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Canakinumab Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 1, 2023.

Applies to canakinumab: subcutaneous solution.

Serious side effects of Canakinumab

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

Incidence not known

Other side effects of Canakinumab

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

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

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

3. (2009) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals

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.