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Ilaris Side Effects

Generic Name: canakinumab

Medically reviewed by Last updated on Sep 11, 2020.

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.

For the Consumer

Applies to canakinumab: subcutaneous solution

Side effects requiring immediate medical attention

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

Incidence not known

  • Chest pain
  • lightheadedness or dizziness
  • skin rash, itching
  • swelling of the face, tongue, and throat

Side effects not requiring immediate medical attention

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

  • 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
  • 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, subcutaneous solution


Very common (10% or more): Diarrhea (20%), nausea (14%), gastroenteritis, tonsillitis, upper abdominal pain, gastroesophageal reflux disease[Ref]


Very common (10% or more): Urinary tract infection[Ref]


Very common (10% or more): Leukopenia

Frequency not reported: Hemoglobin increased, decreased white blood cells, decreased neutrophils, decreased platelets[Ref]


Rare (less than 0.1%): Elevated transaminases

Frequency not reported: Elevated serum bilirubin[Ref]


Frequency not reported: Hypersensitivity reactions (unspecified)[Ref]


Very common (10% or more): Influenza (17%), viral infection (13%)[Ref]


Very common (10% or more): Injection site reaction[Ref]


Very common (10% or more): Musculoskeletal pain (11%), arthralgia

Common (1% to 10%): Back pain[Ref]

Nervous system

Very common (10% or more): Headache (14%), dizziness/vertigo (11%)[Ref]


Very common (10% or more): Ear infection

Common (1% to 10%): Fatigue/asthenia[Ref]


Very common (10% or more): Nasopharyngitis (34%), rhinitis (17%), bronchitis (11%), pneumonia, sinusitis, rhinitis, pharyngitis, upper respiratory tract infection[Ref]


Very common (10% or more): Cellulitis[Ref]


Very common (10% or more): Weight gain (11%)[Ref]


Very common (10% or more): Creatinine clearance decreased, proteinuria[Ref]


1. "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.