Apidra Adverse Reactions

Hypoglycaemia, the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high in relation to the insulin requirement.
The following related adverse reactions from clinical investigations were listed as follows by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000), not known (cannot be estimated from the available data).
Description of selected adverse reactions: Metabolism and nutrition disorders: Very common: Hypoglycemia.
Symptoms of hypoglycaemia usually occur suddenly. They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Hypoglycemia can become severe and may lead to unconsciousness and/or convulsions and may result in temporary or permanent impairment of brain function or even death.
Apidra 100 Units/ml solution for injection in a vial: Cases of hyperglycaemia have been reported with Apidra when used with CSII (see Precautions) that has led to Diabetic Ketoacidosis (DKA); most of the cases were related to handling errors or pump system failure. The patient should always follow the Apidra specific instructions and always have access to alternative insulin delivery system in case of pump system failure.
Skin and subcutaneous tissue disorders: Common: injection site reactions and local hypersensitivity reactions.
Local hypersensitivity reactions (redness, swelling and itching at the injection site) may occur during treatment with insulin. These reactions are usually transitory and normally they disappear during continued treatment.
Rare: Lipodystrophy.
Not Known: Cutaneous amyloidosis.
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 (see Precautions).
General disorders: Uncommon: Systemic hypersensitivity reactions.
Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnea, allergic dermatitis and pruritus. Severe cases of generalized allergy, including anaphylactic reaction, may be life-threatening.
Medication errors have been reported in which other insulins, particularly long-acting insulins, have been accidentally administered instead of insulin glulisine.