Canakinumab Side Effects

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

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 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 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 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

• Very common (10% or more): Cellulitis
• Common (1% to 10%): Measles, varicella^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (20%), gastroenteritis (11%), nausea (14%), upper abdominal pain (up to 14%), gastroesophageal reflux disease
• Frequency not reported: Vomiting^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (13%)
• Common (1% to 10%): Vulvovaginal candidiasis^[Ref]

Hematologic

• Very common (10% or more): Decreased white blood cells (up to 10%), leukopenia, thrombocytopenia (16%)
• Common (1% to 10%): Decreased neutrophils, decreased platelet count, increased blood triglycerides, lymph node abscess, transient cytopenia
• Frequency not reported: Increased hemoglobin^[Ref]

Hepatic

• Common (1% to 10%): High ALT and/or AST
• Rare (less than 0.1%): Elevated transaminases
• Frequency not reported: Elevated serum bilirubin^[Ref]

Hypersensitivity

• Frequency not reported: Hypersensitivity reactions^[Ref]

Local

• Very common (10% or more): Injection site reaction (up to 13%)^[Ref]

Metabolic

• Very common (10% or more): Weight gain (11%)
• Common (1% to 10%): Hypertriglyceridemia^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia, musculoskeletal pain (11%)
• Common (1% to 10%): Back pain^[Ref]

Nervous system

• Very common (10% or more): Dizziness/vertigo (up to 14%), headache (14%)^[Ref]

Ocular

• Frequency not reported: Conjunctivitis

Other

• Very common (10% or more): Ear infection, infections (54%), increased uric acid levels (43%), influenza (17%), viral infection (13%)
• Common (1% to 10%): Adenovirus infection, fatigue/asthenia, otitis media, sepsis
• Frequency not reported: Opportunistic infections^[Ref]

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

Renal

• Very common (10% or more): Decreased creatinine clearance, proteinuria^[Ref]

Respiratory

• Very common (10% or more): Tonsillitis (up to 54%), nasopharyngitis (34%), rhinitis (17%), bronchitis (11%), pneumonia, sinusitis, pharyngitis (11%), upper respiratory tract infection
• Frequency not reported: Pharyngotonsillitis^[Ref]

Further information

Canakinumab 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.

Medical Disclaimer