Insulin Aspart/insulin Aspart Protamine Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 22, 2024.

Applies to insulin aspart/insulin aspart protamine: subcutaneous suspension.

Serious side effects

Along with its needed effects, insulin aspart/insulin aspart 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 aspart/insulin aspart protamine:

More common side effects

• anxiety
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• chills
• cold sweats
• confusion
• cool, pale skin
• depression
• difficulty with breathing
• dizziness
• fast heartbeat
• headache
• increased hunger
• loss of consciousness
• nausea
• nervousness
• nightmares
• seizures
• sensation of pins and needles
• shakiness
• slurred speech
• stabbing pain
• unusual tiredness or weakness

Incidence not known

• bloating or swelling of the face, arms, hands, lower legs, or feet
• change in vision
• chest tightness
• cough
• difficulty swallowing
• hives, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• rapid weight gain
• redistribution or accumulation of body fat
• thickening of the skin at the injection site
• unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur while taking insulin aspart/insulin aspart protamine:

Symptoms of overdose

• decreased amount of urine
• dry mouth
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps

Other side effects

Some side effects of insulin aspart/insulin aspart 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:

Most common

• Back pain
• belching
• 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
• body aches or pain
• bone pain
• diarrhea
• dryness or soreness of the throat
• ear congestion
• general feeling of discomfort or illness
• heartburn
• hoarseness
• indigestion
• joint pain
• loss of voice
• runny or stuffy nose
• shivering
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• tender, swollen glands in the neck
• trouble sleeping
• voice changes
• vomiting

For healthcare professionals

Applies to insulin aspart/insulin aspart protamine: subcutaneous suspension.

General adverse events

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 (69%)
• Frequency not reported: Weight gain^[Ref]

Hypoglycemia is the most frequently reported adverse reaction with insulin therapy. It occurs if the dose of the insulin is too high in relation to the insulin requirement. In clinical trials, the frequency of hypoglycemia varied with patient population, dose regimens, and level of glycemic control. Weight gain has been attributed to the anabolic effects of insulin and the decrease in glycosuria.^[Ref]

Hypersensitivity

• Very rare (less than 0.01%): Anaphylactic reactions
• Frequency not reported: Allergic reactions^[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.^[Ref]

Ocular

• Frequency not reported: Transient, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy^[Ref]

Rapid improvement or intensification of in glucose control has been associated with transitory, reversible ophthalmologic refraction disorder; however, long-term glycemic control decreases the risk of diabetic retinopathy.^[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

• Frequency not reported: Lipodystrophy, rash, pruritus^[Ref]

Gastrointestinal

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

Immunologic

• Common (1% to 10%): Influenza-like symptoms
• Frequency not reported: Anti-insulin antibodies^[Ref]

In a 3-month, open-label study, anti-insulin antibodies and cross-reacting anti-insulin antibodies were monitored in patients using this insulin compared with an insulin mix of 70% NPH (human insulin isophane suspension) and 30% regular (human insulin injection). Changes in cross-reactive antibodies were more common after this mix but these changes did not correlate with a change in HbA1c or increase in insulin dose. The clinical significance of these antibodies has not been established. Antibodies did not increase further after long-term exposure (greater than 6 months).^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, skeletal pain^[Ref]

Nervous system

• Very common (10% or more): Headache (19%)
• Common (1% to 10%): Neuropathy^[Ref]

Rapid improvement or intensification of in glucose control has been associated with acute and painful peripheral neuropathy; however, long-term glycemic control decreases the risk of neuropathy.^[Ref]

Other

• Postmarketing reports: Medication errors in which other insulins have been accidentally substituted^[Ref]

Respiratory

• Common (1% to 10%): Pharyngitis, rhinitis , upper respiratory tract infection^[Ref]

Further information

Insulin aspart/insulin aspart protamine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer