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Canakinumab Side Effects

For the Consumer

Applies to canakinumab: subcutaneous powder for solution, subcutaneous solution

Along with its needed effects, canakinumab 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, subcutaneous solution

Gastrointestinal

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

Genitourinary

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

Hematologic

Very common (10% or more): Leukopenia

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

Hepatic

Rare (less than 0.1%): Elevated transaminases

Frequency not reported: Elevated serum bilirubin[Ref]

Hypersensitivity

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

Immunologic

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

Local

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

Musculoskeletal

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]

Other

Very common (10% or more): Ear infection

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

Respiratory

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

Dermatologic

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

Metabolic

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

Renal

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

References

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

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

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

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