Firazyr Side Effects

Generic Name: icatibant

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

In Summary

Common side effects of Firazyr 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 (the active ingredient contained in Firazyr) 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:

• 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:

• 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

• Dizziness

• Headache
• nausea
• rash

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 (the active ingredient contained in Firazyr) 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]

Some side effects of Firazyr may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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