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Humalog Mix 50 / 50 Side Effects

Generic Name: insulin lispro / insulin lispro protamine

Note: This document contains side effect information about insulin lispro / insulin lispro protamine. Some of the dosage forms listed on this page may not apply to the brand name Humalog Mix 50 / 50.

For the Consumer

Applies to insulin lispro / insulin lispro protamine: subcutaneous suspension

Along with its needed effects, insulin lispro/insulin lispro protamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin lispro/insulin lispro protamine:

Incidence Not Known

  • Anxiety
  • blurred vision
  • chills
  • cold sweats
  • confusion
  • convulsions
  • cool, pale skin
  • cough
  • decreased urine
  • depression
  • difficulty with swallowing
  • dizziness
  • dry mouth
  • fast heartbeat
  • flushing or redness of the skin
  • headache
  • hives
  • increased hunger
  • increased thirst
  • irregular heartbeat
  • itching
  • loss of appetite
  • muscle pain or cramps
  • nausea or vomiting
  • nervousness
  • nightmares
  • numbness or tingling in the hands, feet, or lips
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • seizures
  • shakiness
  • shortness of breath
  • skin rash
  • slurred speech
  • sweating
  • swelling
  • tightness in the chest
  • unusual tiredness or weakness
  • unusually warm skin
  • wheezing

Some side effects of insulin lispro / insulin lispro protamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence Not Known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • redistribution or accumulation of body fat

For Healthcare Professionals

Applies to insulin lispro / insulin lispro protamine: subcutaneous suspension

General

The most common adverse reactions observed with insulin therapy include hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.[Ref]

Metabolic

Very common (10% or more): Hypoglycemia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Local reactions such as redness, swelling, or itching at the injection site

Very rare (less than 0.01%): Systemic reactions[Ref]

Hypersensitivity side effects have included both local and systemic reactions. These reactions are becoming rare (less than 1% of patients) due to the use of biosynthetic human insulin. Local reactions have presented as erythema, swelling, heat, or subcutaneous nodules. They usually occurred within the first two weeks of therapy and then disappear. Systemic allergy is a generalized allergy to insulin which may present as a rash over the whole body, shortness of breath, wheezing, drop in blood pressure, fast pulse, or sweating. Severe cases may be life-threatening.[Ref]

Cardiovascular

Frequency not reported: Peripheral edema[Ref]

Insulin may cause sodium retention and edema, especially if previously poor metabolic control is improved by intensified insulin therapy.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Lipodystrophy

Frequency not reported: Rash, pruritus[Ref]

Immunologic

Frequency not reported: Anti-insulin antibodies[Ref]

Other

Frequency not reported: Weight gain[Ref]

Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.[Ref]

Local

Frequency not reported: Injection site reactions[Ref]

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching, may occur. These reactions are usually transitory and may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Humalog Mix75/25 (insulin lispro-insulin lispro protamine)" Lilly, Eli and Company, Indianapolis, IN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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