Firazyr Side Effects

Generic Name: icatibant

Note: This page contains information about the side effects of icatibant. Some of the dosage forms included on this document 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

In addition to its needed effects, some unwanted effects may be caused by icatibant (the active ingredient contained in Firazyr). 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:

• 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:

• 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]

Not all side effects for Firazyr 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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