Anakinra side effects: what 16,488 FDA adverse event reports show
Drug class
Interleukin-1 Receptor Antagonist
Brand names
Kineret
Who reports
16,488 reports · 69% serious · 1,515 with death outcome · 66% female
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.
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.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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 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.
| 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 · χ² 340,140 / p <1e-300 | 1,054.8 EB05 958.7 · IC025 +8.4 3/3 methods agree | Lab value / disease marker | serious n=302 · ♀ 100% (drug 66%) | not reported in cached trials |
| Monocyte chemotactic protein-1 increased | 30 | 7,522.3 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 marker | serious n=30 · ♀ 0% (drug 66%) | not reported in cached trials |
| Infiltration anaesthesia | 22 | 2,758.2 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 — unassessed | serious n=22 · ♀ 100% (drug 66%) | not reported in cached trials |
| Actinomycotic sepsis | 17 | 2,664.1 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 — unassessed | serious n=17 | not reported in cached trials |
| Human anti-human antibody test | 16 | 1,823.6 846.4–3,928.8ROR 1,825.3 · χ² 11,143 / p <1e-300 | 393.1 EB05 256.5 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=16 | not reported in cached trials |
| Body height below normal | 311 | 1,178.0 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 artifact | serious n=311 · ♀ 100% (drug 66%) | not reported in cached trials |
| Febrile infection-related epilepsy syndrome | 11 | 725.8 345.5–1,525.0ROR 726.3 · χ² 4,594 / p <1e-300 | 255.9 EB05 152.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Alpha tumour necrosis factor increased | 30 | 597.0 386.6–921.9ROR 598.1 · χ² 11,691 / p <1e-300 | 321.7 EB05 236.2 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 0% (drug 66%) | not reported in cached trials |
| Serum amyloid a protein increased | 46 | 534.0 378.3–753.8ROR 535.5 · χ² 16,790 / p <1e-300 | 324.2 EB05 252.9 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=46 | not reported in cached trials |
| Ankle arthroplasty | 95 | 459.9 363.7–581.4ROR 462.5 · χ² 31,489 / p <1e-300 | 315.3 EB05 265.6 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=95 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| Autoinflammatory disease | 54 | 451.3 330.8–615.8ROR 452.8 · χ² 17,512 / p <1e-300 | 297.2 EB05 236.4 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=46 | not reported in cached trials |
| Tumour necrosis factor receptor-associated periodic syndrome | 15 | 417.9 233.0–749.5ROR 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=14 | not reported in cached trials |
| Short stature | 59 | 371.7 278.1–496.8ROR 373.0 · χ² 16,540 / p <1e-300 | 262.5 EB05 211.0 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 100% (drug 66%) | not reported in cached trials |
| Intestinal sepsis | 50 | 313.4 230.0–427.1ROR 314.4 · χ² 12,208 / p <1e-300 | 229.0 EB05 180.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=50 · ♀ 0% (drug 66%) | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 421 | 281.3 253.4–312.4ROR 288.7 · χ² 95,834 / p <1e-300 | 227.6 EB05 209.9 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=417 · ♀ 95% (drug 66%) | not reported in cached trials |
| Joint destruction | 254 | 246.9 216.0–282.2ROR 250.7 · χ² 51,761 / p <1e-300 | 203.3 EB05 183.1 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=254 · ♀ 100% (drug 66%) · 93% clinician | not reported in cached trials |
| Skin graft infection | 10 | 241.1 122.6–474.3ROR 241.2 · χ² 1,809 / p <1e-300 | 146.5 EB05 85.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Propionibacterium infection | 17 | 236.8 141.1–397.6ROR 237.1 · χ² 3,162 / p <1e-300 | 163.2 EB05 107.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Juvenile idiopathic arthritis | 371 | 227.2 203.6–253.5ROR 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=370 | not reported in cached trials |
| Antibody test positive | 235 | 207.0 180.5–237.5ROR 210.0 · χ² 41,183 / p <1e-300 | 175.3 EB05 157.3 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=235 · ♀ 97% (drug 66%) | not reported in cached trials |
| Immune effector cell-associated haematotoxicity | 18 | 201.5 122.5–331.4ROR 201.7 · χ² 2,923 / p <1e-300 | 147.0 EB05 98.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Hair follicle tumour benign | 15 | 195.9 113.7–337.5ROR 196.1 · χ² 2,350 / p <1e-300 | 139.8 EB05 89.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Interleukin level increased | 70 | 192.0 149.4–246.8ROR 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 lymphoma | 48 | 188.1 138.9–254.6ROR 188.6 · χ² 7,604 / p <1e-300 | 153.8 EB05 120.6 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 100% (drug 66%) | not reported in cached trials |
| Bone density increased | 49 | 177.5 131.7–239.4ROR 178.1 · χ² 7,381 / p <1e-300 | 146.8 EB05 115.5 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=49 · ♀ 100% (drug 66%) | not reported in cached trials |
| Vexas syndrome | 11 | 176.8 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 — unassessed | serious n=11 | not reported in cached trials |
