 110 lb 7/17/2006 Consumer United States
Primary
Secondary
Concomitant

Drug Data