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Ilaris Side Effects

Generic name: canakinumab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 4, 2025.

Note: This document provides detailed information about Ilaris Side Effects associated with canakinumab. Some dosage forms listed on this page may not apply specifically to the brand name Ilaris.

Applies to canakinumab: subcutaneous solution.

Serious side effects of Ilaris

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 side effects

  • bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chest tightness
  • chills
  • cough
  • diarrhea
  • difficult, burning, or painful urination
  • dryness or soreness of the throat
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • hoarseness
  • joint pain
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • muscle aches and pains
  • nausea
  • shivering
  • sneezing
  • stomach pain
  • stuffy or runny nose
  • sweating
  • tender, swollen glands in the neck
  • 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

Other side effects of Ilaris

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 side effects

  • 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.

General adverse events

The most frequently reported side effects included nasopharyngitis, upper respiratory tract infections, and urinary tract infections.

The most frequently reported side effects in patients with Cryopyrin-Associated Periodic Syndromes were nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight increased, musculoskeletal pain, upper respiratory tract infection and vertigo.

The most frequently reported side effects in patients with Tumor Necrosis Factor (TNF) Receptor Associated Periodic Syndrome, Hyperimmunoglobulin D Syndrome/Mevalonate Kinase Deficiency, and Familial Mediterranean Fever were injection-site reactions and nasopharyngitis.

The most frequently reported side effects in patients with gout flares were infections and infestations.

The most frequently reported side effects in patients with Systemic Juvenile Idiopathic Arthritis were infections predominantly of the upper respiratory tract.[Ref]

Dermatologic

Gastrointestinal

Genitourinary

Hematologic

Hepatic

Hypersensitivity

Local

Metabolic

Musculoskeletal

Nervous system

Ocular

Other

Infection included gastroenteritis, respiratory tract infection, upper respiratory tract infection and intra-abdominal abscess following appendectomy.[Ref]

Renal

Respiratory

References

1. (2023) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals

2. (2025) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals Pty Ltd

3. (2021) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals UK Ltd

4. Cerner Multum, Inc. "UK Summary of Product Characteristics."

5. Cerner Multum, Inc. "Australian Product Information."

6. (2009) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals

Further information

Ilaris side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.