Levemir combined with Novorapid

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Vomiting Other Serious 6/16/2005 53 Female 132 lb 1/12/2006 Physician Turkey
Primary
Concomitant
Hypoglycaemia Hospitalization 10/24/2005 54 Male 141 lb 1/27/2006 Physician United Kingdom
Primary
Concomitant
Hypoglycaemia Other Serious 12/15/2004 25 Female 132 lb 2/7/2006 Physician Germany
Primary
Concomitant
Tremor Other Serious 12/6/2004 25 Female 132 lb 2/7/2006 Physician Germany
Primary
Concomitant
Tremor Other Serious 12/27/2004 25 Female 132 lb 2/7/2006 Physician Germany
Primary
Concomitant
Hypoglycaemia Other Serious 12/4/2004 25 Female 132 lb 2/7/2006 Physician Germany
Primary
Concomitant
Tremor Other Serious 12/22/2004 25 Female 132 lb 2/7/2006 Physician Germany
Primary
Concomitant
Scar Hospitalization 6/22/2005 26 Female 3/17/2006 Other Health Professional Denmark
Primary
Concomitant
Paraesthesia Other Serious 3/13/2006 36 Female 214 lb 3/22/2006 Consumer United Kingdom
Primary
Concomitant
Injection Site Vesicles Other Serious 2/21/2006 3/24/2006 Physician France
Primary
Secondary
Oedema Peripheral Other Serious 2/17/2006 38 Male 3/31/2006 Physician Canada
Primary
Concomitant
Swelling Face Other Serious 3/22/2006 48 Female 204 lb 4/13/2006 Other Health Professional United Kingdom
Primary
Concomitant
Oedema Peripheral Other Serious 2/17/2006 38 Male 205 lb 4/18/2006 Physician Canada
Primary
Concomitant
Hypoglycaemia Hospitalization 10/24/2005 54 Male 141 lb 4/26/2006 Physician United Kingdom
Primary
Concomitant
Injection Site Swelling Other Serious 37 Female 5/1/2006 Other Health Professional Canada
Primary
Concomitant
Cardiac Failure Congestive Other Serious 2/17/2006 38 Male 205 lb 5/11/2006 Physician Canada
Primary
Concomitant
Visual Disturbance Other Serious 4/26/2006 20 Male 5/16/2006 Other Health Professional Canada
Primary
Concomitant
Injection Site Vesicles Other Serious 2/21/2006 Male 220 lb 6/2/2006 Physician France
Primary
Concomitant
Suicide Attempt Life Threatening 5/29/2006 39 Male 6/7/2006 Physician Latvia
Primary
Concomitant
Diabetes Mellitus Other Serious 10/1/2005 15 Female 6/15/2006 Consumer Netherlands
Primary
Secondary
Concomitant
Injection Site Vesicles Other Serious 2/21/2006 Male 220 lb 7/18/2006 Physician France
Primary
Secondary
Concomitant
Dyspnoea Other Serious 4/25/2005 61 Female 132 lb 7/18/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Paraesthesia Other Serious 3/1/2006 36 Female 214 lb 8/7/2006 Physician United Kingdom
Primary
Concomitant
Syncope Vasovagal Hospitalization 7/10/2005 63 Female 234 lb 9/15/2006 Other Health Professional United Kingdom
Primary
Concomitant
Hypoglycaemia Hospitalization 10/24/2005 54 Male 141 lb 9/21/2006 Physician United Kingdom
Primary
Concomitant
Syncope Vasovagal Hospitalization 7/9/2005 63 Female 234 lb 10/9/2006 Other Health Professional United Kingdom
Primary
Concomitant
Pyrexia Other Serious 9/28/2006 57 Male 194 lb 10/11/2006 Physician Hungary
Primary
Concomitant
Urticaria Hospitalization 4/1/2006 11 Male 10/26/2006 Other Health Professional France
Primary
Secondary
Retinal Haemorrhage Disability 6/15/2006 26 Male 11/6/2006 France
Primary
Concomitant
Tension Headache Other Serious 10/27/2006 Female 11/15/2006 Consumer United Kingdom
