Applies to insulin isophane: subcutaneous suspension.

Serious side effects of Insulin isophane

Along with its needed effects, insulin isophane 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 isophane:

Incidence not known

• Anxiety
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• chest tightness
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• cough
• decreased urine
• depression
• difficulty swallowing
• dizziness
• dry mouth
• fast heartbeat
• headache
• hives, itching, or rash
• increased hunger
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea or vomiting
• nightmares
• numbness or tingling in the hands, feet, or lips
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• shakiness
• slurred speech
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

Other side effects of Insulin isophane

Some side effects of insulin isophane 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:

Incidence not known

• Redness, swelling, or itching skin at the injection site
• weight gain

For Healthcare Professionals

Applies to insulin isophane: subcutaneous suspension.

Cardiovascular

Frequency not reported: Sodium retention and edema^[Ref]

Insulin may cause sodium retention and edema, especially with intensified insulin therapy. Combination use with thiazolidinediones has resulted in fluid retention which has led to or exacerbated heart failure.^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Lipodystrophy^[Ref]

Long-term use of insulin can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissues).^[Ref]

General

The most common adverse reactions reported with this insulin include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, weight gain, and edema.^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Local reactions such as redness, swelling, or itching at the injection site

Very rare (less than 0.01%): Anaphylactic reactions^[Ref]

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 and then disappear. 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.^[Ref]

Immunologic

Increases in titers of anti-insulin antibodies that react with human insulin have been observed; some data indicates the increase is transient. The clinical significance of these antibodies is unknown; it does not appear to cause deterioration in glycemic control.^[Ref]

Frequency not reported: Formation of anti-insulin antibodies^[Ref]

Metabolic

Very common (10% or more): Hypoglycemia

Rare (less than 0.1%): Insulin resistance

Frequency not reported: Hypokalemia, hyperglycemia, diabetic ketoacidosis, hyperosmolar hyperglycemic non-ketotic syndrome, hypomagnesemia, hypophosphatemia^[Ref]

Hypoglycemia is the most common adverse reaction of all insulin therapies. The timing of hypoglycemia generally reflects the time-action profile of the administered insulin, however, the time action profile of any insulin may vary considerably in different individuals or at different times in the same individual depending on dose, site of injection, blood supply, temperature, and physical activity. Other factors such as changes in food intake (timing of meals, amount or type of food) and concomitant medications will also affect the risk of hypoglycemia.

Hypokalemia, which is due to a shift in potassium from the extracellular to the intracellular space, occurs with all insulins. Hypokalemia and hypomagnesemia has been reported, particularly in patients treated for diabetic ketoacidosis (DKA). Insulin increases the intracellular transport of phosphate, which often results in hypophosphatemia during treatment of DKA. In situations in which not enough insulin is available to control blood glucose, hyperglycemia, diabetic ketoacidosis, and hyperosmolar hyperglycemic non-ketotic syndrome may occur.^[Ref]

Ocular

Transitory, reversible ophthalmologic refraction disorder and worsening of diabetic retinopathy has been reported with insulin initiation and glucose control intensification. Over the long-term, improved glycemic control decreases the risk for diabetic neuropathy.^[Ref]

Frequency not reported: Transitory, reversible ophthalmologic refraction disorder, worsening diabetic neuropathy^[Ref]

Local

Common (1% to 10%): Injection site hypertrophy

Frequency not reported: Injection site reactions^[Ref]

Injection site reactions including pain, redness, hives, inflammation, bruising, swelling, and itching have occurred. These usually resolve in a few days to a few weeks; rotation of the injection site reduces the risk of these reactions developing.^[Ref]

Nervous system

Acute painful peripheral neuropathy has been reported with insulin initiation and glucose control intensification. Over the long-term, improved glycemic control decreases the risk for neuropathy.^[Ref]

Frequency not reported: Acute painful peripheral neuropathy^[Ref]

Other

Frequency not reported: Weight gain^[Ref]

Weight gain can occur with insulin use; it is believed to be due to the anabolic effects of insulin and the decrease in glycosuria.^[Ref]