Ilaris Side Effects

Generic Name: canakinumab

Note: This page contains side effects data for the generic drug canakinumab. It is possible that some of the dosage forms included below may not apply to the brand name Ilaris.

It is possible that some side effects of Ilaris may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to canakinumab: subcutaneous powder for solution

As well as its needed effects, canakinumab (the active ingredient contained in Ilaris) may cause unwanted side effects that require 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 canakinumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.

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