Prescription medicine
Anakinra Brand names: Kineret
Anakinra (Kineret) is a prescription medicine with an FDA approval on record since 2001. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the anakinra FDA label on DailyMed (effective April 3, 2026, Swedish Orphan Biovitrum AB (publ)); the BLA 103950 record on Drugs@FDA; every anakinra label on DailyMed.
Highlights of the record
FDA label of April 3, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageKINERET 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 or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Mu
Forms and strengths
- 100 mg/.67ml
Injection (solution).
On the market
- Earliest approval on file
- November 14, 2001 Kineret, Biovitrum Ab; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 16,492 through July 30, 2026
What is anakinra used for?
From the label: indications and usageKINERET 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 or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs) ( 1.1 ) Cryopyrin-Associated Periodic Syndromes (CAPS) Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) ( 1.2 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) ( 1.3 ) 1.1 Active Rheumatoid Arthritis KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). […]
FDA pharmacologic class: Interleukin-1 Receptor Antagonist.
Source: FDA drug label (Kineret), Swedish Orphan Biovitrum AB (publ), effective April 3, 2026 (SPL set d9d74915-6606-4570-9c52-c4001d3177de), via openFDA; the full label on DailyMed
Is there a generic for anakinra (Kineret)?
No generic anakinra is approved (Drugs@FDA, October 8, 2026).
- 2001 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the anakinra label say about other medicines?
The anakinra label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name anakinra. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Etanercept | drug interactions | A higher rate of serious infections has been observed in RA patients treated with concurrent KINERET and etanercept therapy than in patients treated with etanercept alone. |
| Methotrexate | drug interactions | Toxicologic and toxicokinetic studies in rats did not demonstrate any alterations in the clearance or toxicologic profile of either methotrexate or KINERET when the two agents were administered together. |
Other labels that name anakinra
Source: FDA drug label (Kineret), Swedish Orphan Biovitrum AB (publ), effective April 3, 2026 (SPL set d9d74915-6606-4570-9c52-c4001d3177de), via openFDA; the full label on DailyMed
What do FAERS reports show for anakinra?
The FDA Adverse Event Reporting System holds 16,492 reports that list anakinra among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,515 are coded as a death and 5,193 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Anakinra side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other