| Herpes zoster infection neurological | 19 | 170.1 105.4–274.7ROR 170.3 · χ² 2,666 / p <1e-300 | 130.6 EB05 88.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Cryopyrin associated periodic syndrome | 20 | 145.8 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% consumer | not reported in cached trials |
| Body tinea | 58 | 145.7 111.1–191.2ROR 146.2 · χ² 7,339 / p <1e-300 | 125.3 EB05 100.5 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 100% (drug 66%) | not reported in cached trials |
| Pneumonia lipoid | 13 | 139.3 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 — unassessed | serious n=13 | not reported in cached trials |
| Hyperferritinaemia | 40 | 135.9 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 — unassessed | serious n=40 · ♀ 45% (drug 66%) | not reported in cached trials |
| Soft tissue disorder | 106 | 133.2 109.1–162.6ROR 134.0 · χ² 12,450 / p <1e-300 | 118.0 EB05 100.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=106 · ♀ 100% (drug 66%) | NCT04330638: 2/36 (5.6%) on Anakinra |
| Polyarthritis | 490 | 130.9 119.4–143.5ROR 134.8 · χ² 57,079 / p <1e-300 | 118.1 EB05 109.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=490 · ♀ 96% (drug 66%) | not reported in cached trials |
| Apparent death | 322 | 123.0 109.8–137.7ROR 125.4 · χ² 35,369 / p <1e-300 | 111.3 EB05 101.5 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=322 · ♀ 0% (drug 66%) | not reported in cached trials |
| Testicular seminoma (pure) | 10 | 121.7 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 — unassessed | serious n=10 | not reported in cached trials |
| Haemophagocytic lymphohistiocytosis | 631 | 121.7 112.3–131.9ROR 126.5 · χ² 68,769 / p <1e-300 | 110.7 EB05 103.6 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 92.3 · 92% clinician | not reported in cached trials |
| Drug specific antibody | 119 | 121.5 100.7–146.6ROR 122.4 · χ² 12,855 / p <1e-300 | 108.9 EB05 93.5 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=119 · ♀ 100% (drug 66%) | not reported in cached trials |
| Growth failure | 30 | 120.5 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 — unassessed | serious n=30 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Clubbing | 34 | 114.9 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 — unassessed | serious n=34 · 91% clinician | not reported in cached trials |
| Diaphragm muscle weakness | 13 | 114.8 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 — unassessed | serious n=13 | not 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).
- NCT04330638 — Treatment of COVID-19 Patients With Anti-interleukin Drugs (N=342, PHASE3; 69 AE terms posted; arms: Usual Care; Anakinra; Siltuximab; Anakinra + Siltuximab)
- NCT03002974 — A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis (N=165, PHASE2; 109 AE terms posted; arms: Triamcinolone 40 mg; Anakinra 100 mg; Anakinra 200 mg)
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.
| 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 · χ² 30,658 / p <1e-300 | 7.6 EB05 7.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | not reported in cached trials |
| Drug ineffective (drug did not work) | 4,243 | 4.1 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 artifact | serious PRR 8.2 | not reported in cached trials |
| Condition aggravated | 1,689 | 7.1 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 artifact | serious PRR 8.1 | not reported in cached trials |
| Pain | 1,587 | 3.3 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 3.5 | NCT04330638: 1/74 (1.4%) on Anakinra (serious AE) |
| Rheumatoid arthritis | 1,549 | 17.6 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 17.0 | not reported in cached trials |
| Arthralgia (joint pain) | 1,198 | 3.7 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 swelling | 1,190 | 12.7 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 — unassessed | serious PRR 17.1 | not reported in cached trials |
| Drug intolerance | 1,167 | 15.6 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 artifact | serious PRR 20.7 | not reported in cached trials |
| Pyrexia (fever) | 1,164 | 4.3 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 3.6 | NCT03002974: 2/54 (3.7%) on Anakinra |
| Injection site pain (pain where injected) | 1,026 | 4.3 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% consumer | NCT04330638: 1/74 (1.4%) on Anakinra (serious AE) |
| Rash | 978 | 2.9 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 3.7 | NCT04330638: 2/32 (6.2%) on Anakinra |
| Nausea | 956 | 1.5 1.4–1.6ROR 1.6 · χ² 188 / p 4e-43 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT04330638: 2/32 (6.2%) on Anakinra |
| Product dose omission issue | 917 | 4.1 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 artifact | serious PRR 5.5 · 92% consumer | not reported in cached trials |
| Infection | 902 | 8.0 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 7.0 | NCT04330638: 1/74 (1.4%) on Anakinra (serious AE) |
| Vomiting | 877 | 2.4 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.
- 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 (also seen in trial arm)
- 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, fieldpatient.drug.openfda.generic_name.exact, 1,097 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 - ClinicalTrials.gov API v2 (query
ANAKINRA, results-bearing studies sorted by enrollment)
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.