HUMULIN N SIDE EFFECTS

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the labeling:

• Hypoglycemia
• Hypoglycemia Due to Medication Errors
• Hypersensitivity Reactions
• Hypokalemia

The following additional adverse reactions have been identified during post-approval use of HUMULIN N. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure.

Allergic Reactions

Some patients taking HUMULIN N have experienced erythema, local edema, and pruritus at the site of injection. These conditions were usually self-limiting. Severe cases of generalized allergy (anaphylaxis) have been reported.

Peripheral Edema

Some patients taking HUMULIN N have experienced sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy.

Lipodystrophy

Administration of insulin subcutaneously, including HUMULIN N, has resulted in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue) in some patients.

Localized Cutaneous Amyloidosis

Localized cutaneous amyloidosis at the injection site has occurred. Hyperglycemia has been reported with repeated insulin injections into areas of localized cutaneous amyloidosis; hypoglycemia has been reported with a sudden change to an unaffected injection site.

Weight gain

Weight gain has occurred with insulins, including HUMULIN N, and has been attributed to the anabolic effects of insulin and the decrease in glycosuria.

Immunogenicity

Development of antibodies that react with human insulin have been observed with all insulins, including HUMULIN N.

SRC: NLM .