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Anakinra

Anakinra is a biologic medication used to treat moderately to severely active rheumatoid arthritis, Neonatal-Onset Multisystem Inflammatory Disease (NOMID), and a rare genetic condition called Deficiency of Interleukin-1 Receptor Antagonist (DIRA).

Brand name Kineret
Drug class Interleukin-1 Receptor Antagonist
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 3, 2026
Anakinra at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Anakinra (Kineret) is a daily biologic injection that calms inflammation by blocking interleukin-1, a protein that drives it, at its receptor; on the market since about 2001, it is used less often for rheumatoid arthritis than other biologics but is a key treatment for NOMID and DIRA, two rare genetic inflammatory diseases. Most people tolerate it well, and what they notice most is redness, swelling or soreness where they inject. The real risk is serious infection, so it is not started during an active infection or combined with a TNF blocker like adalimumab. Expect blood tests for neutrophils (infection-fighting white blood cells), monthly at first, then every three months.

Clinical pearls

  • Live vaccines are off limits while on anakinra, so mention it before any shot and ideally catch up on vaccines beforehand.
  • Rotate injection sites every time, since long-term injections into one spot have been linked to amyloid (protein) deposits and lumps.
  • Severe kidney disease or dialysis can change the injection schedule, so make sure your prescriber knows about your kidney function.
  • A tuberculosis check comes before the first dose, because blocking interleukin-1 can let a hidden TB infection become active.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asInjection, Oral solution
Earliest FDA record2001
Companies listing it with the FDA5
FDA label last updatedApr 3, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Anakinra, written from its FDA label.

What Anakinra is used for

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Anakinra is a biologic medicine that targets a key driver of inflammation called interleukin-1 (IL-1). It is currently available as Kineret injection and is approved for three conditions:

  • Rheumatoid arthritis (RA): Kineret injection is used in adults (18 and older) with moderately to severely active RA who have not had enough benefit from at least one disease-modifying antirheumatic drug (DMARD). It reduces symptoms and slows structural joint damage.
  • Neonatal-Onset Multisystem Inflammatory Disease (NOMID): Kineret injection treats this rare, severe inflammatory condition that is part of the Cryopyrin-Associated Periodic Syndromes (CAPS) family. It is approved for use in pediatric patients.
  • Deficiency of Interleukin-1 Receptor Antagonist (DIRA): Kineret injection treats this rare inherited disease where the body lacks a natural protein that keeps IL-1 inflammation in check, leading to widespread skin and bone inflammation.

How Anakinra works

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Your immune system uses a signaling protein called interleukin-1 (IL-1) to trigger inflammation. In rheumatoid arthritis, NOMID, and DIRA, IL-1 activity goes into overdrive — breaking down cartilage, eroding bone, and causing widespread inflammation. Anakinra is a man-made version of a protein your body naturally produces to keep IL-1 in check. It works by attaching to the IL-1 receptor and blocking both forms of IL-1 (alpha and beta) from delivering their inflammatory signal. This helps calm the immune response and protect joints and other tissues from ongoing damage.

In DIRA specifically, patients are born without the ability to produce this natural blocking protein, so anakinra directly replaces what is missing and restores the balance.

Anakinra dosage

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Anakinra (Kineret) is given as an injection under the skin (subcutaneous injection) and is generally taken once daily. For rheumatoid arthritis, the dose is given at approximately the same time every day. For NOMID and DIRA, the dose is adjusted based on body weight and disease activity and may occasionally be split into twice-daily injections. Patients with severe kidney disease or end-stage renal disease may be advised to inject every other day instead of daily.

  • Always use a new syringe for each dose and discard any unused portion
  • Rotate injection sites each time to protect the skin
  • Follow your healthcare provider's specific instructions — do not adjust your dose on your own

