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GI Dysfunction (17)
Itching (15)
Blood Glucose Increased (13)
Light Headed (11)
Itching Legs (8)
Lump At Injection Sight (7)
Abomen (6)
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Levemir Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 2902 

Dialysis, Staphylococcal Bacteraemia, Urinary Tract Infection, Rhabdomyolysis, Renal Failure, Septic Shock, Loss Of Consciousness, Fall, Encephalopathy (8348939-9)
on May 04, 2012 Male from FRANCE , 55 years of age, weighting 198.4 lb, was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: dialysis, staphylococcal bacteraemia, urinary tract infection, rhabdomyolysis, renal failure, septic shock, loss of consciousness, fall, encephalopathy. Levemir dosage: N/A.
Associated medications used:
  • Victrelis (800 Mg;tid;po)
  • Apidra
  • Rebetol (1200 Mg;qd;po)
  • Viraferonpeg (150 Mcg;qw;sc)
  • Aldactone
Patient was hospitalized.

Fall, Foot Fracture (8346085-1)
Patient was taking Levemir. Patient felt the following Levemir side effects: fall, foot fracture on Apr 19, 2012 from GERMANY Additional patient health information: Female , 50 years of age, . Levemir dosage: N/A.
Multiple prescriptions taken:
  • Pioglitazone Hydrochloride (Pioglitazone/metformin 30/1700 Mg Per Oral)
  • Apidra
  • Metformin Hcl


Haematuria, Prostate Cancer, Diabetes Mellitus Inadequate Control, Rectal Cancer, Glycosylated Haemoglobin Increased, Bladder Transitional Cell Carcinoma (8343126-2)
Adverse event was reported on Apr 18, 2012 by a Male taking Levemir (Dosage: N/A) . Location: JAPAN , 69 years of age, After Levemir was administered, patient encountered several Levemir side effects: haematuria, prostate cancer, diabetes mellitus inadequate control, rectal cancer, glycosylated haemoglobin increased, bladder transitional cell carcinoma.
Multiple concurrent drugs taken:
  • Pletaal Od (cilostazol)
  • Atelec (cilnidipine)
  • Preminent (hydrochlorothiazide, Losartan Potassium)
  • Miglitol
  • Amaryl
  • Actos (15 Mg (15 Mg, 1 In 1 D) Per Oral)
Patient was hospitalized.

Fall, Blood Glucose Decreased, Dehydration, Syncope (8340613-8)
on May 02, 2012 Female from UNITED STATES , weighting 141.5 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: fall, blood glucose decreased, dehydration, syncope. Levemir dosage: N/A.
Associated medications used:
  • Simvastatin
  • Aggrenox
  • Aggrenox
  • Aggrenox
  • Keppra
  • Tamoxifen Citrate
  • Norco
  • Supplements
Patient was hospitalized.


Meningioma Benign (8337233-8)
on Apr 26, 2012 Female from JAPAN , 53 years of age, weighting 136.7 lb, was treated with Levemir. Patient felt the following Levemir side effects: meningioma benign. Levemir dosage: 12 U, Qd.
Multiple prescriptions taken:
  • Metformin Hcl (1500mg/po)
  • Metformin Hcl (1500mg/po)


Dizziness, Flushing, Pain, Burning Sensation, Pallor, Blood Glucose Decreased, Tinnitus, Asthenia (8335229-3)
Patient was taking Levemir. After Levemir was administered, patient encountered several Levemir side effects: dizziness, flushing, pain, burning sensation, pallor, blood glucose decreased, tinnitus, asthenia on Apr 25, 2012 from UNITED STATES Additional patient health information: Male , 53 years of age, weighting 242.5 lb, was diagnosed with
  • type 2 diabetes mellitus
and. Levemir dosage: 70 U, Qd.
Multiple concurrent drugs taken:
  • Novolog (30 U, Qd)
Patient was hospitalized.

Rhinorrhoea, Urinary Tract Infection, Weight Increased, Renal Impairment, Pleural Effusion (8333919-X)
Adverse event was reported on May 16, 2011 by a Female taking Levemir (Dosage: N/A) . Location: UNITED STATES , 57 years of age, Directly after, patient experienced the unwanted or unexpected Levemir side effects: rhinorrhoea, urinary tract infection, weight increased, renal impairment, pleural effusion.
Associated medications used:
  • Bystolic
  • Insulin, Regular (insulin)
  • Valturna (1 Df (300 Mg Aliskiren + 320 Mg Valsartan))
  • Norvasc
  • Hydrochlorothiazide


Off Label Use, Blood Glucose Increased, Salivary Gland Resection (8323409-2)
on Apr 25, 2012 Female from GERMANY , 66 years of age, was treated with Levemir. Patient felt the following Levemir side effects: off label use, blood glucose increased, salivary gland resection. Levemir dosage: 26 U, Each Morning.
Multiple prescriptions taken:
  • Bydureon (2 Mg, Weekly (1/w))
Patient was hospitalized.

