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Apidra Side Effects

Generic Name: insulin glulisine

Note: This document contains side effect information about insulin glulisine. Some of the dosage forms listed on this page may not apply to the brand name Apidra.

For the Consumer

Applies to insulin glulisine: parenteral injection

Side effects include:

Hypoglycemia, systemic hypersensitivity, injection site reaction.

For Healthcare Professionals

Applies to insulin glulisine: injectable solution, subcutaneous solution

General

The most common adverse reactions reported include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, and rash.[Ref]

Metabolic

Common (1% to 10%): Hypoglycemia, hypoglycemic seizure

Frequency not reported: Weight gain[Ref]

Hypersensitivity

In clinical trials of ups to 12 months duration, potential systemic allergic reactions were reported in 4.3% (79 of 1833) patients receiving insulin glulisine (the active ingredient contained in Apidra) compared with 3.8% (58 of 1524) patients receiving comparator short-acting insulins. Permanent discontinuation occurred in 1 patient receiving insulin glulisine.[Ref]

Common (1% to 10%): Local hypersensitivity reactions (redness, swelling, and itching at injection site) Uncommon (0.1% to 1%): Systemic allergic reactions including urticaria, chest tightness, dyspnea, allergic dermatitis, and pruritus

Frequency not reported: Anaphylaxis[Ref]

Local

Among patients using continuous subcutaneous insulin infusion pumps, the rates of catheter occlusions and infusion site reactions were similar with insulin glulisine (the active ingredient contained in Apidra) compared with insulin aspart.[Ref]

Common (1% to 10%): Infusion site reactions

Very rare (less than 0.01%): Catheter occlusions[Ref]

Cardiovascular

Common (1% to 10%): Peripheral edema, hypertension[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, pharyngitis, vomiting, nausea[Ref]

Dermatologic

Rare (less than 0.1%): Lipodystrophy[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Apidra (insulin glulisine)." Aventis Pharmaceuticals, Bridgewater, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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