Prescription medicine
Canakinumab Brand names: Ilaris
Canakinumab (Ilaris) is a prescription medicine with an FDA approval on record since 2009. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the canakinumab FDA label on DailyMed (effective June 8, 2026, Novartis Pharmaceuticals Corporation); the BLA 125319 record on Drugs@FDA; every canakinumab label on DailyMed.
Highlights of the record
FDA label of June 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageILARIS is an interleukin-1β blocker indicated for the treatment of:
Periodic Fever Syndromes ( 1.1 ): - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: ◾ Familial Cold Auto-inflammatory Syndrome (FCAS) ◾ Muckle-Wells Syndrome (MWS) - Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients - Hyperimmunoglobulin D
Forms and strengths
- 150 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- June 17, 2009 Ilaris, Novartis Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 10,756 through July 30, 2026
What is canakinumab used for?
From the label: indications and usageILARIS is an interleukin-1β blocker indicated for the treatment of:
Periodic Fever Syndromes ( 1.1 ): - Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older, including: ◾ Familial Cold Auto-inflammatory Syndrome (FCAS) ◾ Muckle-Wells Syndrome (MWS) - Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients - Hyperimmunoglobulin D Syndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients - Familial Mediterranean Fever (FMF) in adult and pediatric patients
Active Still’s Disease, including Adult-Onset Still’s Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in […]
Conditions named in the indications of canakinumab's FDA labels, with every medicine labeled for each:
From other canakinumab labelsGout: Gout Flares ILARIS is indicated for the symptomatic treatment of adult patients with gout flares in whom non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine are contraindicated, are not tolerated, or do not provide an adequate …
Source: FDA drug label (Ilaris), Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 7d271f3b-e4f9-4d80-8dcf-28d49123f80e), via openFDA; the full label on DailyMed
What does the patient leaflet for canakinumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ILARIS?ILARIS can cause serious side effects, including: Increased risk of serious infections. ILARIS can lower the ability of your immune system to fight infections. Your healthcare provider should: test you for tuberculosis (TB) before you receive ILARIS. monitor you closely for symptoms of TB during treatment with ILARIS. check you for symptoms of any type of infection before, during, and after your treatment with ILARIS. Tell your healthcare provider right away if you have any symptoms of an infection, such as fever, sweats or chills, cough, flu-like symptoms, weight loss, shortness of breath, blood in your phlegm, sores on your body, warm or painful areas on your body, diarrhea or stomach pain, or feeling very tired. See "What are possible side effects of ILARIS?" for more information about side effects.
Source: FDA drug label (Ilaris), Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 7d271f3b-e4f9-4d80-8dcf-28d49123f80e), via openFDA; the full label on DailyMed
Is there a generic for canakinumab (Ilaris)?
No generic canakinumab is approved (Drugs@FDA, October 8, 2026).
- 2009 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the canakinumab label say about other medicines?
The canakinumab label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Warfarin | drug interactions | This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin). |
Source: FDA drug label (Ilaris), Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 7d271f3b-e4f9-4d80-8dcf-28d49123f80e), via openFDA; the full label on DailyMed
What do FAERS reports show for canakinumab?
The FDA Adverse Event Reporting System holds 10,756 reports that list canakinumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 470 are coded as a death and 2,405 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Canakinumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other