Anakinra side effects: what 16,488 FDA adverse event reports show

Anakinra · Kineret · 1,097 reaction terms · 102,833 drug–reaction co-reports · data 2026-09-14

Drug class

Interleukin-1 Receptor Antagonist

FDA label (Established Pharmacologic Class)

Brand names

Kineret

openFDA label

Who reports

16,488 reports · 69% serious · 1,515 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis (RA) Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age.

FDA label, Indications and Usage

What it is

KINERET (anakinra) is a recombinant , nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). KINERET differs from native human IL-1Ra in that it has the addition of a single methionine residue at its amino terminus.

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) 1Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 8Not in label — unassessed 25

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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,057 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Human antichimeric antibody positive	302	11,473.4 8,012.5–16,429.1ROR 11,687.4 · calibrated p 1e-30 ✓	1,054.8 EB05 958.7 · IC025 +8.4 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Monocyte chemotactic protein-1 increased	30	7,522.3 2,918.9–19,385.3ROR 7,536.0 · calibrated p 7e-21 ✓	636.2 EB05 467.1 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Infiltration anaesthesia	22	2,758.2 1,306.3–5,823.6ROR 2,761.8 · calibrated p 2e-18 ✓	491.8 EB05 342.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Actinomycotic sepsis	17	2,664.1 1,149.9–6,172.4ROR 2,666.9 · calibrated p 3e-17 ✓	434.4 EB05 287.3 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Human anti-human antibody test	16	1,823.6 846.4–3,928.8ROR 1,825.3 · calibrated p 3e-16 ✓	393.1 EB05 256.5 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Body height below normal	311	1,178.0 1,009.8–1,374.1ROR 1,200.6 · calibrated p 4e-18 ✓	585.8 EB05 533.1 · IC025 +8.1 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Febrile infection-related epilepsy syndrome	11	725.8 345.5–1,525.0ROR 726.3 · calibrated p 1e-12 ✓	255.9 EB05 152.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Alpha tumour necrosis factor increased	30	597.0 386.6–921.9ROR 598.1 · calibrated p 1e-13 ✓	321.7 EB05 236.2 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Serum amyloid a protein increased	46	534.0 378.3–753.8ROR 535.5 · calibrated p 1e-13 ✓	324.2 EB05 252.9 · IC025 +5.7 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Ankle arthroplasty	95	459.9 363.7–581.4ROR 462.5 · calibrated p 3e-13 ✓	315.3 EB05 265.6 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Autoinflammatory disease	54	451.3 330.8–615.8ROR 452.8 · calibrated p 5e-13 ✓	297.2 EB05 236.4 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	not fetched	no trial data cached
Tumour necrosis factor receptor-associated periodic syndrome	15	417.9 233.0–749.5ROR 418.3 · calibrated p 2e-11 ✓	224.3 EB05 144.3 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	not fetched	no trial data cached
Short stature	59	371.7 278.1–496.8ROR 373.0 · calibrated p 3e-12 ✓	262.5 EB05 211.0 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Intestinal sepsis	50	313.4 230.0–427.1ROR 314.4 · calibrated p 2e-11 ✓	229.0 EB05 180.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Red blood cell sedimentation rate abnormal	421	281.3 253.4–312.4ROR 288.7 · calibrated p 2e-11 ✓	227.6 EB05 209.9 · IC025 +7.3 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Joint destruction	254	246.9 216.0–282.2ROR 250.7 · calibrated p 6e-11 ✓	203.3 EB05 183.1 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Skin graft infection	10	241.1 122.6–474.3ROR 241.2 · calibrated p 4e-9 ✓	146.5 EB05 85.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Propionibacterium infection	17	236.8 141.1–397.6ROR 237.1 · calibrated p 1e-9 ✓	163.2 EB05 107.9 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Juvenile idiopathic arthritis	371	227.2 203.6–253.5ROR 232.4 · calibrated p 1e-10 ✓	190.6 EB05 174.9 · IC025 +7.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	not fetched	no trial data cached
Antibody test positive	235	207.0 180.5–237.5ROR 210.0 · calibrated p 3e-10 ✓	175.3 EB05 157.3 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Immune effector cell-associated haematotoxicity	18	201.5 122.5–331.4ROR 201.7 · calibrated p 3e-9 ✓	147.0 EB05 98.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Hair follicle tumour benign	15	195.9 113.7–337.5ROR 196.1 · calibrated p 6e-9 ✓	139.8 EB05 89.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Interleukin level increased	70	192.0 149.4–246.8ROR 192.8 · calibrated p 1e-9 ✓	159.5 EB05 130.5 · IC025 +5.9 3/3 methods agree	Likely indication confounding term in indications	not fetched	no trial data cached
Hepatosplenic t-cell lymphoma	48	188.1 138.9–254.6ROR 188.6 · calibrated p 2e-9 ✓	153.8 EB05 120.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Bone density increased	49	177.5 131.7–239.4ROR 178.1 · calibrated p 2e-9 ✓	146.8 EB05 115.5 · IC025 +5.5 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Vexas syndrome	11	176.8 94.1–332.3ROR 176.9 · calibrated p 3e-8 ✓	122.6 EB05 73.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Herpes zoster infection neurological	19	170.1 105.4–274.7ROR 170.3 · calibrated p 1e-8 ✓	130.6 EB05 88.3 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Cryopyrin associated periodic syndrome	20	145.8 91.8–231.6ROR 146.0 · calibrated p 3e-8 ✓	116.4 EB05 79.6 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications	not fetched	no trial data cached
