This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Levemir (Insulin Detemir Subcutaneous) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (316)
Death (17)
Life Threatening Events (10)
Disability (5)
Reports by Reaction Type
Blood Glucose Increased (62),
Hypoglycaemia (21),
Blood Glucose Decreased (17),
Dyspnoea (12),
Maternal Exposure During Pregnancy (12),
Drug Ineffective (10),
Dizziness (10),
Diabetes Mellitus Inadequate Control (10),
Dehydration (10),
Rash (9),
Convulsion (9),
Foetal Exposure During Pregnancy (8)
Below are a few examples of reports where side effects / adverse reactions may be related to Levemir (Insulin Detemir Subcutaneous). For a complete list or a specific selection of reports, please use the links above.
Possible Levemir side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 57 year old female, weighing 109.8 kg (241.5 pounds)
Reactions: Blood Glucose Increased, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humalog
Dosage: 30 u, qd
Indication: Diabetes Mellitus
Start date: 2012-01-01
Levemir
Dosage: 30 u, qd
Indication: Diabetes Mellitus
Start date: 2012-01-01
Other drugs received by patient: Diovan; Amlodipine Besylate; Lipitor
Possible Levemir side effects in female
Reported by a consumer/non-health professional from South Africa on 2012-08-24
Patient: female, weighing 2.5 kg (5.5 pounds)
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 25 u, qd
Start date: 2011-03-11
Levemir
Dosage: 25 u, qd
Indication: Diabetes Mellitus
Start date: 2011-03-11
Novorapid Flexpen
Dosage: 51 u, qd
Indication: Diabetes Mellitus
Start date: 2011-03-11
Possible Levemir side effects in 56 year old male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 56 year old male
Reactions: Malaise, Skin Discolouration, Oedema Peripheral, Cardiac Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 33 year old female
Reported by a physician from South Africa on 2012-08-22
Patient: 33 year old female, weighing 74.0 kg (162.8 pounds)
Reactions: Nausea, Pain, Maternal Exposure During Pregnancy, Diabetes Mellitus Inadequate Control
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 25 u, qd
Indication: Diabetes Mellitus
Start date: 2011-03-11
Novorapid Flexpen
Dosage: 51 u, qd
Indication: Diabetes Mellitus
Start date: 2011-03-11
Possible Levemir side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 50 year old female
Reactions: Myocardial Infarction
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 78 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 78 year old female, weighing 113.4 kg (249.4 pounds)
Reactions: Cerebrovascular Accident, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Lisinopril; Ezetimibe; Estrogen; Albuterol; Nitrofurantoin; Levothyroxine Sodium
Possible Levemir side effects in
Reported by a physician from Australia on 2012-08-21
Patient:
Reactions: Foetal Exposure During Pregnancy, Heart Disease Congenital
Adverse event resulted in: death
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 67 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 67 year old female, weighing 117.9 kg (259.4 pounds)
Reactions: Pulmonary Embolism, Deep Vein Thrombosis
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 76 year old female
Reported by a physician from United States on 2012-08-20
Patient: 76 year old female
Reactions: Pancreatic Carcinoma non-Resectable
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Humalog
Possible Levemir side effects in 37 year old female
Reported by a physician from South Africa on 2012-08-20
Patient: 37 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Foetal Distress Syndrome, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Levemir
Dosage: 8 u, qd
Indication: Gestational Diabetes
Start date: 2012-01-04
End date: 2012-01-25
Novorapid Flexpen
Dosage: 18 u, qd
Indication: Gestational Diabetes
Start date: 2012-01-04
End date: 2012-01-25
Possible Levemir side effects in 39 year old male
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-17
Patient: 39 year old male
Reactions: Blood Glucose Increased, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 90 iu, qd
Indication: Product Used FOR Unknown Indication
Levemir
Dosage: 40 iu, unk
Start date: 2012-07-26
Victoza
Victoza
Dosage: unk
Indication: Product Used FOR Unknown Indication
End date: 2012-07-30
Other drugs received by patient: Glyburide
Possible Levemir side effects in 72 year old female
Reported by a consumer/non-health professional from United States on 2012-08-16
Patient: 72 year old female, weighing 59.0 kg (129.7 pounds)
Reactions: Myalgia, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 20 u, qd
Indication: Type 2 Diabetes Mellitus
Start date: 2011-01-01
End date: 2012-08-03
Levemir
Dosage: 20 u, qd
