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.

Precautions

Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol (including beer and wine) may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are using this medicine unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency: There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of insulin and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after you get the injection.

You may have some skin redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject this medicine into a skin area that is red, swollen, or itchy.

Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Too much insulin aspart protamine and insulin aspart combination can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin aspart with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.

If symptoms of low blood sugar occur, eat glucose tablets or gel to relieve the symptoms. Also, check your blood for low blood sugar. Go to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, changes in insulin regimen, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination, ketones in the urine, loss of appetite, stomachache, nausea, or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, or unusual thirst. If these symptoms occur, check your blood sugar level and call your doctor for instructions.

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:

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]

See also:

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