Humalog Mix 50/50

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

Applies to insulin lispro: suspension

Along with its needed effects, insulin lispro (the active ingredient contained in Humalog) 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:

More common

• Anxious or nervous feeling
• behavior change similar to being drunk
• blurred vision
• chills
• cold sweats
• confusion or difficulty thinking
• depression
• dizziness or lightheadedness
• drowsiness
• excessive hunger
• fast heartbeat
• fever
• headache
• irritability or abnormal behavior
• lower back or side pain
• nightmares
• painful or difficult urination
• restless sleep
• seizures
• shakiness
• slurred speech
• tingling in the hands, feet, lips, or tongue

Less common

• Dry, red, hot, or irritated skin

Rare

• Depression of the skin at the injection site
• dryness of the mouth
• fast or weak pulse
• itching, redness, or swelling at the injection site
• muscle cramps or pain
• nausea
• skin rash or itching over the whole body
• sweating
• thickening of the skin at the injection site
• trouble breathing
• unusual tiredness or weakness
• vomiting

Incidence not known

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• decreased urine
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• hives or itching skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redistribution or accumulation of body fat
• tightness in the chest
• unusual weight gain or loss

Some side effects of insulin lispro 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:

More common

• Body aches or pain
• congestion
• runny nose
• sneezing
• sore throat
• stuffy nose
• tender, swollen glands in the neck
• unusual tiredness or weakness
• voice changes

Incidence not known

• Redness, swelling, or itching at the injection site

Applies to insulin lispro: injectable solution, subcutaneous solution

Adverse reactions observed have included hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus.

Weight gain has been reported with insulin therapy and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.

Very common (10% or more): Hypoglycemia

Frequency not reported: Weight gain

Frequency not reported: Allergic reactions including anaphylaxis

Hypersensitivity side effects have included both local and systemic reactions. Anaphylaxis has been reported. Local reactions have presented as erythema, local edema, and pruritus at the injection site. Most minor reactions to insulin at the injection site resolve in a few days to a few weeks.

Generalized allergy to insulin may present as a whole body rash, dyspnea, wheezing, hypotension, tachycardia, or diaphoresis. In clinical trials, pruritus (with or without rash) was seen in 17 patients receiving human insulin (n=2969) and 30 patients receiving insulin lispro (n=2944).

Common (1% to 10%): Infusion site reactions

Rare (less than 0.1%): Catheter occlusions/month

Rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy. However, long-term glycemic control decreases the risk of diabetic retinopathy.

Uncommon (0.1% to 1%): Refraction disorder, worsening of diabetic retinopathy

Very common (10% or more): Headache (up to 29.6%)

Rare (less than 0.1%): Painful peripheral neuropathy

Rapid improvement in glucose control has been associated with a transitory, reversible acute painful peripheral neuropathy. However, long-term glycemic control decreases the risk.

The clinical significance of the development of these antibody titers is unknown.

Very common (10% or more): Flu syndrome (up to 34.6%), infection (up to 13.6%)

Frequency not reported: Anti-insulin antibody titers

Frequency not reported: Peripheral edema

Insulin may cause sodium retention and edema, especially as metabolic control is improving.

Long-term use of insulin may cause lipodystrophy at the site of repeated injection. Lipodystrophy includes lipohypertrophy, a thickening of adipose tissue, and lipoatrophy, thinning of adipose tissue.

Uncommon (0.1% to 1%): Urticaria, rash

Frequency not reported: Lipodystrophy including lipohypertrophy and lipoatrophy

Common (1% to 10%): Nausea, diarrhea, abdominal pain

Common (1% to 10%): Urinary tract infection, dysmenorrhea

Common (1% to 10%): Myalgia

Very common (10% or more): Pain (up to 19.8%)

Common (1% to 10%): Fever

Very common (10% or more): Pharyngitis (up to 33.3%), rhinitis (up to 24.7%), increased cough (up to 17.3%)

Common (1% to 10%): Sinusitis, bronchitis