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Drug · FAERS side-effect profile with label screen

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
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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

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. 1,057 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Human antichimeric antibody positive30211,473.4
8,012.5–16,429.1ROR 11,687.4 · χ² 340,140 / p <1e-300
1,054.8 EB05 958.7 · IC025 +8.4
3/3 methods agree
Lab value / disease markerserious n=302 · ♀ 100% (drug 66%)not reported in cached trials
Monocyte chemotactic protein-1 increased307,522.3
2,918.9–19,385.3ROR 7,536.0 · χ² 31,163 / p <1e-300
636.2 EB05 467.1 · IC025 +5.2
3/3 methods agree
Lab value / disease markerserious n=30 · ♀ 0% (drug 66%)not reported in cached trials
Infiltration anaesthesia222,758.2
1,306.3–5,823.6ROR 2,761.8 · χ² 18,096 / p <1e-300
491.8 EB05 342.4 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=22 · ♀ 100% (drug 66%)not reported in cached trials
Actinomycotic sepsis172,664.1
1,149.9–6,172.4ROR 2,666.9 · χ² 13,642 / p <1e-300
434.4 EB05 287.3 · IC025 +4.3
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Human anti-human antibody test161,823.6
846.4–3,928.8ROR 1,825.3 · χ² 11,143 / p <1e-300
393.1 EB05 256.5 · IC025 +4.1
3/3 methods agree
Reporting / coding artifactserious n=16not reported in cached trials
Body height below normal3111,178.0
1,009.8–1,374.1ROR 1,200.6 · χ² 187,957 / p <1e-300
585.8 EB05 533.1 · IC025 +8.1
3/3 methods agree
Reporting / coding artifactserious n=311 · ♀ 100% (drug 66%)not reported in cached trials
Febrile infection-related epilepsy syndrome11725.8
345.5–1,525.0ROR 726.3 · χ² 4,594 / p <1e-300
255.9 EB05 152.5 · IC025 +3.4
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Alpha tumour necrosis factor increased30597.0
386.6–921.9ROR 598.1 · χ² 11,691 / p <1e-300
321.7 EB05 236.2 · IC025 +5.1
3/3 methods agree
Lab value / disease markerserious n=30 · ♀ 0% (drug 66%)not reported in cached trials
Serum amyloid a protein increased46534.0
378.3–753.8ROR 535.5 · χ² 16,790 / p <1e-300
324.2 EB05 252.9 · IC025 +5.7
3/3 methods agree
Lab value / disease markerserious n=46not reported in cached trials
Ankle arthroplasty95459.9
363.7–581.4ROR 462.5 · χ² 31,489 / p <1e-300
315.3 EB05 265.6 · IC025 +6.6
3/3 methods agree
Not in label — unassessedserious n=95 · ♀ 100% (drug 66%) · 95% cliniciannot reported in cached trials
Tumour necrosis factor receptor-associated periodic syndrome15417.9
233.0–749.5ROR 418.3 · χ² 4,371 / p <1e-300
224.3 EB05 144.3 · IC025 +4.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=14not reported in cached trials
Short stature59371.7
278.1–496.8ROR 373.0 · χ² 16,540 / p <1e-300
262.5 EB05 211.0 · IC025 +6.0
3/3 methods agree
Not in label — unassessedserious n=59 · ♀ 100% (drug 66%)not reported in cached trials
Intestinal sepsis50313.4
230.0–427.1ROR 314.4 · χ² 12,208 / p <1e-300
229.0 EB05 180.5 · IC025 +5.7
3/3 methods agree
Not in label — unassessedserious n=50 · ♀ 0% (drug 66%)not reported in cached trials
Red blood cell sedimentation rate abnormal421281.3
253.4–312.4ROR 288.7 · χ² 95,834 / p <1e-300
227.6 EB05 209.9 · IC025 +7.3
3/3 methods agree
Lab value / disease markerserious n=417 · ♀ 95% (drug 66%)not reported in cached trials
Joint destruction254246.9
216.0–282.2ROR 250.7 · χ² 51,761 / p <1e-300
203.3 EB05 183.1 · IC025 +7.0
3/3 methods agree
Not in label — unassessedserious n=254 · ♀ 100% (drug 66%) · 93% cliniciannot reported in cached trials
Skin graft infection10241.1
122.6–474.3ROR 241.2 · χ² 1,809 / p <1e-300
146.5 EB05 85.0 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Propionibacterium infection17236.8
141.1–397.6ROR 237.1 · χ² 3,162 / p <1e-300