Erythema, Oedema Peripheral, Arthralgia, Asthenia (8321615-4)
on Apr 17, 2012 Male from FRANCE , 66 years of age, weighting 189.6 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Levemir. After Levemir was administered, patient encountered several Levemir side effects: erythema, oedema peripheral, arthralgia, asthenia. Levemir dosage: 24 Iu, Qd.
Multiple concurrent drugs taken:
  • Novorapid (Unk)
  • Amlodipine Besylate (Unk)
  • Aspirin (Unk)
  • Irbesartan (150 Mg, Qd)
  • Plavix (Unk)


Pain In Extremity, Pain In Jaw, Pancreatic Cyst, Incisional Hernia, Chest Pain, Abdominal Distension (8321462-3)
Patient was taking Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: pain in extremity, pain in jaw, pancreatic cyst, incisional hernia, chest pain, abdominal distension on Apr 30, 2012 from UNITED STATES Additional patient health information: Male , 69 years of age, weighting 235.0 lb, was diagnosed with
  • diabetes mellitus
  • arterial stent insertion
and. Levemir dosage: 30 Units.
Associated medications used:
  • Simvastatin (1 Tab)
Patient was hospitalized.

Blood Glucose Increased (8313898-1)
Adverse event was reported on Apr 26, 2012 by a Female taking Levemir (Dosage: 26 Units) was diagnosed with
  • type 2 diabetes mellitus
and. Location: UNITED STATES , 78 years of age, weighting 180.0 lb, Patient felt the following Levemir side effects: blood glucose increased.

Erythema (8307364-7)
on Apr 13, 2012 Female from GERMANY , 69 years of age, was treated with Levemir. After Levemir was administered, patient encountered several Levemir side effects: erythema. Levemir dosage: N/A.
Multiple concurrent drugs taken:
  • Metformin Hcl (Intial Dose:250mg Increase To 500mg:1weeks)


Intentional Overdose, Suicidal Ideation (8305736-8)
on Apr 13, 2012 Female from GERMANY , 68 years of age, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: intentional overdose, suicidal ideation. Levemir dosage: Unk.

Hypoglycaemic Coma, Hypothermia (8298369-3)
Patient was taking Levemir. Patient felt the following Levemir side effects: hypoglycaemic coma, hypothermia on Apr 11, 2012 from JAPAN Additional patient health information: Female , 66 years of age, weighting 103.6 lb, was diagnosed with
  • type 2 diabetes mellitus
and. Levemir dosage: 8 U, Qd.
Multiple prescriptions taken:
  • Novorapid Chu Flexpen (14 U, Qd)
Patient was hospitalized.

Hip Fracture, Cerebrovascular Accident (8294531-4)
Adverse event was reported on Apr 09, 2012 by a Female taking Levemir (Dosage: 22 U, Qd) . Location: UNITED STATES , 76 years of age, weighting 200.0 lb, After Levemir was administered, patient encountered several Levemir side effects: hip fracture, cerebrovascular accident.
Multiple concurrent drugs taken:
  • Coumadin
Patient was hospitalized.

Injection Site Haematoma, Hyperhidrosis, Injection Site Mass, Injection Site Erythema, Implant Site Pruritus (8287309-9)
on Apr 16, 2012 Female from UNITED STATES , 63 years of age, weighting 210.0 lb, was diagnosed with
  • type 2 diabetes mellitus
and was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: injection site haematoma, hyperhidrosis, injection site mass, injection site erythema, implant site pruritus. Levemir dosage: 60 Ml.

Hypoglycaemia (8280758-4)
on Apr 10, 2012 Male from UNITED KINGDOM , 50 years of age, was treated with Levemir. Patient felt the following Levemir side effects: hypoglycaemia. Levemir dosage: N/A.
Multiple prescriptions taken:
  • Clarithromycin
  • Novorapid
  • Levothyroxine Sodium
  • Lisinopril


Pneumonia (8275553-6)
Patient was taking Levemir. After Levemir was administered, patient encountered several Levemir side effects: pneumonia on Feb 13, 2012 from BRAZIL Additional patient health information: Male , 76 years of age, . Levemir dosage: Unk. Patient was hospitalized.

Blood Glucose Increased, Vision Blurred (8261516-3)
Adverse event was reported on Mar 27, 2012 by a Male taking Levemir (Dosage: N/A) . Location: BRAZIL , 27 years of age, Directly after, patient experienced the unwanted or unexpected Levemir side effects: blood glucose increased, vision blurred.

