What the label lists and what reports show
Canakinumab side effects
Canakinumab's FDA label: “The most common adverse reactions (>10%) are nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight increased, musculoskeletal pain, and vertigo.” FAERS holds 10,756 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (1,431 reports).
- No generic listed
Check it at the source: the canakinumab FDA label on DailyMed (effective June 8, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ILARIS?ILARIS can cause serious side effects, including: See “What is the most important information I should know about ILARIS?” decreased ability of your body to fight infections (immunosuppression). For people treated with medicines that cause immunosuppression like ILARIS, the chances of getting cancer may increase. serious allergic reactions. Stop taking ILARIS, contact your healthcare provider, and get emergency help right away if you have any of these symptoms of a serious allergic reaction: ◦ swelling of the lips, tongue, mouth, or face ◦ trouble breathing ◦ wheezing ◦ severe itching ◦ skin rash, hives, redness, or swelling outside of the injection site area ◦ dizziness or fainting ◦ fast heartbeat or pounding in your chest (tachycardia) ◦ sweating risk of infection with live vaccines. You should not get live vaccines if you are receiving ILARIS. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 7d271f3b-e4f9-4d80-8dcf-28d49123f80e), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>10%) are nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight increased, musculoskeletal pain, and vertigo.
Table 1: Adverse Reactions in ≥ 10% of Patients in Parts 1 to 3 of the Phase 3 Trial for Patients with CAPS
| Adverse reactions | ILARIS N = 35 n (%) |
|---|---|
| n (%) of patients with adverse reactions | 35 (100) |
| Nasopharyngitis | 12 (34) |
| Diarrhea | 7 (20) |
| Influenza | 6 (17) |
| Rhinitis | 6 (17) |
| Nausea | 5 (14) |
| Headache | 5 (14) |
| Bronchitis | 4 (11) |
| Gastroenteritis | 4 (11) |
| Pharyngitis | 4 (11) |
| Weight increased | 4 (11) |
| Musculoskeletal pain | 4 (11) |
| Vertigo | 4 (11) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions (5.1)] Immunosuppression [see Warnings and Precautions (5.2)] Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Macrophage Activation Syndrome [see Warnings and Precautions (5.5)] CAPS: The most common adverse reactions (>10%) are nasopharyngitis, diarrhea, influenza, rhinitis, nausea, headache, bronchitis, gastroenteritis, pharyngitis, weight increased, musculoskeletal pain, and vertigo. ( 6 ) TRAPS, HIDS/MKD, and FMF: The most common adverse reactions (≥10%) are injection-site reactions and nasopharyngitis. ( 6 ) Still’s Disease: The most common adverse drug reactions (>10%) are infections (nasopharyngitis and upper respiratory tract infections), abdominal pain, and injection-site reactions. ( 6 ) Gout Flares: The most common adverse reactions (>2%) reported by are nasopharyngitis, upper respiratory tract infections, urinary tract infections, hypertriglyceridemia, and back pain. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, 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?
10,756 reports list canakinumab among the medicines taken, 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. Of the 18 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Canakinumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions