Ilaris Side Effects

Generic Name: canakinumab

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

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

For the Consumer

Applies to canakinumab: subcutaneous powder for solution

Along with its needed effects, canakinumab (the active ingredient contained in Ilaris) 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 or nurse immediately if any of the following side effects occur while taking canakinumab:

More common
  • Body aches or pain
  • chills
  • congestion
  • cough
  • diarrhea
  • dryness or soreness of the throat
  • fever
  • headache
  • hoarseness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • shivering
  • shortness of breath
  • sneezing
  • stuffy or runny nose
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble sleeping
  • trouble swallowing
  • unusual tiredness or weakness
  • voice changes
  • vomiting

Some side effects of canakinumab 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
  • Abdominal or stomach pain
  • 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 or lightheadedness
  • feeling of constant movement of self or surroundings
  • increased weight
  • muscle or bone pain
  • sensation of spinning
  • weakness

For Healthcare Professionals

Applies to canakinumab: subcutaneous powder for injection


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


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


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 (the active ingredient contained in Ilaris)

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


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


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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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