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Canakinumab Side Effects

The most commonly reported side effects of canakinumab include pyrexia, inappropriate schedule of drug administration, and inappropriate schedule of product administration, based on 10,581 FDA adverse event reports from 2010 to 2025. 11.1% of reports found the drug to be ineffective.

Canakinumab side effects

Percentages show how often each reaction appears relative to total reports for canakinumab.

1
Pyrexia13.1%1,382
2
Inappropriate Schedule Of Drug Administration11.7%1,242
3
Drug Ineffective11.1%1,172
4
Inappropriate Schedule Of Product Administration9.0%953
5
Pain8.8%929
6
Condition Aggravated7.9%836
7
Malaise6.7%708
8
Off Label Use6.4%681
9
Arthralgia5.6%589
10
Rash5.1%543
11
Incorrect Dose Administered4.7%500
12
Joint Swelling4.6%488
13
Headache4.0%421
14
Pulmonary Embolism3.7%388
15
Diverticulitis3.6%381

These are voluntary reports and do not establish that canakinumab caused these reactions.

Report severity

46.6%Serious4,934 reports
22.3%Hospitalizations2,361 reports
4.4%Fatal463 reports

Seriousness is determined by the reporter, not by OpenClaim.

Canakinumab drug interactions

Other drugs that appear in adverse event reports alongside canakinumab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tocilizumab7.4%782
2
Anakinra7.2%766
3
Methotrexate6.9%727
4
Infliximab5.3%559
5
Adalimumab5.0%529
6
Etanercept4.7%498
7
Rituximab4.6%490
8
Abatacept4.0%427
9
Leflunomide3.8%400
10
Sulfasalazine3.7%387
11
Hydroxychloroquine-sulfate3.4%359
12
Cyclosporine2.6%276
13
Tofacitinib2.2%236
14
Prednisone2.0%208
15
Prednisolone1.8%186

Taken alongside

1
Prednisone4.4%470
2
Anakinra3.0%316
3
Methotrexate2.8%301
4
Colchicine2.7%284
5
Prednisolone2.4%253
6
Acetaminophen2.1%226
7
Tocilizumab1.7%184
8
Methylprednisolone1.7%175
9
Pregabalin1.6%170
10
Aspirin1.5%158
11
Folic-acid1.5%154
12
Ergocalciferol1.2%132
13
Cyclosporine1.2%130
14
Omeprazole1.2%124
15
Atorvastatin-calcium1.1%121

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports canakinumab side effects

50.7% of canakinumab adverse event reports involve female patients and 37.5% involve male patients. The largest age group is adult at 41%. These figures reflect who reports side effects, not underlying risk.

Sex

Female50.7%
Male37.5%
Unknown11.8%

Age group

< 22.4%
2–1131.7%
12–1715.1%
18–6441.3%
65+9.5%

What is canakinumab used for

Conditions and purposes for which patients were taking canakinumab when the adverse event was reported.

Acquired Immunodeficiency SyndromeAcromegalyAcute Febrile Neutrophilic DermatosisAlveolar ProteinosisAmyloidosisAnkylosing SpondylitisAntiinflammatory TherapyAntiphospholipid SyndromeArrhythmiaArteriosclerosisArthralgiaArthritisArthropathyAsthmaAtrial Fibrillation

Showing 15 of 318 indications

Canakinumab brand names and reporting trend

Canakinumab is sold under the brand name Ilaris.

Brand names

Ilaris1,650

Quarterly reports (20102025)

201020122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking canakinumab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.