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Icatibant Side Effects

In Summary

Commonly reported side effects of icatibant include: hematoma at injection site, injection site reaction, urticaria at injection site, bruising at injection site, burning sensation at injection site, erythema at injection site, irritation at injection site, pain at injection site, and swelling at injection site. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to icatibant: subcutaneous solution

Along with its needed effects, icatibant may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking icatibant:

Less Common

  • Fever

Some side effects of icatibant may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Less Common

Incidence Not Known

For Healthcare Professionals

Applies to icatibant: subcutaneous solution

General

The most common adverse reactions were injection site reactions, pyrexia, transaminase increased, dizziness, and rash.[Ref]

Local

Injection site reaction includes bruising, hematoma, burning, erythema, hypoesthesia, irritation, numbness, edema, pain, pressure sensation, pruritus, swelling, urticaria, or warmth at the site of injection.[Ref]

Very common (10% or more): Injection site reaction (97%)[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, erythema

Uncommon (0.1% to 1%): Generalized urticaria[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, nasal congestion

Uncommon (0.1% to 1%): Pharyngitis, asthma, cough[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, nausea

Uncommon (0.1% to 1%): Vomiting[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache[Ref]

Other

Common (1% to 10%): Pyrexia

Uncommon (0.1% to 1%): Asthenia, fatigue, contusion[Ref]

Hepatic

Common (1% to 10%): Transaminase increased

Uncommon (0.1% to 1%): Liver function test abnormal[Ref]

Hematologic

Common (1% to 10%): Prothrombin time prolonged[Ref]

Renal

Common (1% to 10%): Blood creatinine phosphokinase increased[Ref]

Metabolic

Uncommon (0.1% to 1%): Weight increased, blood glucose increased, hyperuricemia, hyperglycemia[Ref]

Immunologic

Uncommon (0.1% to 1%): Herpes zoster

Frequency not reported: Anti-icatibant antibodies[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hot flush[Ref]

Genitourinary

Uncommon (0.1% to 1%): Proteinuria[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle spasm[Ref]

References

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

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

3. "Product Information. Firazyr (icatibant)." Shire US Inc, Florence, KY.

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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