Drug · FAERS side-effect profile with label screen
Canakinumab side effects: what 10,752 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Ilaris
openFDA label
Who reports
10,752 reports · 47% serious · 470 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ILARIS 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 Synd.
FDA label, Indications and Usage
What it is
Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 3Likely indication confounding 7Lab value / disease marker 2Not in label — unassessed 28
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 966 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Familial cold autoinflammatory syndrome | 16 | 15,382.6 3,537.3–66,894.5ROR 15,405.5 · χ² 25,660 / p <1e-300 | 559.4 EB05 365.1 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications | serious n=14 | no trial data cached |
| Muckle-wells syndrome | 39 | 8,332.3 4,037.3–17,196.3ROR 8,362.6 · χ² 59,362 / p <1e-300 | 881.5 EB05 672.8 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications | serious n=34 | no trial data cached |
| X-linked lymphoproliferative syndrome | 24 | 5,127.5 2,383.9–11,028.6ROR 5,139.0 · χ² 32,165 / p <1e-300 | 659.0 EB05 466.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 58%) | no trial data cached |
| Actinomycotic sepsis | 17 | 4,086.0 1,763.7–9,465.9ROR 4,092.5 · χ² 20,928 / p <1e-300 | 527.5 EB05 348.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Chronic infantile neurological cutaneous and articular syndrome | 13 | 3,571.0 1,425.0–8,948.7ROR 3,575.3 · χ² 15,013 / p <1e-300 | 439.2 EB05 273.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Cryopyrin associated periodic syndrome | 106 | 2,370.0 1,784.4–3,147.8ROR 2,393.6 · χ² 111,372 / p <1e-300 | 890.0 EB05 756.7 · IC025 +7.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=104 | no trial data cached |
| Tumour necrosis factor receptor-associated periodic syndrome | 27 | 1,573.2 946.4–2,615.3ROR 1,577.2 · χ² 22,476 / p <1e-300 | 535.4 EB05 386.4 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=24 | no trial data cached |
| Familial mediterranean fever | 81 | 1,403.1 1,054.3–1,867.3ROR 1,413.8 · χ² 64,805 / p <1e-300 | 680.3 EB05 564.8 · IC025 +6.7 3/3 methods agree | Likely indication confounding term in indications | serious n=73 | no trial data cached |
| Chemokine increased | 11 | 1,321.9 613.6–2,847.8ROR 1,323.3 · χ² 7,839 / p <1e-300 | 331.5 EB05 197.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Serum amyloid a protein increased | 53 | 1,009.0 724.0–1,406.2ROR 1,014.0 · χ² 34,345 / p <1e-300 | 533.8 EB05 423.7 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=53 | no trial data cached |
| Autoinflammatory disease | 45 | 544.2 391.1–757.3ROR 546.5 · χ² 18,596 / p <1e-300 | 359.4 EB05 279.6 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=36 | no trial data cached |
| Intestinal sepsis | 49 | 468.7 343.2–640.2ROR 470.9 · χ² 18,014 / p <1e-300 | 328.6 EB05 258.4 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=49 · ♀ 0% (drug 58%) | no trial data cached |
| Short stature | 50 | 462.2 339.6–629.0ROR 464.4 · χ² 18,182 / p <1e-300 | 326.2 EB05 257.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=50 · 94% clinician | no trial data cached |
| Interleukin level increased | 60 | 247.0 188.9–323.0ROR 248.4 · χ² 12,812 / p <1e-300 | 204.8 EB05 164.9 · IC025 +5.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=41 · 97% clinician | no trial data cached |
| Spinal instability | 26 | 228.3 152.1–342.6ROR 228.8 · χ² 5,058 / p <1e-300 | 177.7 EB05 127.4 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 58%) | no trial data cached |
