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Anakinra Side Effects

The most commonly reported side effects of anakinra include off label use, condition aggravated, and pain, based on 15,992 FDA adverse event reports from 2004 to 2025. 25.5% of reports found the drug to be ineffective.

Anakinra side effects

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

1
Off Label Use31.1%4,975
2
Drug Ineffective25.5%4,079
3
Condition Aggravated9.9%1,584
4
Pain9.6%1,537
5
Rheumatoid Arthritis9.3%1,481
6
Joint Swelling7.3%1,170
7
Drug Intolerance7.2%1,158
8
Arthralgia7.1%1,140
9
Pyrexia6.6%1,054
10
Rash5.7%908
11
Nausea5.6%902
12
Injection Site Pain5.6%900
13
Product Dose Omission Issue5.6%890
14
Infection5.4%867
15
Drug Hypersensitivity5.3%851

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

Report severity

69.5%Serious11,113 reports
31.6%Hospitalizations5,061 reports
9.1%Fatal1,448 reports

Seriousness is determined by the reporter, not by OpenClaim.

Anakinra drug interactions

Other drugs that appear in adverse event reports alongside anakinra. 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
Methotrexate22.2%3,553
2
Etanercept21.2%3,395
3
Tocilizumab20.8%3,329
4
Infliximab18.5%2,956
5
Adalimumab17.7%2,826
6
Hydroxychloroquine-sulfate17.0%2,720
7
Abatacept15.7%2,516
8
Rituximab14.1%2,250
9
Leflunomide13.6%2,173
10
Sulfasalazine9.4%1,503
11
Prednisone8.9%1,429
12
Golimumab5.6%903
13
Cyclosporine5.3%844
14
Tofacitinib5.2%837
15
Canakinumab5.2%824

Taken alongside

1
Prednisone9.8%1,566
2
Methotrexate7.4%1,179
3
Tofacitinib4.0%639
4
Tocilizumab3.9%628
5
Acetaminophen3.9%617
6
Hydroxychloroquine-sulfate3.8%614
7
Methylprednisolone3.8%600
8
Dexamethasone3.2%511
9
Folic-acid3.2%505
10
Pantoprazole-sodium3.0%481
11
Cyclosporine2.7%434
12
Leflunomide2.7%430
13
Rituximab2.6%420
14
Furosemide2.4%382
15
Levothyroxine-sodium2.3%368

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 anakinra side effects

60.3% of anakinra adverse event reports involve female patients and 31.7% involve male patients. The largest age group is adult at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.3%
Male31.7%
Unknown8.0%

Age group

< 23.8%
2–1114.7%
12–177.4%
18–6456.9%
65+17.1%

What is anakinra used for

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

AcneAcquired AminoaciduriaAcute Disseminated EncephalomyelitisAcute Febrile Neutrophilic DermatosisAcute Kidney InjuryAcute Lung InjuryAcute Myeloid LeukaemiaAcute Myocardial InfarctionAcute Respiratory Distress SyndromeAdrenocortical Insufficiency AcuteAlpha Tumour Necrosis FactorAmyloidosisAmyotrophic Lateral SclerosisAnaemiaAnkylosing Spondylitis

Showing 15 of 691 indications

Anakinra brand names and reporting trend

Anakinra is sold under the brand name Kineret.

Brand names

Kineret10,763

Quarterly reports (20042025)

20052010201520202025

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

Taking anakinra with another medication?

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