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Levemir Side Effects

Report Levemir Side Effects

If you experienced any harmful or unwanted effects of Levemir, please share your experience. This could help to raise awareness about Levemir side effects, identify uknown risks and inform health professionals and patients taking Levemir.

Examples: headache, dizziness


The most commonly reported Levemir side effects are:
GI Dysfunction (18 reports)
Itching (15 reports)
Blood Glucose Increased (13 reports)
Light Headed (11 reports)
Itching Legs (8 reports)
Abomen (7 reports)
Lump At Injection Sight (7 reports)
Pain In Right Arm (6 reports)
Insomnia (5 reports)
Chest (4 reports)
Chest Pain (4 reports)
Anal Leakage (3 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Levemir side effects or compare Levemir side effects

If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

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Levemir Side Effects Reported to FDA

The following Levemir reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Levemir on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Device Malfunction, Blood Glucose Decreased
on Jan 09, 2014 Female from US , 84 years of age, weighting 149.0 lb, was diagnosed with and was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l. Directly after, patient experienced the unwanted or unexpected Levemir side effects: device malfunction, blood glucose decreased. Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l dosage: 18 U, Qd, Subcutaneous.

Anaphylactic Reaction
Patient was taking Levemir (insulin Detemir) Solution For Injection, .0024mol/l. Patient felt the following Levemir side effects: anaphylactic reaction on Jan 09, 2014 from US Additional patient health information: Female , 32 years of age, was diagnosed with and. Levemir (insulin Detemir) Solution For Injection, .0024mol/l dosage: N/A. Patient was hospitalized.

Hypersensitivity
Adverse event was reported on Jan 09, 2014 by a Male taking Levemir (insulin Detemir) Solution For Injection, .0024mol/l (Dosage: N/A) was diagnosed with and. Location: US , 71 years of age, After Levemir was administered, patient encountered several Levemir side effects: hypersensitivity. Patient was hospitalized.

Anaphylactic Reaction
on Jan 09, 2014 Male from US , 45 years of age, was diagnosed with and was treated with Levemir (insulin Detemir) Solution For Injection, .0024mol/l. Directly after, patient experienced the unwanted or unexpected Levemir side effects: anaphylactic reaction. Levemir (insulin Detemir) Solution For Injection, .0024mol/l dosage: N/A.


Preterm Premature Rupture Of Membranes, Exposure During Pregnancy
on Feb 28, 2014 Female from GR , 42 years of age, weighting 167.6 lb, was diagnosed with and was treated with Levemir. Patient felt the following Levemir side effects: preterm premature rupture of membranes, exposure during pregnancy. Levemir dosage: 4 Iu, Qd.

Metabolic Acidosis, Vomiting Projectile, Hypoglycaemia
Patient was taking Levemir Penfill. After Levemir was administered, patient encountered several Levemir side effects: metabolic acidosis, vomiting projectile, hypoglycaemia on Feb 28, 2014 from CA Additional patient health information: Male , 53 years of age, weighting 200.6 lb, . Levemir Penfill dosage: Unk.
Multiple concurrent drugs taken:
  • Avandamet (Unk)
  • Gliclazide (Unk (extended Release Tablet))
  • Januvia (Unk)
  • Nexavar (400 Mg, Bid)
  • Metoprolol (Unk)
  • Sutent (50 Mg, Qd)
  • Asa (Unk)
  • Avalide (Unk)
Patient was hospitalized.

Abortion Induced, Exposure During Pregnancy
Adverse event was reported on Feb 28, 2014 by a Female taking Levemir Flexpen (Dosage: 8 Iu, Qd) was diagnosed with and. Location: GR , 41 years of age, weighting 224.9 lb, Directly after, patient experienced the unwanted or unexpected Levemir side effects: abortion induced, exposure during pregnancy.

