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Icatibant Side Effects

In Summary

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

For the Consumer

Applies to icatibant: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by icatibant. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking icatibant:

Less common:
  • Fever

Minor Side Effects

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

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:
  • Dizziness
Incidence not known:
  • Headache
  • nausea
  • rash

For Healthcare Professionals

Applies to icatibant: subcutaneous solution


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


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]


Common (1% to 10%): Rash, pruritus, erythema
Uncommon (0.1% to 1%): Generalized urticaria[Ref]


Common (1% to 10%): Nasopharyngitis, nasal congestion
Uncommon (0.1% to 1%): Pharyngitis, asthma, cough[Ref]


Common (1% to 10%): Gastroenteritis, nausea
Uncommon (0.1% to 1%): Vomiting[Ref]

Nervous system

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


Common (1% to 10%): Pyrexia
Uncommon (0.1% to 1%): Asthenia, fatigue, contusion[Ref]


Common (1% to 10%): Transaminase increased
Uncommon (0.1% to 1%): Liver function test abnormal[Ref]


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


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


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


Uncommon (0.1% to 1%): Herpes zoster
Frequency not reported: Anti-icatibant antibodies[Ref]


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


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


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


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

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

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

Not all side effects for icatibant may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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