|
Index of reports
> Serious Reactions (116)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Levemir (Insulin Detemir Subcutaneous) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 116 Next >>
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 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 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 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 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 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 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 37 year old female
Reported by a physician from South Africa on 2012-07-27
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
Other drugs received by patient: Adalat
Possible Levemir side effects in 38 year old female
Reported by a physician from South Africa on 2012-07-25
Patient: 38 year old female
Reactions: Maternal Exposure During Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Levemir
Dosage: 4 u, qd
Indication: Gestational Diabetes
Start date: 2011-07-28
Novorapid Flexpen
Dosage: 12 u, qd
Indication: Gestational Diabetes
Start date: 2011-07-28
Possible Levemir side effects in female
Reported by a consumer/non-health professional from Australia on 2012-07-20
Patient: female
Reactions: Drug Dose Omission, Malaise, Device Misuse, Wrong Drug Administered, Hypoglycaemia, Bronchitis, Accidental Overdose, Lower Respiratory Tract Infection
Drug(s) suspected as cause:
Humalog
Indication: Product Used FOR Unknown Indication
Levemir
Indication: Product Used FOR Unknown Indication
Rebif
Indication: Product Used FOR Unknown Indication
Start date: 2010-05-17
Possible Levemir side effects in 11 year old female
Reported by a physician from Spain on 2012-07-20
Patient: 11 year old female, weighing 25.0 kg (55.0 pounds)
Reactions: Injection Site Discolouration, Malaise, Face Oedema, Dizziness, Vision Blurred
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Insulin Lispro
Possible Levemir side effects in 38 year old female
Reported by a physician from South Africa on 2012-07-16
Patient: 38 year old female
Reactions: Maternal Exposure During Pregnancy, PRE-Eclampsia
Drug(s) suspected as cause:
Levemir
Dosage: 4 u, qd
Indication: Gestational Diabetes
Start date: 2011-07-28
Novorapid Flexpen
Dosage: 12 u, qd
Indication: Gestational Diabetes
Start date: 2011-07-28
Possible Levemir side effects in 37 year old female
Reported by a physician from South Africa on 2012-07-16
Patient: 37 year old female, weighing 80.0 kg (176.0 pounds)
Reactions: Foetal Distress Syndrome, Caesarean Section, Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Levemir
Dosage: 8 u, qd
Indication: Gestational Diabetes
Start date: 2012-01-04
Novorapid Flexpen
Dosage: 18 u, qd
Indication: Gestational Diabetes
Start date: 2012-01-04
Other drugs received by patient: Adalat
Possible Levemir side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-16
Patient: 61 year old female
Reactions: Face Oedema, Oedema Peripheral, Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cellcept
Dosage: 500 mg, daily
Administration route: Oral
Indication: Pemphigus
Start date: 2012-04-18
End date: 2012-04-19
Levemir
Dosage: unk
Indication: Diabetes Mellitus
Start date: 2012-01-23
End date: 2012-05-10
Novorapid
Dosage: unk
Indication: Diabetes Mellitus
Start date: 2012-01-23
End date: 2012-05-10
Ramipril
Dosage: unk
Administration route: Oral
Indication: Hypertension
Start date: 2003-01-01
End date: 2012-05-03
Other drugs received by patient: Nexium; Amlodipine Besylate; Tramadol HCL; Calcium Carbonate; Zocor; Levothyroxine Sodium; Alendronic Acid; Potassium Chloride; Aldactone; Aspirin; Prednisone TAB; Metformin; Bisoprolol
Possible Levemir side effects in 37 year old male
Reported by a physician from Japan on 2012-07-13
Patient: 37 year old male, weighing 81.0 kg (178.2 pounds)
Reactions: Hypothermia, Hypoglycaemic Unconsciousness, Ventricular Arrhythmia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lasix
Dosage: 80 mg, qd
Administration route: Oral
Lasix
Dosage: 40 mg, qd
Administration route: Oral
Indication: Diabetic Nephropathy
Start date: 2010-12-06
Levemir
Dosage: 12 u, qd
Indication: Type 2 Diabetes Mellitus
Start date: 2008-08-20
End date: 2012-02-01
Trichlormethiazide
Dosage: 3 mg, qw
Administration route: Oral