| Herpes zoster infection neurological | 16 | 215.1 128.4–360.6ROR 215.5 · χ² 2,878 / p <1e-300 | 157.6 EB05 102.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Atlantoaxial instability | 10 | 192.3 100.4–368.2ROR 192.5 · χ² 1,560 / p <1e-300 | 131.6 EB05 76.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Apparent death | 324 | 189.9 169.7–212.5ROR 195.7 · χ² 55,241 / p <1e-300 | 171.2 EB05 156.1 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=324 · ♀ 1% (drug 58%) | no trial data cached |
| Clubbing | 33 | 170.6 119.5–243.4ROR 171.1 · χ² 4,955 / p <1e-300 | 143.9 EB05 107.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 81% (drug 58%) · 97% clinician | no trial data cached |
| Secondary amyloidosis | 12 | 168.4 93.4–303.8ROR 168.6 · χ² 1,686 / p <1e-300 | 124.7 EB05 76.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pneumonia lipoid | 10 | 160.2 84.1–305.4ROR 160.4 · χ² 1,317 / p 1e-288 | 115.9 EB05 67.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hypertensive cardiomyopathy | 19 | 140.5 88.2–223.8ROR 140.8 · χ² 2,324 / p <1e-300 | 116.0 EB05 78.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Juvenile idiopathic arthritis | 154 | 130.8 111.2–153.8ROR 132.7 · χ² 18,453 / p <1e-300 | 120.7 EB05 105.5 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications | serious n=151 | no trial data cached |
| Epidural lipomatosis | 19 | 112.4 70.8–178.5ROR 112.6 · χ² 1,878 / p <1e-300 | 96.2 EB05 65.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Hyperferritinaemia | 19 | 93.7 59.1–148.4ROR 93.8 · χ² 1,574 / p <1e-300 | 82.2 EB05 55.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Muscle abscess | 27 | 88.3 60.1–129.8ROR 88.5 · χ² 2,145 / p <1e-300 | 79.9 EB05 57.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 58%) | no trial data cached |
| Congenital aplasia | 12 | 84.2 47.3–150.1ROR 84.3 · χ² 867 / p 7e-191 | 71.9 EB05 43.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cellulitis staphylococcal | 24 | 74.3 49.5–111.7ROR 74.5 · χ² 1,601 / p <1e-300 | 67.9 EB05 48.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=23 · 100% clinician | no trial data cached |
| Haemophagocytic lymphohistiocytosis | 261 | 73.1 64.7–82.5ROR 74.8 · χ² 17,806 / p <1e-300 | 70.1 EB05 63.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 85.6 | no trial data cached |
| Joint arthroplasty | 60 | 67.4 52.2–87.2ROR 67.8 · χ² 3,730 / p <1e-300 | 63.9 EB05 51.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=60 · ♀ 0% (drug 58%) | no trial data cached |
| Growth failure | 11 | 63.9 35.1–116.5ROR 64.0 · χ² 600 / p 1e-132 | 56.2 EB05 33.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Steroid dependence | 26 | 61.5 41.6–90.8ROR 61.6 · χ² 1,441 / p <1e-300 | 57.2 EB05 41.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | no trial data cached |
| Focal nodular hyperplasia | 16 | 61.0 37.1–100.4ROR 61.1 · χ² 859 / p 5e-189 | 55.5 EB05 36.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Growth retardation | 86 | 58.3 47.1–72.2ROR 58.8 · χ² 4,647 / p <1e-300 | 56.0 EB05 46.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=86 · 90% clinician | no trial data cached |
| Secondary adrenocortical insufficiency | 42 | 56.3 41.4–76.4ROR 56.5 · χ² 2,162 / p <1e-300 | 53.5 EB05 41.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 35% (drug 58%) | no trial data cached |
| C-reactive protein abnormal | 165 | 51.5 44.2–60.1ROR 52.3 · χ² 7,913 / p <1e-300 | 49.9 EB05 43.8 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=164 · ♀ 6% (drug 58%) | no trial data cached |
| Pneumonia streptococcal | 28 | 51.0 35.0–74.2ROR 51.1 · χ² 1,288 / p 2e-282 | 48.2 EB05 35.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 0% (drug 58%) | no trial data cached |