Arrhythmia, Palpitations
on Mar 10, 2014 Male from TR , 46 years of age, weighting 211.6 lb, was diagnosed with and was treated with Levemir Flexpen. Patient felt the following Levemir side effects: arrhythmia, palpitations. Levemir Flexpen dosage: 15 U, Qd.
Multiple prescriptions taken:
  • Novorapid Flexpen (Unk)
  • Plavix (Unk (1x1))
  • Coraspin (300 Mg, Qd (1 X1))
  • Darob (Unk (2x1))
  • Diaformin (1000 Mg, Qd)


Device Malfunction, Incorrect Dose Administered
on Jan 09, 2014 Male from US , 49 years of age, was treated with Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l. After Levemir was administered, patient encountered several Levemir side effects: device malfunction, incorrect dose administered. Levemir Flexpen (insulin Detemir) Solution For Injection, .0024mol/l dosage: 70 Units Daily At Bedtime, Subcutaneous. Patient was hospitalized.

Device Malfunction, Blood Glucose Increased
Patient was taking Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: device malfunction, blood glucose increased on Jan 09, 2014 from US Additional patient health information: Male , 82 years of age, weighting 155.0 lb, was diagnosed with and. Levemir dosage: 15 U, Qd At Night.
Associated medications used:
  • Novolog Flexpen (insulin Aspart) Solution For Injection
Patient was hospitalized.

Blood Glucose Increased, Urinary Tract Infection
Adverse event was reported on Jan 09, 2014 by a Female taking Levemir (Dosage: 10 U Qd, Subcutaneous) was diagnosed with and. Location: US , 59 years of age, Patient felt the following Levemir side effects: blood glucose increased, urinary tract infection.

Diabetic Ketoacidosis
on Jan 09, 2014 Female from US , 41 years of age, was diagnosed with and was treated with Levemir. After Levemir was administered, patient encountered several Levemir side effects: diabetic ketoacidosis. Levemir dosage: N/A.
Multiple concurrent drugs taken:
  • Humalog(insulin Lispro)
Patient was hospitalized.

Blood Glucose Increased
on Jan 09, 2014 Male from US , 74 years of age, weighting 201.1 lb, was diagnosed with and was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: blood glucose increased. Levemir dosage: N/A.

Pancreatic Carcinoma Stage Iv, Pneumonia, Sepsis, Hypomagnesaemia, Diabetic Ketoacidosis, Blood Glucose Increased, Blood Glucose Decreased
Patient was taking Levemir Flexpen. Patient felt the following Levemir side effects: pancreatic carcinoma stage iv, pneumonia, sepsis, hypomagnesaemia, diabetic ketoacidosis, blood glucose increased, blood glucose decreased on Mar 28, 2014 from US Additional patient health information: Male , 45 years of age, weighting 165.0 lb, was diagnosed with and. Levemir Flexpen dosage: 25 Units, Qd At Bedtime.
Multiple prescriptions taken:
  • Novolog Flexpen (Sliding Scale, Every 6 Hours Before Meals)
Patient was hospitalized.

Cerebrovascular Accident, Pain, Fatigue, Off Label Use, Blood Glucose Increased
Adverse event was reported on Mar 19, 2014 by a Male taking Levemir Flexpen (Dosage: 27 To 30 Iu Per Day) was diagnosed with and. Location: MX , 95 years of age, weighting 198.4 lb, After Levemir was administered, patient encountered several Levemir side effects: cerebrovascular accident, pain, fatigue, off label use, blood glucose increased.

Premature Baby, Foetal Exposure During Pregnancy
on Feb 19, 2014 Male from GR , weighting 4.85 lb, was diagnosed with and was treated with Levemir. Directly after, patient experienced the unwanted or unexpected Levemir side effects: premature baby, foetal exposure during pregnancy. Levemir dosage: 4 Iu, Qd. Patient was hospitalized.

Myocardial Infarction, Vomiting, Loss Of Consciousness, Product Container Issue, Blood Glucose Increased, Nausea
on Feb 17, 2014 Male from CA , 58 years of age, weighting 145.5 lb, was treated with Levemir Penfill. Patient felt the following Levemir side effects: myocardial infarction, vomiting, loss of consciousness, product container issue, blood glucose increased, nausea. Levemir Penfill dosage: 44 U, Qd (22 Units In The Morning, 22 Units In The Evening). Patient was hospitalized.