163.2 EB05 107.9 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=17not reported in cached trials
Juvenile idiopathic arthritis371227.2
203.6–253.5ROR 232.4 · χ² 70,556 / p <1e-300
190.6 EB05 174.9 · IC025 +7.1
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=370not reported in cached trials
Antibody test positive235207.0
180.5–237.5ROR 210.0 · χ² 41,183 / p <1e-300
175.3 EB05 157.3 · IC025 +6.8
3/3 methods agree
Lab value / disease markerserious n=235 · ♀ 97% (drug 66%)not reported in cached trials
Immune effector cell-associated haematotoxicity18201.5
122.5–331.4ROR 201.7 · χ² 2,923 / p <1e-300
147.0 EB05 98.4 · IC025 +4.1
3/3 methods agree
Not in label — unassessedserious n=18not reported in cached trials
Hair follicle tumour benign15195.9
113.7–337.5ROR 196.1 · χ² 2,350 / p <1e-300
139.8 EB05 89.9 · IC025 +3.8
3/3 methods agree
Not in label — unassessedserious n=15not reported in cached trials
Interleukin level increased70192.0
149.4–246.8ROR 192.8 · χ² 11,371 / p <1e-300
159.5 EB05 130.5 · IC025 +5.9
3/3 methods agree
Likely indication confounding
term in indications
serious n=53 · ♀ 28% (drug 66%)not reported in cached trials
Hepatosplenic t-cell lymphoma48188.1
138.9–254.6ROR 188.6 · χ² 7,604 / p <1e-300
153.8 EB05 120.6 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious n=48 · ♀ 100% (drug 66%)not reported in cached trials
Bone density increased49177.5
131.7–239.4ROR 178.1 · χ² 7,381 / p <1e-300
146.8 EB05 115.5 · IC025 +5.5
3/3 methods agree
Lab value / disease markerserious n=49 · ♀ 100% (drug 66%)not reported in cached trials
Vexas syndrome11176.8
94.1–332.3ROR 176.9 · χ² 1,535 / p <1e-300
122.6 EB05 73.1 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=11not reported in cached trials
Herpes zoster infection neurological19170.1
105.4–274.7ROR 170.3 · χ² 2,666 / p <1e-300
130.6 EB05 88.3 · IC025 +4.2
3/3 methods agree
Not in label — unassessedserious n=19not reported in cached trials
Cryopyrin associated periodic syndrome20145.8
91.8–231.6ROR 146.0 · χ² 2,448 / p <1e-300
116.4 EB05 79.6 · IC025 +4.2
3/3 methods agree
Likely indication confounding
term in indications
serious n=20 · 70% consumernot reported in cached trials
Body tinea58145.7
111.1–191.2ROR 146.2 · χ² 7,339 / p <1e-300
125.3 EB05 100.5 · IC025 +5.5
3/3 methods agree
Not in label — unassessedserious n=56 · ♀ 100% (drug 66%)not reported in cached trials
Pneumonia lipoid13139.3
78.6–247.0ROR 139.4 · χ² 1,484 / p <1e-300
106.3 EB05 66.1 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials
Hyperferritinaemia40135.9
98.1–188.3ROR 136.2 · χ² 4,712 / p <1e-300
116.0 EB05 88.9 · IC025 +5.1
3/3 methods agree
Not in label — unassessedserious n=40 · ♀ 45% (drug 66%)not reported in cached trials
Soft tissue disorder106133.2
109.1–162.6ROR 134.0 · χ² 12,450 / p <1e-300
118.0 EB05 100.3 · IC025 +5.9
3/3 methods agree
Not in label — unassessedserious n=106 · ♀ 100% (drug 66%)NCT04330638: 2/36 (5.6%) on Anakinra
Polyarthritis490130.9
119.4–143.5ROR 134.8 · χ² 57,079 / p <1e-300
118.1 EB05 109.5 · IC025 +6.6
3/3 methods agree
Not in label — unassessedserious n=490 · ♀ 96% (drug 66%)not reported in cached trials
Apparent death322123.0
109.8–137.7ROR 125.4 · χ² 35,369 / p <1e-300
111.3 EB05 101.5 · IC025 +6.4
3/3 methods agree
Not in label — unassessedserious n=322 · ♀ 0% (drug 66%)not reported in cached trials
Testicular seminoma (pure)10121.7
63.6–232.9ROR 121.8 · χ² 984 / p 3e-216
92.1 EB05 53.5 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=10not reported in cached trials
Haemophagocytic lymphohistiocytosis631121.7
112.3–131.9ROR 126.5 · χ² 68,769 / p <1e-300
110.7 EB05 103.6 · IC025 +6.5
3/3 methods agree
Not in label — unassessedserious PRR 92.3 · 92% cliniciannot reported in cached trials
Drug specific antibody119121.5
100.7–146.6ROR 122.4 · χ² 12,855 / p <1e-300
108.9 EB05 93.5 · IC025 +5.9