Start date: 2012-08-05
Novolog
Dosage: 30-35 u per day
Indication: Type 2 Diabetes Mellitus
Start date: 2012-06-01
End date: 2012-08-03
Novolog
Dosage: 30-35 u per day
Start date: 2012-08-05
Other drugs received by patient: Glyburide
Possible Levemir side effects in
Reported by a physician from Japan on 2012-08-14
Patient:
Reactions: Drug Eruption, Atrial Fibrillation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Calblock
Dosage: 16 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2009-02-19
End date: 2011-11-03
Crestor
Dosage: 2.5 mg, qd
Administration route: Oral
Start date: 2011-12-01
Crestor
Dosage: 2.5 mg, qd
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2008-05-14
End date: 2011-11-03
Crestor
Dosage: unk
Januvia
Dosage: 50 mg, qd
Administration route: Oral
Indication: Type 2 Diabetes Mellitus
Start date: 2011-10-21
End date: 2011-11-03
Levemir
Dosage: 8 iu, qd
Indication: Type 2 Diabetes Mellitus
Start date: 2008-05-02
End date: 2011-11-12
Novorapid
Dosage: 4 iu, tid
Indication: Type 2 Diabetes Mellitus
Start date: 2008-05-02
End date: 2011-11-12
Olmesartan Medoxomil
Dosage: unk
Olmesartan Medoxomil
Dosage: 20 mg, qd
Administration route: Oral
Indication: Hypertension
Start date: 2008-05-12
End date: 2011-11-03
Olmesartan Medoxomil
Dosage: 20 mg, qd
Administration route: Oral
Start date: 2011-12-01
Possible Levemir side effects in 67 year old male
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 67 year old male
Reactions: Syncope, Bundle Branch Block Left
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 40 iu, qd
Indication: Type 2 Diabetes Mellitus
Novolog
Dosage: 40 iu, qd
Indication: Type 2 Diabetes Mellitus
Saxagliptin
Dosage: unk
Indication: Type 2 Diabetes Mellitus
Start date: 2011-08-12
Other drugs received by patient: Aspirin
Possible Levemir side effects in 74 year old female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: 74 year old female
Reactions: Dizziness, Gait Disturbance, Enzyme Abnormality, Blood Glucose Increased, Cardiac Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 15 u, qd
Start date: 2012-07-26
End date: 2012-07-26
Levemir
Dosage: 12 u, qd
Indication: Type 2 Diabetes Mellitus
Start date: 2012-07-25
End date: 2012-07-25
Levemir
Dosage: 22 u, qd
Start date: 2012-07-26
Other drugs received by patient: Toprol-XL
Possible Levemir side effects in 61 year old male
Reported by a consumer/non-health professional from South Africa on 2012-08-13
Patient: 61 year old male
Reactions: Haematemesis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in female
Reported by a consumer/non-health professional from South Africa on 2012-08-10
Patient: female
Reactions: Foetal Exposure During Pregnancy, Large FOR Dates Baby, Jaundice Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 8 u, qd
Indication: Diabetes Mellitus
Start date: 2011-04-01
Novorapid Flexpen
Dosage: 18 u, qd
Indication: Diabetes Mellitus
Start date: 2011-03-22
Possible Levemir side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09
Patient: male
Reactions: Hypoglycaemia, Renal Failure Chronic
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 27 year old female
Reported by a physician from France on 2012-08-09
Patient: 27 year old female
Reactions: Blood Glucose Increased, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Valproic Acid; Lispro Insulin; Clonazepam; Topiramate; Levetiracetam; Carbamazepine
Possible Levemir side effects in 60 year old female
Reported by a physician from Spain on 2012-08-08
Patient: 60 year old female
Reactions: Leukocytoclastic Vasculitis, Skin Ulcer, Type III Immune Complex Mediated Reaction, Drug Administration Error, Extremity Necrosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 60 u, qd
Levemir
Dosage: 60 u, qd
Indication: Type 2 Diabetes Mellitus
Other drugs received by patient: Novorapid; Enalapril Maleate
Possible Levemir side effects in
Reported by a physician from Australia on 2012-08-07
Patient:
Reactions: Foetal Exposure During Pregnancy, Heart Disease Congenital
Adverse event resulted in: death
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 53 year old female
Reported by a physician from Japan on 2012-08-07
Patient: 53 year old female
Reactions: Anti-Insulin Antibody Positive, Hypoglycaemia
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Levemir
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Start date: 2011-09-01
Novorapid CHU Flexpen
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Other drugs received by patient: Lantus; Magmitt; Trazodone Hydrochloride; Ubretid; Benzalin / 00036201 /
Possible Levemir side effects in 58 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-07
Patient: 58 year old male, weighing 62.0 kg (136.4 pounds)
