Humulin® S, Humulin® I, Humulin® M3 100 Units/ml (insulin human): Undesirable effects

Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin dose and other factors e.g. a patient`s level of diet and exercise.

Local allergy in patients is common (≥ 1/100 to < 1/10). Redness, swelling, and itching can occur at the site of insulin injection. This condition usually resolves in a few days to a few weeks. In some instances, local reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique.

Systemic allergy, which is very rare (< 1/10,000) but potentially more serious, is a generalised allergy to insulin. It may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalised allergy may be life-threatening. In the rare event of a severe allergy to Humulin, treatment is required immediately. A change of insulin or desensitisation may be required.

Lipodystrophy at the injection site is uncommon (≥ 1/1,000 to < 1/100).

Skin and subcutaneous tissue disorders: Frequency “unknown”: Cutaneous amyloidosis

Skin and subcutaneous tissue disorders:

Lipodystrophy and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the given injection area may help to reduce or prevent these reactions.

Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic control is improved by intensified insulin therapy.

Reference

Humulin S (soluble insulin) 100 cartridge Summary of Product Characteristics

Humulin S 100 vial Summary of Product Characteristics

Humulin I (isophane insulin) 100 cartridge Summary of Product Characteristics

Humulin I 100 SPC KwikPen Summary of Product Characteristics

Humulin I 100 SPC vial Summary of Product Characteristics

Humulin M3 (30% soluble/70% isophane insulin) 100 cartridge Summary of Product Characteristics

Humulin M3 100 KwikPen Summary of Product Characteristics

Humulin M3 100 vial Summary of Product Characteristics