Primary
Secondary
Concomitant
Orthostatic Hypotension Hospitalization 8/15/2006 Male 141 lb 11/27/2006 Physician United Kingdom
Primary
Concomitant
Retinal Haemorrhage Disability 6/15/2006 26 Male 11/20/2006 Other Health Professional France
Primary
Concomitant
Suicide Attempt Life Threatening 12/1/2006 143 lb 12/5/2006 Other Health Professional United Kingdom
Primary
Secondary
Hyperglycaemia Hospitalization 10/7/2006 Female 156 lb 12/6/2006 Physician United Kingdom
Primary
Secondary
Pyrexia Other Serious 9/28/2006 57 Male 194 lb 12/8/2006 Physician Hungary
Primary
Concomitant
Pregnancy Hospitalization 11/14/2006 17 Female 12/8/2006 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Tryptase Increased Life Threatening 10/10/2006 73 Female 176 lb 12/9/2006 France
Primary
Secondary
Concomitant
Alopecia Other Serious 8/15/2006 Female 137 lb 12/15/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 10/31/2006 49 Female 12/18/2006 Physician Canada
Primary
Concomitant
Loss Of Consciousness Hospitalization 9/24/2006 Female 194 lb 12/20/2006 Physician United Kingdom
Primary
Secondary
Concomitant
Foetal Distress Syndrome Other Serious 11/7/2006 Male 8 lb 12/22/2006 Physician
Primary
Concomitant
Pregnancy Hospitalization 11/14/2006 Female 12/27/2006 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Otorrhoea Hospitalization 7/9/2005 Female 234 lb 12/29/2006 Physician United Kingdom
Primary
Concomitant
Hyperkalaemia Hospitalization 11/30/2006 79 Male 12/29/2006 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Accident Death 4/25/2006 47 Male 1/2/2007 Consumer Brazil
Primary
Secondary
Pyrexia Other Serious 9/28/2006 57 Male 194 lb 1/4/2007 Physician Hungary
Primary
Concomitant
Hyperkalaemia Hospitalization 11/30/2006 79 Male 1/9/2007 Other Health Professional United Kingdom
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 10/31/2006 49 Female 1/11/2007 Physician Canada
Primary
Concomitant
Foetal Distress Syndrome Other Serious 11/7/2006 Male 8 lb 1/23/2007 Physician United Kingdom
Primary
Secondary
Viral Infection Hospitalization 10/7/2006 Female 156 lb 1/23/2007 Physician United Kingdom
Primary
Secondary
Loss Of Consciousness Hospitalization 9/24/2006 Female 194 lb 1/23/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Foetal Distress Syndrome Other Serious 11/7/2006 Male 8 lb 2/2/2007 Physician United Kingdom
Primary
Secondary
Otorrhoea Hospitalization 7/7/2005 Female 234 lb 2/2/2007 Physician United Kingdom
Primary
Concomitant
Pain In Extremity Other Serious 10/31/2006 49 Female 2/7/2007 Physician Canada
Primary
Concomitant
Femoral Neck Fracture Hospitalization 9/24/2006 Female 194 lb 2/8/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Pain In Extremity Disability 8/1/2006 Female 125 lb 2/8/2007 Other Health Professional United Kingdom
Primary
Concomitant
Rash Generalised Other Serious 1/22/2007 Female 236 lb 2/16/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Foetal Distress Syndrome Other Serious 11/7/2006 Male 8 lb 2/21/2007 Physician United Kingdom
Primary
Secondary
Retinal Haemorrhage Disability 6/15/2006 26 Male 123 lb 2/15/2007 Other Health Professional France
Primary
Concomitant
Weight Decreased Other Serious 11 132 lb 3/5/2007 Other Health Professional United Kingdom