Blood Urea Increased, Blood Creatine Increased, Blood Glucose Increased, Hyperkalaemia (8250032-0)
on Aug 03, 2010 Female from UNITED STATES , 56 years of age, weighting 550.7 lb, was treated with Levemir. Patient felt the following Levemir side effects: blood urea increased, blood creatine increased, blood glucose increased, hyperkalaemia. Levemir dosage: N/A.
Multiple prescriptions taken:
  • Oxycontin
  • Metformin Hcl
  • Neurobene (cyanocobalamin)
  • Codeine Sulfate
  • Bystolic
  • Tylox
  • Tekturna (300 Mg Daily)
  • Tekturna Hct (300/25 Mg Daily, Oral)


Blood Glucose Increased, Vision Blurred (8242835-3)
on Mar 19, 2012 Male from BRAZIL , 27 years of age, was treated with Levemir. After Levemir was administered, patient encountered several Levemir side effects: blood glucose increased, vision blurred. Levemir dosage: N/A.

Pneumonia (8242826-2)
Patient was taking Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: pneumonia on Feb 13, 2012 from BRAZIL Additional patient health information: Male , 76 years of age, . Levemir dosage: Unk. Patient was hospitalized.

Alanine Aminotransferase Increased, Weight Decreased, Liver Function Test Abnormal, Fatigue, Aspartate Aminotransferase Increased, Dyspnoea, Yellow Skin, Decreased Appetite, Malaise (8242817-1)
Adverse event was reported on Mar 21, 2012 by a Male taking Levemir (Dosage: 1 Df, 10-14 E) . Location: NETHERLANDS , weighting 176.4 lb, Patient felt the following Levemir side effects: alanine aminotransferase increased, weight decreased, liver function test abnormal, fatigue, aspartate aminotransferase increased, dyspnoea, yellow skin, decreased appetite, malaise.
Multiple prescriptions taken:
  • Clopidogrel (1 Df, Qd)
  • Ascal Cardio (1 Df, Qd)
  • Metformin Hcl (1 Df, Bid)
  • Valsartan (1 Df, Qd)


Dyspnoea, Rash, Throat Tightness, Visual Impairment, Fatigue, Hypoaesthesia, Injection Site Rash, Paraesthesia Oral (8240458-3)
on Mar 19, 2012 Female from UNITED STATES , 52 years of age, weighting 120.0 lb, was diagnosed with
  • type 1 diabetes mellitus
and was treated with Levemir. After Levemir was administered, patient encountered several Levemir side effects: dyspnoea, rash, throat tightness, visual impairment, fatigue, hypoaesthesia, injection site rash, paraesthesia oral. Levemir dosage: 5 U, Single.

Bronchitis, Cough, Injection Site Reaction, Pain Of Skin (8238441-7)
on May 10, 2010 Female from UNITED STATES , 50 years of age, weighting 388.9 lb, was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: bronchitis, cough, injection site reaction, pain of skin. Levemir dosage: N/A.
Associated medications used:
  • Metformin Hcl
  • Lisinopril
  • Pravastatin
  • Aspirin
  • Extavia (0.25 Mg, Qod, Subcutaneous)
  • Extavia (0.25 Mg, Qod, Subcutaneous)
  • Glucotriol (glipizide)
  • Lasix 40 (furosemide)


Showing 1-25 of 2902 

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Levemir Information

Alternative LEVEMIR Names:INSULIN D

Active Ingredient: INSULIN D

Levemir Dosage, Warnings, Usage.

Side Effects reported to FDA: 2902. View Levemir Adverse Reports

Levemir safety alerts: 2009

Reported deaths: 144

Reported hospitalizations: 688

Levemir Insulin (Novo Nordisk)

Audience: Patients, pharmacists, diabetes healthcare professionals

[UPDATED 08/26/2009]  FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

[Posted 06/13/2009] FDA notified patients and healthcare professionals that some stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. are being sold in the U.S. market, may not have been stored and handled properly, and may be dangerous for patients to use. The agency is advising patients who use Levemir insulin to:

  • Check your personal supply of insulin to determine if you have Levemir insulin from one of the following lots: XZF0036, XZF0037, and XZF0038. 
  • Do not use your Levemir insulin if it is from one of these lots.
  • Always visually inspect your insulin before using it. Levemir is a clear and colorless solution.
  • Contact the Novo Nordisk Customer Care Center at 1-800-727-6500 for what to do with vials from these lots or if you have any other questions.

[08/26/2009 - News Release- FDA]
[08/04/2009 - Patient Safety News video - FDA YouTube Channel]
[06/13/2009 - News Release - FDA]

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