Dosing details from the FDA-approved label

From the Anakinra prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Rheumatoid Arthritis (RA)
    • 100 mg/day administered daily by subcutaneous injection, at approximately the same time every day
    • Consider 100 mg every other day for severe renal insufficiency or end stage renal disease (creatinine clearance < 30 mL/min)
  • Cryopyrin-Associated Periodic Syndromes (CAPS) - NOMID patients
    • Starting dose 1-2 mg/kg daily
    • Adjust in 0.5 to 1 mg/kg increments
    • Once daily administration generally recommended, but the dose may be split into twice daily administrations
    • Maximum: 8 mg/kg daily
    • Consider the prescribed dose every other day for severe renal insufficiency or end stage renal disease (creatinine clearance < 30 mL/min)
  • Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
    • Starting dose 1-2 mg/kg daily
    • Adjust in 0.5 to 1 mg/kg increments
    • Maximum: 8 mg/kg daily
    • Consider the prescribed dose every other day for severe renal insufficiency or end stage renal disease (creatinine clearance < 30 mL/min)
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Rheumatoid Arthritis (RA) The recommended dose of KINERET for the treatment of patients with rheumatoid arthritis is 100 mg/day administered daily by subcutaneous injection. The dose should be administered at approximately the same time every day ( 2.1 ) Physicians should consider a dose of 100 mg of KINERET administered every other day for RA patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels) ( 2.4 ) Cryopyrin-Associated Periodic Syndromes (CAPS) The recommended starting dose of KINERET is 1-2 mg/kg daily for NOMID patients. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. ( 2.2 ) Physicians should consider administration of the prescribed KINERET dose every other day for NOMID patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels) ( 2.4 ) Deficiency of Interleukin-1 Receptor Antagonist (DIRA) The recommended starting dose of KINERET is 1-2 mg/kg daily for patients with DIRA. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. ( 2.3 ) Physicians should consider administration of the prescribed KINERET dose every other day for patients with DIRA who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels) ( 2.4 ) See full prescribing information for administration instructions ( 2.4 ) 2.1 Active Rheumatoid Arthritis The recommended dose of KINERET for the treatment of patients with rheumatoid arthritis is 100 mg/day administered daily by subcutaneous injection. Higher doses did not result in a higher response. The dose should be administered at approximately the same time every day. 2.2 Cryopyrin-Associated Periodic Syndromes (CAPS) The recommended starting dose of KINERET is 1-2 mg/kg for NOMID patients. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. Adjust doses in 0.5 to 1 mg/kg increments. Once daily administration is generally recommended, but the dose may be split into twice daily administrations. Each syringe is intended for a single use.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Anakinra side effects

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Common side effects

  • Injection site reactions (redness, bruising, swelling, or pain at the injection site)
  • Upper respiratory tract infections
  • Headache
  • Nausea
  • Diarrhea
  • Sinusitis
  • Flu-like symptoms
  • Fever (pyrexia)

When to get medical help

  • Signs of serious infection — fever, chills, persistent cough, or unusual wounds — call your doctor right away
  • Symptoms of a severe allergic reaction — swelling of the face or throat, difficulty breathing, or severe skin rash — get emergency help immediately
  • Low white blood cell count (neutropenia) — increased infections, mouth sores, or unusual fatigue; your doctor will monitor your blood counts regularly
  • Signs of unusual skin reactions, such as widespread rash with fever or swollen lymph nodes (DRESS syndrome)
  • Unusual lumps, swelling, or protein in urine, which may signal amyloid deposits at injection sites or systemic amyloidosis

The most common side effect of Kineret is a reaction at the injection site, reported by the majority of patients especially in the first month of treatment.

  • Injection site redness, bruising, swelling, or pain (most common — usually mild and temporary)
  • Upper respiratory tract infections
  • Headache
  • Nausea or diarrhea
  • Sinusitis
  • Flu-like symptoms
  • Fever
  • Low neutrophil counts (a type of white blood cell)

More serious reactions to watch for include signs of infection (fever, chills, unusual wounds), severe allergic reactions (throat swelling, difficulty breathing, widespread rash), and symptoms of neutropenia such as unusual fatigue or frequent infections. Contact your doctor or seek emergency care if any of these occur.

Anakinra warnings and precautions

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  • Serious infections: Kineret increases the risk of serious bacterial infections like pneumonia and cellulitis. Do not start it during an active infection. If you develop a serious infection while on Kineret for RA, it should be stopped. Your doctor should also screen for latent TB before you begin.
  • No combination with TNF blockers: Using Kineret together with TNF blocking agents (like etanercept) dramatically raises the risk of serious infection and is not recommended.
  • Low white blood cell counts (neutropenia): Kineret can reduce neutrophils, the white blood cells that fight bacteria. Blood counts must be checked monthly for the first 3 months, then quarterly for up to a year.
  • Allergic reactions: Severe allergic reactions including anaphylaxis (life-threatening allergic response), angioedema (swelling), and serious skin reactions like DRESS have been reported. DIRA patients are at particular risk in the first few weeks of treatment.
  • Amyloid deposits: Long-term high-dose use injected into the same skin area has caused protein deposits (amyloidosis) at injection sites and, in some cases, in the kidneys. Rotating injection sites is important to reduce this risk.
  • Live vaccines: Do not receive live vaccines while on Kineret. Inactivated vaccines appear safe, but check with your doctor first.