Primary
Concomitant
Pain Life Threatening 10/3/2006 35 Female 187 lb 3/6/2007 Other Health Professional United Kingdom
Primary
Concomitant
Nausea Hospitalization Female 3/15/2007 Consumer United Kingdom
Primary
Secondary
Injection Site Swelling Other Serious 50 Male 203 lb 3/21/2007 Other Health Professional Norway
Primary
Concomitant
Diabetic Ketoacidosis Other Serious 2/9/2007 Male 92 lb 3/23/2007 Consumer United Kingdom
Primary
Concomitant
Vasculitis Death Female 3/26/2007 Physician Turkey
Primary
Secondary
Weight Decreased Other Serious 11 Male 132 lb 4/9/2007 Physician United Kingdom
Primary
Concomitant
Renal Failure Acute Death 73 Female 155 lb 4/9/2007 Physician Turkey
Primary
Secondary
Concomitant
Pregnancy Hospitalization 11/14/2006 Female 4/16/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Rash Generalised Other Serious 1/22/2007 Female 236 lb 5/1/2007 Consumer United Kingdom
Primary
Secondary
Concomitant
Rash Generalised Other Serious 1/22/2007 Female 236 lb 5/7/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Throat Irritation Other Serious 2/12/2007 44 Female 140 lb 4/30/2007 Physician United Kingdom
Primary
Concomitant
Diabetic Ketoacidosis Other Serious 2/9/2007 Male 92 lb 5/11/2007 Consumer United Kingdom
Primary
Concomitant
Skin Ulcer Hospitalization 4/30/2007 Female 5/16/2007 Consumer Australia
Primary
Secondary
Renal Failure Acute Hospitalization 73 Female 155 lb 5/16/2007 Physician Turkey
Primary
Secondary
Concomitant
Hypoaesthesia Other Serious 2/19/2007 59 Female 262 lb 5/25/2007 Other Health Professional United Kingdom
Primary
Concomitant
Injection Site Swelling Other Serious 1/1/2005 50 Male 203 lb 6/1/2007 Other Health Professional Norway
Primary
Concomitant
Injection Site Swelling Other Serious 1/1/2005 50 Male 203 lb 6/1/2007 Other Health Professional Norway
Primary
Concomitant
Vomiting Hospitalization 2/14/2007 35 Female 172 lb 6/5/2007 France
Primary
Secondary
Concomitant
Renal Failure Acute Hospitalization 73 Female 155 lb 6/26/2007 Physician Turkey
Primary
Secondary
Concomitant
Psychiatric Symptom Other Serious 9 Male 58 lb 7/9/2007 Other Health Professional United Kingdom
Primary
Concomitant
Tendonitis Other Serious 1/28/2007 62 Male 7/19/2007 Physician France
Primary
Concomitant
Renal Failure Acute Hospitalization 7/30/2007 Physician Turkey
Primary
Secondary
Concomitant
Vaginal Candidiasis Other Serious 5/15/2007 Female 119 lb 8/6/2007 Physician Estonia
Primary
Secondary
Concomitant
Macrosomia Other Serious 6/11/2007 Female 10 lb 8/6/2007 Physician Estonia
Primary
Secondary
Concomitant
Cholangitis Hospitalization 7/9/2007 35 Female 121 lb 8/1/2007 Consumer Germany
Primary
Secondary
Concomitant
Vitreous Haemorrhage Other Serious 12/27/2006 76 Female 148 lb 8/23/2007 Other Health Professional United Kingdom
Primary
Concomitant
Escherichia Infection Hospitalization 7/9/2007 35 Female 121 lb 8/22/2007 Consumer Germany
Primary
Secondary
Concomitant
Hyperglycaemia Other Serious 4/1/2007 9 Female 84 lb 9/4/2007 Other Health Professional United Kingdom
Primary
Concomitant
Vaginal Candidiasis Other Serious 5/15/2007 Female 119 lb 9/12/2007 Physician Estonia
Primary
Secondary
Concomitant
