NOVOLIN R SIDE EFFECTS

SIDE EFFECTS

• Hypoglycemia
  Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R.
• Insulin initiation and glucose control intensification
  Intensification or rapid improvement in glucose control has been associated with a transitory, reversible ophthalmologic refraction disorder, worsening of diabetic retinopathy, and acute painful peripheral neuropathy. Over the long-term, improved glycemic control decreases the risk of diabetic retinopathy and neuropathy.
• Lipodystrophy
  Long-term use of insulin, including Novolin R, can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy includes lipohypertrophy (thickening of adipose tissue) and lipoatrophy (thinning of adipose tissue), and may affect insulin absorption. Rotate insulin injection sites within the same region to reduce the risk of lipodystrophy.
• Weight gain
  Weight gain can occur with insulin therapies, including Novolin R, and has been attributed to the anabolic effects of insulin and the decrease in glucosuria.
• Peripheral edema
  Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. These symptoms are usually transitory.
• Allergic reactions
  As with other insulins, Novolin R can cause injection site reactions. Severe, life-threatening, generalized allergy, including anaphylaxis may occur with any insulin, including Novolin R.

Clinical Trial Experience

Because clinical trials are conducted under widely varying designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.

Adults With Type 1 Or Type 2 Diabetes

The incidence of adverse reactions during clinical trials comparing Novolin R and insulin aspart in adults with type 1 diabetes mellitus and type 2 diabetes mellitus are listed in the tables below.

Table 1: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 1 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

Table 2: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Adults with Type 2 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

Children And Adolescents With Type 1 Diabetes

The incidence of adverse reactions during a 24-week clinical trial comparing Novolin R and insulin aspart in children and adolescents with type 1 diabetes mellitus are listed in the table below.

Table 3: Adverse Reactions in a 24-Week Trial Comparing Novolin R and Insulin Aspart in Children and Adolescents with Type 1 Diabetes Mellitus Also Treated with NPH Insulin (adverse reactions with an incidence ≥ 5% in the Novolin R treatment group are listed)

Severe Hypoglycemia

Hypoglycemia is the most commonly observed adverse reaction in patients using insulin, including Novolin R. Tables 4 and 5 summarize the incidence of severe hypoglycemia in the Novolin R clinical trials. Severe hypoglycemia was defined as hypoglycemia associated with central nervous system symptoms and requiring intervention of another person or hospitalization. The rates of severe hypoglycemia in the Novolin R clinical trials.

Table 4: Severe Hypoglycemia in Patients with Type 1 Diabetes

Table 5: Severe Hypoglycemia in Patients with Type 2 Diabetes