3/3 methods agree
Lab value / disease markerserious n=119 · ♀ 100% (drug 66%)not reported in cached trials
Growth failure30120.5
82.9–175.3ROR 120.8 · χ² 3,137 / p <1e-300
103.0 EB05 75.6 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=30 · ♀ 100% (drug 66%) · 100% cliniciannot reported in cached trials
Clubbing34114.9
80.9–163.2ROR 115.1 · χ² 3,413 / p <1e-300
99.6 EB05 74.5 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious n=34 · 91% cliniciannot reported in cached trials
Diaphragm muscle weakness13114.8
65.1–202.5ROR 114.9 · χ² 1,241 / p 4e-272
91.5 EB05 56.9 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=13not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Anakinra as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Off label use (used outside approved label)5,1607.6
7.4–7.8ROR 10.6 · χ² 30,658 / p <1e-300
7.6 EB05 7.4 · IC025 +2.9
3/3 methods agree
Reporting / coding artifactserious PRR 8.4not reported in cached trials
Drug ineffective (drug did not work)4,2434.1
4.0–4.2ROR 5.2 · χ² 10,606 / p <1e-300
4.1 EB05 4.0 · IC025 +2.0
3/3 methods agree
Reporting / coding artifactserious PRR 8.2not reported in cached trials
Condition aggravated1,6897.1
6.8–7.5ROR 7.8 · χ² 9,002 / p <1e-300
7.1 EB05 6.8 · IC025 +2.7
3/3 methods agree
Reporting / coding artifactserious PRR 8.1not reported in cached trials
Pain1,5873.3
3.1–3.4ROR 3.5 · χ² 2,590 / p <1e-300
3.3 EB05 3.1 · IC025 +1.6
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.5NCT04330638: 1/74 (1.4%) on Anakinra (serious AE)
Rheumatoid arthritis1,54917.6
16.8–18.5ROR 19.4 · χ² 24,104 / p <1e-300
17.4 EB05 16.7 · IC025 +4.0
3/3 methods agree
Likely indication confounding
term in indications; also in warnings
serious PRR 17.0not reported in cached trials
Arthralgia (joint pain)1,1983.7
3.5–3.9ROR 3.9 · χ² 2,380 / p <1e-300
3.7 EB05 3.5 · IC025 +1.8
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 4.5 · ♀ 88% (drug 66%)NCT03002974: 2/52 (3.8%) on Anakinra
Joint swelling1,19012.7
12.0–13.4ROR 13.6 · χ² 12,732 / p <1e-300
12.6 EB05 12.0 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious PRR 17.1not reported in cached trials
Drug intolerance1,16715.6
14.8–16.5ROR 16.7 · χ² 15,803 / p <1e-300
15.4 EB05 14.7 · IC025 +3.8
3/3 methods agree
Reporting / coding artifactserious PRR 20.7not reported in cached trials
Pyrexia (fever)1,1644.3
4.1–4.5ROR 4.5 · χ² 2,968 / p <1e-300
4.3 EB05 4.1 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.6NCT03002974: 2/54 (3.7%) on Anakinra
Injection site pain (pain where injected)1,0264.3
4.1–4.6ROR 4.5 · χ² 2,633 / p <1e-300
4.3 EB05 4.1 · IC025 +2.0
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 5.6 · 86% consumerNCT04330638: 1/74 (1.4%) on Anakinra (serious AE)
Rash9782.9
2.7–3.1ROR 3.0 · χ² 1,214 / p 3e-266
2.9 EB05 2.7 · IC025 +1.4
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 3.7NCT04330638: 2/32 (6.2%) on Anakinra
Nausea9561.5
1.4–1.6ROR 1.6 · χ² 188 / p 4e-43
1.5 EB05 1.5 · IC025 +0.5Labeled adverse reaction
exact term
serious PRR 2.0NCT04330638: 2/32 (6.2%) on Anakinra
Product dose omission issue9174.1
3.9–4.4ROR 4.3 · χ² 2,173 / p <1e-300
4.1 EB05 3.9 · IC025 +1.9
3/3 methods agree
Reporting / coding artifactserious PRR 5.5 · 92% consumernot reported in cached trials
Infection9028.0
7.5–8.5ROR 8.4 · χ² 5,519 / p <1e-300
7.9 EB05 7.5 · IC025 +2.9
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 7.0NCT04330638: 1/74 (1.4%) on Anakinra (serious AE)
Vomiting8772.4
2.2–2.5ROR 2.5 · χ² 716 / p 6e-158
2.4 EB05 2.2 · IC025 +1.1
3/3 methods agree
Labeled adverse reaction
exact term
serious PRR 2.7 · ♀ 89% (drug 66%)NCT04330638: 2/36 (5.6%) on Anakinra

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.

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

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.