Pharmaceutical Product Complaint 12 Female 9/13/2007 Physician Canada
Primary
Concomitant
Small For Dates Baby Congenital Anomaly 1/19/2007 Female 4 lb 9/25/2007 Other Health Professional United Kingdom
Primary
Secondary
Shift To The Left Hospitalization 6/24/2007 35 Female 121 lb 9/20/2007 Other Health Professional Germany
Primary
Secondary
Concomitant
Oedema Other Serious Male 192 lb 9/27/2007 Physician Germany
Primary
Concomitant
Malaise Other Serious 5/21/2007 Female 10/1/2007 Physician United Kingdom
Primary
Secondary
Concomitant
Hypoglycaemia Hospitalization 1/1/2000 40 Female 10/5/2007 Consumer Germany
Primary
Concomitant
Intra-uterine Death Other Serious 12/22/2006 Female 10/12/2007 Physician Norway
Primary
Concomitant
Oedema Other Serious 2/1/2005 Male 192 lb 10/19/2007 Physician Germany
Primary
Concomitant
Vaginal Candidiasis Other Serious 4/23/2007 Female 119 lb 10/23/2007 Physician Estonia
Primary
Secondary
Concomitant
Abortion Spontaneous Other Serious 10/10/2007 Female 119 lb 10/23/2007 Physician Czech Republic
Primary
Secondary
Macrosomia Other Serious 6/11/2007 Female 10 lb 10/23/2007 Physician Estonia
Primary
Secondary
Concomitant
Paraesthesia Hospitalization Female 10/29/2007 Other Health Professional United Kingdom
Primary
Secondary
Head Injury Hospitalization 3/24/2007 Female 112 lb 10/31/2007 Physician United Kingdom
Primary
Secondary
Intentional Overdose Life Threatening 10/23/2007 29 Female 10/31/2007 Physician Bulgaria
Primary
Concomitant
Vitreous Floaters Other Serious 5/23/2007 Male 11/6/2007 Consumer United Kingdom
Primary
Concomitant
Abortion Spontaneous Other Serious 10/10/2007 Female 119 lb 11/13/2007 Physician Czech Republic
Primary
Secondary
Small For Dates Baby Other Serious 1/19/2007 Female 4 lb 11/15/2007 Other Health Professional United Kingdom
Primary
Secondary
Abortion Induced Other Serious 27 Female 11/16/2007 Physician Spain
Primary
Concomitant
Abortion Spontaneous Other Serious 28 Female 11/19/2007 Physician Spain
Primary
Concomitant
Congenital Anomaly Congenital Anomaly 11/19/2007 Physician Spain
Primary
Concomitant
Paraesthesia Life Threatening 10/13/2007 57 Female 165 lb 11/26/2007 Other Health Professional United Kingdom
Primary
Secondary
Abortion Induced Other Serious 12/27/2006 27 Female 11/29/2007 Physician Spain
Primary
Concomitant
Premature Labour Death 9/12/2007 Female 12/4/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Secondary
Foetal Malformation Death 12/5/2007 Physician Spain
Primary
Concomitant
Vaginal Haemorrhage Other Serious 9/12/2007 Female 123 lb 12/10/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Concomitant
Spina Bifida Other Serious 8/23/2007 Male 9 lb 12/11/2007 Physician Croatia (Local Name: Hrvatska)
Primary
Secondary
Suicide Attempt Life Threatening 10/23/2007 29 Female 12/19/2007 Physician Bulgaria
Primary
Concomitant
Syncope Hospitalization 10/7/2006 Female 156 lb 12/20/2007 Physician United Kingdom
Primary
Secondary
Foetal Malformation Death 12/21/2007 Physician Spain
Primary
Concomitant
Vomiting Hospitalization 1/1/2007 64 Male 12/31/2007 Other Health Professional Sweden
Primary
Secondary
Concomitant
Throat Cancer Other Serious 10/26/2007 60 Male 289 lb 1/18/2008 United Kingdom
Primary
Secondary
Concomitant