Body tinea	58	145.7 111.1–191.2ROR 146.2 · calibrated p 1e-8 ✓	125.3 EB05 100.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Pneumonia lipoid	13	139.3 78.6–247.0ROR 139.4 · calibrated p 9e-8 ✓	106.3 EB05 66.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Hyperferritinaemia	40	135.9 98.1–188.3ROR 136.2 · calibrated p 2e-8 ✓	116.0 EB05 88.9 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Soft tissue disorder	106	133.2 109.1–162.6ROR 134.0 · calibrated p 2e-8 ✓	118.0 EB05 100.3 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Polyarthritis	490	130.9 119.4–143.5ROR 134.8 · calibrated p 1e-8 ✓	118.1 EB05 109.5 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Apparent death	322	123.0 109.8–137.7ROR 125.4 · calibrated p 2e-8 ✓	111.3 EB05 101.5 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Testicular seminoma (pure)	10	121.7 63.6–232.9ROR 121.8 · calibrated p 4e-7 ✓	92.1 EB05 53.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Haemophagocytic lymphohistiocytosis	631	121.7 112.3–131.9ROR 126.5 · calibrated p 2e-8 ✓	110.7 EB05 103.6 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Drug specific antibody	119	121.5 100.7–146.6ROR 122.4 · calibrated p 3e-8 ✓	108.9 EB05 93.5 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	not fetched	no trial data cached
Growth failure	30	120.5 82.9–175.3ROR 120.8 · calibrated p 7e-8 ✓	103.0 EB05 75.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Clubbing	34	114.9 80.9–163.2ROR 115.1 · calibrated p 9e-8 ✓	99.6 EB05 74.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Diaphragm muscle weakness	13	114.8 65.1–202.5ROR 114.9 · calibrated p 3e-7 ✓	91.5 EB05 56.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	not fetched	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
Off label use (used outside approved label)	5,160	7.6 7.4–7.8ROR 10.6 · calibrated p 0.026 ✓	7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Drug ineffective (drug did not work)	4,243	4.1 4.0–4.2ROR 5.2 · calibrated p 0.215	4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Condition aggravated	1,689	7.1 6.8–7.5ROR 7.8 · calibrated p 0.071	7.1 EB05 6.8 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Pain	1,587	3.3 3.1–3.4ROR 3.5 · calibrated p 0.478	3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Rheumatoid arthritis	1,549	17.6 16.8–18.5ROR 19.4 · calibrated p 0.002 ✓	17.4 EB05 16.7 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	not fetched	no trial data cached
Arthralgia (joint pain)	1,198	3.7 3.5–3.9ROR 3.9 · calibrated p 0.398	3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Joint swelling	1,190	12.7 12.0–13.4ROR 13.6 · calibrated p 0.010 ✓	12.6 EB05 12.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	not fetched	no trial data cached
Drug intolerance	1,167	15.6 14.8–16.5ROR 16.7 · calibrated p 0.004 ✓	15.4 EB05 14.7 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Pyrexia (fever)	1,164	4.3 4.1–4.5ROR 4.5 · calibrated p 0.292	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Injection site pain (pain where injected)	1,026	4.3 4.1–4.6ROR 4.5 · calibrated p 0.293	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Rash	978	2.9 2.7–3.1ROR 3.0 · calibrated p 0.630	2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Nausea	956	1.5 1.4–1.6ROR 1.6 · calibrated p 0.690	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	not fetched	no trial data cached
Product dose omission issue	917	4.1 3.9–4.4ROR 4.3 · calibrated p 0.329	4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	not fetched	no trial data cached
Infection	902	8.0 7.5–8.5ROR 8.4 · calibrated p 0.057	7.9 EB05 7.5 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	not fetched	no trial data cached
Vomiting	877	2.4 2.2–2.5ROR 2.5 · calibrated p 0.831	2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	not fetched	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.

Infiltration anaesthesia — n=22, PRR 2,758.2
Ankle arthroplasty — n=95, PRR 459.9
Short stature — n=59, PRR 371.7
Intestinal sepsis — n=50, PRR 313.4
Joint destruction — n=254, PRR 246.9
Hepatosplenic t-cell lymphoma — n=48, PRR 188.1
Body tinea — n=58, PRR 145.7
Hyperferritinaemia — n=40, PRR 135.9
Soft tissue disorder — n=106, PRR 133.2
Polyarthritis — n=490, PRR 130.9

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 Anakinra?

In FDA FAERS, the most frequently co-reported reaction terms for Anakinra are pain, rheumatoid arthritis, arthralgia, joint swelling, pyrexia, injection site pain. 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 Anakinra have an FDA boxed warning?

No. The FDA label retrieved for Anakinra has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Anakinra 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 d9d74915-6606-4570-9c52-c4001d3177de, effective 20260403; matched on openfda.generic_name.exact:"ANAKINRA")
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, field patient.drug.openfda.generic_name.exact, 1,097 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-14. 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.