NovoLog Side Effects

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NovoLog Side Effects
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Generic name: insulin aspart

Please note - some side effects for NovoLog may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of NovoLog - for the consumer

NovoLog Mix 70/30 Cartridges

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NovoLog Mix 70/30 Cartridges:

Redness, swelling, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using NovoLog Mix 70/30 Cartridges:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.


NovoLog Cartridges

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NovoLog Cartridges:

Redness, swelling, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using NovoLog Cartridges:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.


Novolog Cartridges

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Novolog Cartridges:

Redness, swelling, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using Novolog Cartridges:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.


NovoLog Mix 70/30 Vials

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NovoLog Mix 70/30 Vials:

Redness, swelling, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using NovoLog Mix 70/30 Vials:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.


NovoLog Vials

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using NovoLog Vials:

Redness, swelling, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using NovoLog Vials:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing; muscle pain); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast or irregular heartbeat; headache; loss of consciousness; mood changes; seizures; slurred speech; swelling; tremor; trouble breathing; trouble concentrating; unusual hunger; unusual sweating; weakness.

For the professional

Novolog Injection

Clinical trials comparing Novolog® Mix 70/30 with Novolin® 70/30 did not demonstrate a difference in frequency of adverse events between the two treatments.

Adverse events commonly associated with human insulin therapy include the following:

Body as whole: Allergic reactions.

Skin and Appendages: Local injection site reactions or rash or pruritus, as with other insulin therapies, occurred in 7% of all patients on Novolog® Mix 70/30 and 5% on Novolin® 70/30. Rash led to withdrawal of therapy in <1% of patients on either drug .

Hypoglycemia: see WARNINGS and PRECAUTIONS.

Other: Small elevations in alkaline phosphatase were observed in patients treated in Novolog® controlled clinical trials. There have been no clinical consequences of these laboratory findings.

By body system

Cardiovascular side effects

Cardiovascular side effects have included hyperinsulinemia. Given the high frequency of both microvascular and macrovascular diseases in patients with diabetes and hyperinsulinemia, some experts are evaluating insulin as a possible atherogenic agent. Controversy and continued study surround the role of hyperinsulinemia as the precursor of hypertension.

Other cardiovascular risk factors that are accentuated in persons with carbohydrate intolerance and hypertension include abnormalities in platelet function, clotting factors, the fibrinolytic system, and dyslipidemia. The relationship between diabetes, insulin, and these disorders is currently under investigation.

Insulin may contribute to the pathogenesis of hypertension by stimulating the sympathetic nervous system, promoting renal sodium retention, and/or stimulating vascular smooth muscle hypertrophy. It may induce dyslipidemia by promoting hepatic synthesis of very low density lipoproteins (VLDLs).

Insulin may stimulate heart rate in the absence of hypoglycemia.

Dermatologic side effects

Dermatologic side effects of insulin have included lipohypertrophy (insulin is lipogenic) and lipoatrophy (probably immunologically-mediated). The incidence of lipoatrophy has been markedly decreased with the use of purer forms of pork insulin or biosynthetic human insulin and when injection sites were alternated. Without proper hygiene, subcutaneous insulin injections has been complicated by infection.

Endocrine side effects

Permanent neuropsychological impairment has been associated with recurrent episodes of severe hypoglycemia.

In one retrospective study of 600 randomly selected patients with insulin-treated diabetes mellitus, the only reliable predictors of severe hypoglycemia were a history of hypoglycemia, a history of hypoglycemia-related injury or convulsion, and the duration of insulin therapy. Those with a history of hypoglycemia had been treated with insulin for 17.4 years, which was significantly longer than the 14.3 years in the insulin-treated patients without a history of hypoglycemia.

Human insulin does not appear to be associated with hypoglycemic episodes more often than animal insulin. Caution is recommended when switching from animal (either bovine or pork) to purified porcine insulin or biosynthetic human insulin, however, because of increased potency or bioavailability.

