Levemir® side effects

Talk to your health care provider about possible side effects.

What are the possible side effects of Levemir®?

Levemir® may cause serious side effects that lead to death, including:

  • Low blood sugar. Signs and symptoms include:

- anxiety
- irritability
- mood changes
- dizziness
- sweating
- confusion
- headache

Your insulin dose may need to change because of:

  • change in level of physical activity or exercise
  • weight gain or loss
  • increased stress
  • illness
  • change in diet

Other common side effects of Levemir® may include:

  • reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet and if taken with thiazolidinediones (TZDs) possible heart failure.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

These are not all the possible side effects of Levemir®. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What is Levemir® (insulin detemir injection) 100 U/mL?

  • Levemir® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.
  • Levemir® is not meant for use to treat diabetic ketoacidosis.

Levemir® Important Safety Information

Do not share your Levemir® FlexTouch® with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Who should not take Levemir®?

Do not take Levemir® if:

  • you have an allergy to Levemir® or any of the ingredients in Levemir®.

Before taking Levemir®, tell your health care provider about all your medical conditions including, if you are:

  • pregnant, plan to become pregnant, or are breastfeeding.
  • taking new prescription or over-the-counter medicines, including supplements.

Talk to your health care provider about how to manage low blood sugar.

How should I take Levemir®?

  • Read the Instructions for Use and take exactly as directed.
  • Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
  • Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.
    • Do not use the exact same spot for each injection.
    • Do not inject where the skin has pits, is thickened, or has lumps.
    • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
  • Do not reuse or share your needles or syringes with other people. You may give other people a serious infection, or get a serious infection from them.
  • Never inject Levemir® into a vein or muscle.

What should I avoid while taking Levemir®?

  • Do not drive or operate heavy machinery, until you know how it affects you.
  • Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of Levemir®?

Serious side effects can lead to death, including:

Low blood sugar. Some signs and symptoms include:

  • anxiety, irritability, mood changes, dizziness, sweating, confusion, and headache.

Your insulin dose may need to change because of:

  • change in level of physical activity, weight gain or loss, increased stress, illness, or change in diet.

Other common side effects may include:

  • reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, swelling of your hands and feet and if taken with thiazolidinediones (TZDs) possible heart failure.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please click here for Levemir® Prescribing Information.

Levemir® is a prescription medication.

Look up your cost at MyLevemirCost.com.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1‑800-FDA-1088.

If you need assistance with prescription costs, help may be available. Visit www.pparx.org or call 1‑888-4PPA-NOW.

Talk to your health care provider about your diabetes management plan, including diet and exercise.