| Histiocytosis haematophagic | 74 | 49.1 39.0–61.8ROR 49.4 · χ² 3,353 / p <1e-300 | 47.3 EB05 39.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=74 | no trial data cached |
| Alveolar proteinosis | 14 | 47.7 28.1–81.1ROR 47.8 · χ² 580 / p 2e-128 | 44.0 EB05 27.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cushingoid | 76 | 47.0 37.4–58.9ROR 47.3 · χ² 3,293 / p <1e-300 | 45.4 EB05 37.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=75 · 93% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 1,431 | 8.1 7.7–8.5ROR 9.2 · χ² 8,993 / p <1e-300 | 8.0 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 | no trial data cached |
| Inappropriate schedule of drug administration | 1,242 | 34.1 32.4–36.0ROR 38.5 · χ² 39,349 / p <1e-300 | 33.5 EB05 32.0 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · 89% consumer | no trial data cached |
| Drug ineffective (drug did not work) | 1,212 | 1.8 1.7–1.9ROR 1.9 · χ² 454 / p 4e-101 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Inappropriate schedule of product administration | 960 | 10.6 10.0–11.3ROR 11.6 · χ² 8,398 / p <1e-300 | 10.6 EB05 10.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 7.2 | no trial data cached |
| Pain | 941 | 3.0 2.8–3.2ROR 3.2 · χ² 1,275 / p 1e-279 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Condition aggravated | 867 | 5.6 5.3–6.0ROR 6.0 · χ² 3,319 / p <1e-300 | 5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Malaise (feeling unwell) | 727 | 3.2 3.0–3.5ROR 3.4 · χ² 1,138 / p 1e-249 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Off label use (used outside approved label) | 715 | 1.6 1.5–1.7ROR 1.6 · χ² 170 / p 4e-39 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.4 · ♀ 34% (drug 58%) | no trial data cached |
| Arthralgia (joint pain) | 611 | 2.9 2.7–3.1ROR 3.0 · χ² 761 / p 1e-167 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Rash | 564 | 2.5 2.3–2.8ROR 2.6 · χ² 534 / p 2e-118 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Incorrect dose administered | 504 | 4.4 4.0–4.8ROR 4.5 · χ² 1,321 / p 2e-289 | 4.4 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Joint swelling | 490 | 8.0 7.3–8.7ROR 8.3 · χ² 2,979 / p <1e-300 | 7.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 18% (drug 58%) | no trial data cached |
| Headache | 441 | 1.4 1.3–1.5ROR 1.4 · χ² 46 / p 7e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Fatigue (tiredness) | 393 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.400 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 389 | 8.0 7.2–8.8ROR 8.2 · χ² 2,366 / p <1e-300 | 7.9 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 5% (drug 58%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- X-linked lymphoproliferative syndrome — n=24, PRR 5,127.5
- Short stature — n=50, PRR 462.2
- Spinal instability — n=26, PRR 228.3
- Apparent death — n=324, PRR 189.9
- Clubbing — n=33, PRR 170.6
- Muscle abscess — n=27, PRR 88.3
- Cellulitis staphylococcal — n=24, PRR 74.3
- Haemophagocytic lymphohistiocytosis — n=261, PRR 73.1
- Joint arthroplasty — n=60, PRR 67.4
- Steroid dependence — n=26, PRR 61.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Canakinumab?
In FDA FAERS, the most frequently co-reported reaction terms for Canakinumab are pyrexia, pain, malaise, arthralgia, rash, joint swelling. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Canakinumab have an FDA boxed warning?
No. The FDA label retrieved for Canakinumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Canakinumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 7d271f3b-e4f9-4d80-8dcf-28d49123f80e, effective 20260608; matched on
openfda.generic_name.exact:"CANAKINUMAB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,006 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.