Indication: Diabetic Nephropathy
Start date: 2010-08-13
Other drugs received by patient: Diovan; Lipitor; Novorapid CHU Flexpen; Allopurinol; Enalapril Maleate
Possible Levemir side effects in 85 year old female
Reported by a consumer/non-health professional from United States on 2012-07-10
Patient: 85 year old female, weighing 79.4 kg (174.6 pounds)
Reactions: Blood Glucose Decreased, Urinary Tract Infection, Spinal Column Stenosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in 37 year old male
Reported by a physician from Japan on 2012-06-29
Patient: 37 year old male
Reactions: Hypothermia, Hypoglycaemic Unconsciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levemir
Dosage: unknown/ sc
Indication: Type 2 Diabetes Mellitus
Novorapid CHU Flexpen
Dosage: unknown/sc
Indication: Type 2 Diabetes Mellitus
Possible Levemir side effects in 62 year old female
Reported by a consumer/non-health professional from Brazil on 2012-06-28
Patient: 62 year old female
Reactions: Thrombosis, Pneumonia
Drug(s) suspected as cause:
Levemir
Dosage: unk
Indication: Product Used FOR Unknown Indication
Novorapid Flexpen
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Levemir side effects in 73 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2012-06-21
Patient: 73 year old male
Reactions: Pruritus Generalised, Hypotension, Rash Macular
Drug(s) suspected as cause:
Levemir
Possible Levemir side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: male, weighing 119.8 kg (263.5 pounds)
Reactions: Intervertebral Disc Protrusion, Fistula, Gout, Diabetes Mellitus, Abasia, Convulsion, Cholelithiasis, Perineal Cyst, Decreased Immune Responsiveness, Diarrhoea, Heart Rate Increased, Intervertebral Disc Degeneration, Abnormal Loss of Weight, Oxygen Saturation Decreased, 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
Start date: 2010-01-01
Remicade
Indication: Crohn's Disease
Start date: 2004-09-01
End date: 2010-01-01
Possible Levemir side effects in 53 year old male
Reported by a consumer/non-health professional from Brazil on 2012-06-05
Patient: 53 year old male
Reactions: Renal Transplant, Drug Ineffective, Visual Impairment
Drug(s) suspected as cause:
Levemir
Dosage: unk
Indication: Product Used FOR Unknown Indication
Novolin R
Dosage: unk
Possible Levemir side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-01
Patient: male, weighing 119.8 kg (263.5 pounds)
Reactions: Intervertebral Disc Protrusion, Fistula, Diabetes Mellitus, Gout, Abasia, Convulsion, Cholelithiasis, Perineal Cyst, Decreased Immune Responsiveness, Diarrhoea, Heart Rate Increased, Intervertebral Disc Degeneration, Abnormal Loss of Weight, Oxygen Saturation Decreased, 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: 2004-09-01
End date: 2010-01-01
Remicade
Start date: 2010-01-01
Possible Levemir side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2012-05-25
Patient: 66 year old male, weighing 103.0 kg (226.6 pounds)
Reactions: Anaemia, Thrombocytopenia
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Novorapid
Possible Levemir side effects in 51 year old male
Reported by a consumer/non-health professional from United States on 2012-05-25
Patient: 51 year old male, weighing 149.7 kg (329.3 pounds)
Reactions: Colon Cancer
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Actos MET; Lisinopril; Simvastatin
Possible Levemir side effects in male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-23
Patient: male
Reactions: Aplastic Anaemia
Drug(s) suspected as cause:
Levemir
Indication: Product Used FOR Unknown Indication
Victoza
Indication: Product Used FOR Unknown Indication
Possible Levemir side effects in 11 year old female
Reported by a physician from Spain on 2012-05-23
Patient: 11 year old female, weighing 25.0 kg (55.0 pounds)
Reactions: Injection Site Discolouration, Face Oedema, Malaise, Vision Blurred, Dizziness
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Insulin Lispro
Possible Levemir side effects in 43 year old female
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: 43 year old female, weighing 127.0 kg (279.4 pounds)
Reactions: Haemoglobin Decreased, Pain, Gait Disturbance, Vaginal Haemorrhage
Drug(s) suspected as cause:
Levemir
Other drugs received by patient: Iron; Clobetasol Propionate; Vitamin C / 00008001 /; Provera
Page 1 Next >>
|
