Levemir Side Effects and Adverse Reactions

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Levemir Side Effects and Adverse Reactions
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Adverse Reactions

Adverse events commonly associated with human insulin therapy include the following:

Body as Whole: allergic reactions (see PRECAUTIONS, Allergy).

Skin and Appendages: lipodystrophy, pruritus, rash. Mild injection site reactions occurred more frequently with Levemir than with NPH human insulin and usually resolved in a few days to a few weeks (see PRECAUTIONS, Allergy).

Other:

Hypoglycemia: (see WARNINGS and PRECAUTIONS).

In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, the incidence of severe hypoglycemia with Levemir was comparable to the incidence with NPH, and, as expected, greater overall in patients with type 1 diabetes (Table 4).

Weight gain:

In trials of up to 6 months duration in patients with type 1 and type 2 diabetes, Levemir was associated with somewhat less weight gain than NPH (Table 4). Whether these observed differences represent true differences in the effects of Levemir and NPH insulin is not known, since these trials were not blinded and the protocols (e.g., diet and exercise instructions and monitoring) were not specifically directed at exploring hypotheses related to weight effects of the treatments compared. The clinical significance of the observed differences has not been established.

What are the possible side effects of Levemir?

* low blood sugar (hypoglycemia). Symptoms of low blood sugar may include:

* sweating



* trouble concentrating or confusion

* dizziness or lightheadedness



* blurred vision

* shakiness



* slurred speech

* hunger



* anxiety, irritability or mood changes

* fast heart beat



* headache

* tingling of lips and tongue




Severe low blood sugar can cause unconsciousness (passing out), seizures, and death. Know your symptoms of low blood sugar. Follow your healthcare provider’s instructions for treating low blood sugar. Talk to your healthcare provider if low blood sugar is a problem for you.

* Serious allergic reaction (whole body reaction). Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
* Reactions at the injection site (local allergic reaction). You may get redness, swelling, and itching at the injection site. If you keep having skin reactions or they are serious, talk to your healthcare provider. You may need to stop using Levemir and use a different insulin. Do not inject insulin into skin that is red, swollen, or itchy.
* Skin thickens or pits at the injection site (lipodystrophy). Change (rotate) where you inject your insulin to help to prevent these skin changes from happening. Do not inject insulin into this type of skin.
* Swelling of your hands and feet.
* Vision changes
* Low potassium in your blood (hypokalemia)

These are not all of the possible side effects from Levemir. Ask your healthcare provider or pharmacist for more information.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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