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
- 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
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
- 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.
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]