Applies to insulin lispro: solution.

Serious side effects of Insulin lispro

Along with its needed effects, insulin lispro 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

• Anxiety
• blurred vision
• body aches or pain
• chills
• cold sweat
• confusion
• cool, pale skin
• cough
• depression
• difficulty breathing
• dizziness
• ear congestion
• fast heartbeat
• fever
• headache
• increased hunger
• loss of consciousness
• loss of voice
• muscle aches
• nausea
• nervousness
• nightmares
• runny or stuffy nose
• seizures
• shakiness
• slurred speech
• sneezing
• sore throat
• unusual tiredness or weakness

Rare

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• chest tightness
• difficulty swallowing
• dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, weak pulse
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• noisy breathing
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redistribution or accumulation of body fat
• redness of the skin
• sweating
• thickening of the skin at the injection site
• tingling of the hands or feet
• unusual weight gain or loss

Incidence not known

• Decreased urine
• dry mouth
• irregular heartbeat
• increased thirst
• loss of appetite
• mood changes
• muscle pain or cramps
• numbness or tingling in the hands, feet, or lips
• reddish brown itchy, thick, and scaly patches with small bumps at the injection site
• vomiting

Other side effects of Insulin lispro

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:

Less common

• Redness, swelling, bruising, rash, or itching at the injection site

For Healthcare Professionals

Applies to insulin lispro: injectable solution, subcutaneous solution.

General

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

Metabolic

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

Very common (10% or more): Hypoglycemia

Frequency not reported: Weight gain^[Ref]

Hypersensitivity

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).^[Ref]

Frequency not reported: Allergic reactions including anaphylaxis^[Ref]

Local

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

Rare (less than 0.1%): Catheter occlusions/month^[Ref]

Ocular

Uncommon (0.1% to 1%): Refraction disorder, worsening of diabetic retinopathy^[Ref]

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.^[Ref]

Nervous system

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

Rare (less than 0.1%): Painful peripheral neuropathy^[Ref]

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

Immunologic

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

Frequency not reported: Anti-insulin antibody titers^[Ref]

The clinical significance of the development of these antibody titers is unknown.^[Ref]

Cardiovascular

Insulin may cause sodium retention and edema, especially as metabolic control is improving.^[Ref]

Frequency not reported: Peripheral edema^[Ref]

Dermatologic

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

Frequency not reported: Lipodystrophy including lipohypertrophy and lipoatrophy^[Ref]

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.^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, abdominal pain^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, dysmenorrhea^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia^[Ref]

Other

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

Common (1% to 10%): Fever^[Ref]

Respiratory

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^[Ref]