Reactions: Weight Decreased, Palpitations, Mood Altered, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Start date: 2012-05-10
Milnacipran
Dosage: 50 mg
Administration route: Oral
Start date: 2012-07-05
Milnacipran
Dosage: 75 mg
Administration route: Oral
Start date: 2012-05-01
End date: 2012-07-04
Milnacipran
Dosage: 100 mg
Administration route: Oral
Indication: Depression
Start date: 2012-04-30
End date: 2012-05-01
Other drugs received by patient: Oxazepam; Apidra
Possible Levemir side effects in 67 year old female
Reported by a physician from Japan on 2012-08-06
Patient: 67 year old female, weighing 41.0 kg (90.2 pounds)
Reactions: Erythema Multiforme, Oral Herpes, Stevens-Johnson Syndrome
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Daikentyuto
Dosage: unk
Administration route: Oral
Start date: 2012-06-26
End date: 2012-06-28
Irbesartan
Dosage: 50 mg, qd
Administration route: Oral
Start date: 2012-01-01
End date: 2012-06-28
Levemir
Dosage: 16 u, qd
Indication: Diabetes Mellitus
Start date: 2012-05-21
End date: 2012-06-28
Novorapid CHU Flexpen
Dosage: 20 u, qd
Indication: Diabetes Mellitus
Start date: 2012-05-21
End date: 2012-06-28
Other drugs received by patient: Lactomin; Magnesium Oxide; Carboplatin; Taxotere
Possible Levemir side effects in 64 year old male
Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-08-06
Patient: 64 year old male
Reactions: Adenocarcinoma Pancreas, Pancreatitis Chronic, Constipation, Pancreatic Calcification
Drug(s) suspected as cause:
Aceon
Indication: Product Used FOR Unknown Indication
Levemir
Dosage: 30 iu
Indication: Type 2 Diabetes Mellitus
Novolog
Dosage: 64 iu
Indication: Type 2 Diabetes Mellitus
Placebo
Start date: 2011-01-27
Saxagliptin (Saxagliptin)
Dosage: df, unk
Indication: Type 2 Diabetes Mellitus
Other drugs received by patient: Ezetimibe; Metamucil-2; Aspirin; Spiriva; Amylase (Amylase); Flixonase (Flucticasone Propionate); Seretide (Fluticasone Propionate, Salmeterol Xinafoate); Tamsulosin HCL; Ventolin; Lipase (Lipase); Nexium
Possible Levemir side effects in 37 year old female
Reported by a physician from South Africa on 2012-08-06
Patient: 37 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Foetal Distress Syndrome, Maternal Exposure During Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Levemir
Dosage: 8 u, qd
Indication: Gestational Diabetes
Start date: 2012-01-04
End date: 2012-01-25
Novorapid Flexpen
Dosage: 18 u, qd
Indication: Gestational Diabetes
Start date: 2012-01-04
End date: 2012-01-25
Possible Levemir side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-02
Patient: male, weighing 119.8 kg (263.5 pounds)
Reactions: Diabetes Mellitus, Abasia, Perineal Cyst, Decreased Immune Responsiveness, Intervertebral Disc Degeneration, Abnormal Loss of Weight, Oxygen Saturation Decreased, Intervertebral Disc Protrusion, Fistula, Gout, Convulsion, Cholelithiasis, Diarrhoea, Sepsis, Heart Rate Increased, Arthritis, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Colchicine
Administration route: Oral
Indication: Gout
Start date: 2012-05-01
Levemir
Dosage: 52 units/ at night/subcutaneous
Indication: Diabetes Mellitus
Methotrexate
Administration route: Oral
Indication: Intervertebral Disc Protrusion
Start date: 2011-01-01
End date: 2011-01-01
Novolog
Dosage: 40 units/solution before meals
Indication: Diabetes Mellitus
Start date: 2011-01-01
End date: 2011-01-01
Remicade
Indication: Crohn's Disease
Start date: 2004-09-09
End date: 2010-01-01
Remicade
Start date: 2010-01-01
Other drugs received by patient: Flomax; Dilaudid; Ambien; Valium; Hydrochlorothiazide; Cymbalta; Lyrica; Lisinopril; Simvastatin; Nexium; Humalog; Onglyza
Possible Levemir side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient: female
Reactions: Abdominal Pain, Pancreatic Carcinoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Indication: Diabetes Mellitus
Victoza
Indication: Diabetes Mellitus
Possible Levemir side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 66 year old female, weighing 108.8 kg (239.4 pounds)
Reactions: Cardio-Respiratory Arrest, Diabetic Coma
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: 57 u, qd, at night
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Novolog
Dosage: 35 u, tid, before each meal
Indication: Type 2 Diabetes Mellitus
Start date: 2009-01-01
Possible Levemir side effects in 23 year old female
Reported by a physician from Australia on 2012-07-30
Patient: 23 year old female
Reactions: Vomiting, Diarrhoea, Blood PH Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Actrapid
Dosage: unk
Indication: Type 1 Diabetes Mellitus
Levemir
Dosage: 48 u, qd
Indication: Type 1 Diabetes Mellitus
Novorapid
Dosage: mealtime
Indication: Type 1 Diabetes Mellitus
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