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Levemir (Insulin Detemir Subcutaneous) - Side Effect Reports to FDA

 
 



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 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 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 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 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

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 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 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 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 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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