Foetal Malformation Death 1/21/2008 Physician Spain
Primary
Concomitant
Face Oedema Other Serious 12/20/2000 61 Male 190 lb 1/31/2008 Physician Estonia
Primary
Concomitant
Face Oedema Other Serious 12/20/2007 61 Male 190 lb 2/6/2008 Physician Estonia
Primary
Concomitant
Throat Cancer Other Serious 10/26/2007 60 Male 289 lb 2/19/2008 Physician United Kingdom
Primary
Concomitant
Malaise Other Serious 5/21/2007 Female 2/26/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Viral Infection Hospitalization 10/5/2006 Female 156 lb 2/29/2008 Physician United Kingdom
Primary
Secondary
Hydrocephalus Death 5/21/2007 2/26/2008 Physician United Kingdom
Primary
Secondary
Concomitant
Hypoglycaemic Coma Hospitalization 1/1/2008 41 Male 146 lb 2/29/2008 Physician Belgium
Primary
Secondary
Viral Infection Hospitalization 10/5/2006 Female 156 lb 3/5/2008 Physician United Kingdom
Primary
Secondary
Upper Respiratory Tract Infection Hospitalization 1/1/2008 41 Male 146 lb 3/5/2008 Physician Belgium
Primary
Secondary
Skin Ulcer Other Serious 2/1/2007 Female 216 lb 3/11/2008 Other Health Professional Australia
Primary
Secondary
Concomitant
Polyhydramnios Hospitalization 12/1/2007 Female 117 lb 3/17/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Small For Dates Baby Other Serious Male 4 lb 3/17/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Liver Disorder Hospitalization 3/3/2008 59 Male 3/15/2008 Physician Japan
Primary
Concomitant
Polyneuropathy Hospitalization 6/24/2007 35 Female 121 lb 9/20/2007 Physician Germany
Primary
Secondary
Concomitant
Polyhydramnios Hospitalization 12/14/2007 Female 117 lb 4/18/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Small For Dates Baby Other Serious 2/26/2008 Male 4 lb 4/18/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Injection Site Urticaria Hospitalization 4/1/2006 11 Male 4/24/2008 Other Health Professional France
Primary
Secondary
Small For Dates Baby Other Serious 2/26/2008 Male 4 lb 4/25/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Polyhydramnios Hospitalization 12/14/2007 Female 117 lb 4/30/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Pain In Extremity Other Serious 8/1/2006 Female 125 lb 5/9/2008 Other Health Professional United Kingdom
Primary
Concomitant
Hallucination, Visual Hospitalization 3/27/2008 39 Male 149 lb 5/9/2008 Consumer United Kingdom
Primary
Concomitant
Hypotension Other Serious 3/14/2008 80 Male 198 lb 5/6/2008 Physician Israel
Primary
Concomitant
Polyhydramnios Hospitalization 12/14/2007 Female 117 lb 5/12/2008 Physician Czech Republic
Primary
Secondary
Concomitant
Diabetic Ketoacidosis Other Serious 1/21/2008 Female 221 lb 5/12/2008 Physician United Kingdom
Primary
Concomitant
Loss Of Consciousness Other Serious Female 5/19/2008 Consumer United Kingdom
Primary
Secondary
Renal Impairment Other Serious 3/1/2007 45 Male 5/23/2008 Consumer Canada
Primary
Secondary
Concomitant
Pulmonary Congestion Other Serious 10/15/2007 Female 170 lb 5/27/2008 Consumer Switzerland
Primary
Concomitant
Renal Impairment Other Serious 3/1/2007 45 Male 5/28/2008 Consumer Canada
Primary
Secondary
Concomitant
Hypoglycaemic Unconsciousness Other Serious Female 6/3/2008 Consumer United Kingdom
Primary
Secondary

Drug Data