Endocrine side effects have included hypoglycemia, which has been the most common and serious side effect of insulin, occurring in approximately 16% of type 1 and 10% of type II diabetic patients (the incidence varies greatly depending on the populations studied, types of insulin therapy, etc). Although there are counterregulatory endocrinologic responses to hypoglycemia, some responses have been decreased, inefficient, or absent in some patients. Severe hypoglycemia has usually presented first as confusion, sweating, or tachycardia, and has resulted in coma, seizures, cardiac arrhythmias, neurological deficits, and death. Blood or urine glucose monitoring is recommended in patients who are at risk of hypoglycemia or who do not recognize the signs and symptoms of hypoglycemia. The risk for developing hypoglycemia has been higher in patients receiving intensive or continuous infusion insulin therapy. The association between insulin and dyslipidemia is currently being evaluated.

Gastrointestinal side effects

Gastrointestinal side effects have been reported rarely. GI distress has tended to resolve after dose reduction.

General side effects

Intensive insulin therapy causes an increase in body fat as a result of the elimination of glycosuria and reduction in 24-hour energy expenditure. The reduction in 24-h energy expenditure is the result of an insulin-associated decrease in triglyceride/free fatty acid cycling and nonoxidative glucose and protein metabolism.

General side effects have included weight gain, sometimes presenting as edema associated with abrupt restoration of glucose control in a patient whose control was previously poor. Weight gain may have been due to more efficient use of calories during insulin therapy, suggesting additional benefits of dietary and exercise modifications. Patients on intensive insulin therapy have been more likely to experience weight gain.

Hematologic side effects

The effects of insulin-induced hypoglycemia on hemostasis may explain some of the clinical observations of embolic phenomenon during treatment of diabetic ketoacidosis.

Limited data show that diabetics have a significantly lower basal concentration of tissue plasminogen activator.

Hematologic side effects have included an increase in the concentration of von Willebrand factor due to insulin-induced hypoglycemia. Increased von Willebrand factor, combined with hypoglycemia-associated decreased plasma volume and increased plasma viscosity, may have predisposed patients to reduced peripheral perfusion or embolic phenomenon. A single case of insulin-induced hemolytic anemia has been reported.

Hypersensitivity side effects

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 purer forms of pork insulin or biosynthetic human insulin. Local reactions have presented as erythema, swelling, heat, or subcutaneous nodules. They usually occurred within the first two weeks of therapy, then disappeared. True allergy to insulin has been rare, and sensitization was usually associated with specific animal proteins in bovine and less pure forms of porcine insulins. Severe, life-threatening, generalized allergy, including anaphylaxis, may occur with any insulin product, including insulin aspart. Anaphylactic reactions with insulin aspart have been reported post- approval. Generalized allergy to insulin may also cause whole body rash (including pruritus), dyspnea, wheezing, hypotension, tachycardia, or diaphoresis.

A diabetic patient with true allergy to insulin can undergo desensitization. Desensitization kits and protocols are available from some insulin manufacturers.

Immunologic side effects

Immunologic side effects have included the formation of anti-insulin antibodies, particularly when animal insulin formulations were used. The presence of these antibodies caused the elimination half-life of insulin to increase.

Increases in levels of anti-insulin antibodies that react with both human insulin and insulin aspart have been observed in patients treated with insulin aspart. These antibodies do not appear to cause deterioration in HbA1c or to necessitate increases in insulin dose.

Immunologic analysis of anaphylaxis to some insulin preparations in some cases has revealed markedly elevated serum levels of lgE and lgG to protamine, but not to regular insulin.

Metabolic side effects

Rare cases of hypophosphatemia have been associated with the use of glucose, insulin, and potassium infusions during the treatment of myocardial infarction.

Metabolic side effects have included reports of hypokalemia and hypomagnesemia, particularly in patients treated for diabetic ketoacidosis (DKA). Insulin increases the intracellular transport of phosphate, which often results in hypophosphatemia during treatment of DKA.

Ocular side effects

Ocular side effects have included reports bilateral presyopia (blurry vision) during the beginning of therapy. This was thought to be due to changes in the osmotic equilibrium between the lens and the ocular fluids, and was usually self-limited.

Renal side effects

Hypoglycemia is associated with increased plasma dopamine, epinephrine, and plasma renin activity. Acute changes in renal function during insulin-induced hypoglycemia, therefore, may result from direct stimulation of the efferent sympathetic nerves to the kidney and hormonal counterregulatory mechanisms.

Renal effects have included reports of significantly decreased renal plasma flow, glomerular filtration rate, and significantly increased urinary albumin excretion rate from insulin-induced hypoglycemia. These changes were usually reversible upon resolution of hypoglycemia.

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