Overweight, Dizziness, Loss Of Consciousness, Urine Odour Abnormal, Fall
Patient was taking Levemir. After Levemir was administered, patient encountered several Levemir side effects: overweight, dizziness, loss of consciousness, urine odour abnormal, fall on Feb 11, 2014 from US Additional patient health information: Male , 57 years of age, . Levemir dosage: Dose:100 Unit(s).
Multiple concurrent drugs taken:
  • Solostar
Patient was hospitalized.

Pancreatic Carcinoma, Hepatic Cancer
Adverse event was reported on Feb 07, 2014 by a Male taking Levemir Flexpen (Dosage: 5 Units Once Daily At Night) was diagnosed with and. Location: US , 58 years of age, weighting 205.0 lb, Directly after, patient experienced the unwanted or unexpected Levemir side effects: pancreatic carcinoma, hepatic cancer.
Associated medications used:
  • Humalog (Sliding Scale Three Times Daily)


Angioedema, Rash Maculo-papular
on Mar 12, 2014 Female from DE , 24 years of age, weighting 167.6 lb, was diagnosed with and was treated with Levemir. Patient felt the following Levemir side effects: angioedema, rash maculo-papular. Levemir dosage: 16 Iu, Qd.
Multiple prescriptions taken:
  • Novorapid (31 Iu, Qd)
  • L-thyroxin (50 Ug, Qd)
  • Lamotrigin Dura (25 Mg, Qd)
  • Valproat (1000 Mg, Qd)
Patient was hospitalized.

Pre-eclampsia, Exposure During Pregnancy
on Feb 06, 2014 Female from CL , 31 years of age, weighting 121.3 lb, was diagnosed with and was treated with Levemir Flexpen. After Levemir was administered, patient encountered several Levemir side effects: pre-eclampsia, exposure during pregnancy. Levemir Flexpen dosage: 20 Iu, Qd.
Multiple concurrent drugs taken:
  • Vitamins /00067501/ (1 Tab, Qd)


Rash, Blood Pressure Increased, Blood Glucose Increased
Patient was taking Levemir Flexpen. Directly after, patient experienced the unwanted or unexpected Levemir side effects: rash, blood pressure increased, blood glucose increased on Feb 06, 2014 from US Additional patient health information: Female , 72 years of age, weighting 178.0 lb, was diagnosed with and. Levemir Flexpen dosage: 40 Units Daily.
Associated medications used:
  • Diovan
  • Hydrochloorthiazide
Patient was hospitalized.

Premature Labour, Hypersensitivity, Exposure During Pregnancy
Adverse event was reported on Feb 03, 2014 by a Female taking Levemir Flexpen (Dosage: Unk) was diagnosed with and. Location: ES , 29 years of age, Patient felt the following Levemir side effects: premature labour, hypersensitivity, exposure during pregnancy. Patient was hospitalized.

Cellulitis, Injection Site Hypersensitivity
on Feb 14, 2014 Female from CO , 46 years of age, weighting 145.5 lb, was diagnosed with and was treated with Levemir Flexpen. After Levemir was administered, patient encountered several Levemir side effects: cellulitis, injection site hypersensitivity. Levemir Flexpen dosage: 40 Iu, Qd.

Hyperbilirubinaemia Neonatal, Hypoglycaemia Neonatal, Foetal Exposure During Pregnancy
on Jan 30, 2014 Male from CL , weighting 10.25 lb, was diagnosed with and was treated with Levemir Flexpen. Directly after, patient experienced the unwanted or unexpected Levemir side effects: hyperbilirubinaemia neonatal, hypoglycaemia neonatal, foetal exposure during pregnancy. Levemir Flexpen dosage: 20 Iu, Qd.
Associated medications used:
  • Vitamins /00067501/ (1 Tab, Qd)
Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Levemir Side Effects

    Did You Have a Levemir Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Levemir for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative LEVEMIR Names:INSULIN D

    Active Ingredient: INSULIN D

    Levemir Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3166

    Levemir safety alerts: 2009

    Reported deaths: 171

    Reported hospitalizations: 790

    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]

    Latest Levemir clinical trials