Ilaris Side Effects

Please note - some side effects for Ilaris may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ilaris - for the Consumer

Ilaris

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ilaris:

Cold or flu symptoms; diarrhea; dizziness; headache; mild pain, redness, or swelling at the injection site; mild sore throat; nausea; sinus inflammation; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; open sore that does not heal; persistent cough; persistent pain, swelling, or redness at the injection site; severe or persistent headache or dizziness; signs of infection (eg, fever, chills, or sore throat; warm, red, or painful skin; increased or painful urination); unusual bruising; unusual lumps; unusual tiredness or weakness.

Ilaris Side Effects - for the Professional

Ilaris

The most common adverse reactions reported by patients with CAPS treated with Ilaris are nasopharyngitis, diarrhea, influenza, headache and nausea. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Respiratory

Respiratory side effects including nasopharyngitis (34%), rhinitis (17%), bronchitis (11%), and pharyngitis (11%) have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (20%), nausea (14%), and gastroenteritis (11%) have been reported.

Other

Other side effects including influenza (17%) and increased weight (11%) have been reported.

Nervous system

Vertigo has been reported in 9% to 14% of patients in CAPS studies, exclusively in Muckle-Wells Syndrome (MWS) patients, and reported as a serious adverse event in two cases. All events resolved with continued treatment with canakinumab.

Nervous system side effects including headache (14%) and vertigo (11%) have been reported.

Musculoskeletal

Musculoskeletal side effects including musculoskeletal pain (11%) have been reported.

Local

Local side effects including subcutaneous injection site reactions have been reported.

No severe injection site reactions were reported and none led to discontinuation of treatment.

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