Anakinra interactions

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Anakinra has a small number of known clinically important interactions to be aware of:

  • TNF blocking agents (e.g., etanercept, adalimumab): Combining Kineret with these drugs significantly increases the risk of serious infections and is not recommended.
  • Live vaccines: Should not be given at the same time as Kineret, as there is no safety data and a theoretical risk of infection from the live virus.

Interactions listed in the FDA-approved label

From the Anakinra prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • TNF blocking agents (etanercept): A higher rate of serious infections has been observed in patients treated with concurrent KINERET and etanercept than with etanercept alone; two percent developed neutropenia (ANC < 1 x 10 9 /L). Use of KINERET in combination with TNF blocking agents is not recommended.
  • Methotrexate: No drug-drug interaction studies in humans have been conducted; rat toxicologic and toxicokinetic studies did not show altered clearance or toxicologic profile of either methotrexate or KINERET when given together.
Read the label’s full interactions text

7 DRUG INTERACTIONS No drug-drug interaction studies in human subjects have been conducted. 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. 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. Use of KINERET in combination with TNF blocking agents is not recommended ( 7 ) 7.1 TNF Blocking Agents A higher rate of serious infections has been observed in patients treated with concurrent KINERET and etanercept therapy than in patients treated with etanercept alone [see Warnings and Precautions ( 5.2 )] . Two percent of patients treated concurrently with KINERET and etanercept developed neutropenia (ANC < 1 x 10 9 /L). Use of KINERET in combination with TNF blocking agents is not recommended.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Check Anakinra against a supplement or herb →

Before taking Anakinra

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  • Active infection: Do not start Kineret if you currently have an infection — it must be treated first.
  • Allergy to E. coli-derived proteins or any ingredient in Kineret: Kineret is contraindicated if you have a known hypersensitivity.
  • Severe kidney disease or dialysis: The drug is cleared primarily by the kidneys; your doctor may reduce the frequency of dosing to avoid buildup in the body.
  • Older adults: Elderly patients have a generally higher risk of infections and should use this drug with extra caution.
  • Pregnancy: Data is very limited; there are risks linked to the underlying diseases themselves. Discuss the benefits and risks carefully with your doctor.
  • Pediatric patients: Kineret is approved for use in children with NOMID and DIRA; it is not approved for rheumatoid arthritis in patients under 18.
  • Asthma: Patients with asthma appeared to be at higher risk of serious infections in clinical trials — let your doctor know.
  • Immunosuppression or chronic infections: The safety of Kineret has not been evaluated in these situations; use with caution and close monitoring.

Anakinra overdose

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No overdose cases were reported in clinical trials of Kineret for rheumatoid arthritis or NOMID. In separate clinical research using much higher doses over short periods, no serious toxicities from the drug itself were identified. If you think you or someone else has taken too much, contact a poison control center or seek medical attention right away.

How your body processes Anakinra

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After a subcutaneous (under-the-skin) injection, Kineret is almost completely absorbed — about 95% of the dose reaches the bloodstream. In people with rheumatoid arthritis, blood levels peak roughly 3 to 7 hours after injection, and the drug clears the body with a half-life (the time for blood levels to drop by half) of about 4 to 6 hours. No unexpected buildup was seen with daily dosing over months of treatment.

The kidneys are the main route of elimination, so people with severe kidney disease or end-stage renal disease clear the drug much more slowly — up to 75% slower — meaning the dose schedule may need adjustment. Dialysis removes very little of the drug from the body.

How to store Anakinra

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KINERET should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE OR SHAKE. Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Anakinra: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Anakinra — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Kineret used for?

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Kineret is a biologic injection used for three conditions. In adults, it helps treat moderately to severely active rheumatoid arthritis when other disease-modifying drugs haven't worked well enough. It's also used for two rarer inflammatory diseases — NOMID (a severe childhood inflammatory syndrome) and DIRA (a genetic condition where the body can't control inflammation on its own). Your doctor prescribed it because your immune system is overproducing a protein called IL-1 that's driving inflammation, and Kineret blocks that signal.

How do I take Kineret, and do I need to refrigerate it?

▾
Kineret comes as a prefilled syringe that you inject just under the skin — usually once a day, at about the same time each day. Your healthcare provider will show you how to inject it properly before you do it at home. Each syringe is single-use only, so discard it after every dose — even if there's some left over. Very importantly, rotate where you inject each time (for example, alternate arms, thighs, or abdomen) to protect the skin and reduce the risk of protein deposits building up under the skin. Check the product's instructions for use for storage guidance.

What side effects should I expect, and which ones should I call my doctor about?

▾
The most common thing people notice is redness, swelling, or mild pain at the injection site — this is very common, especially in the first month, and is usually mild and gets better on its own. You might also get headaches, a runny nose, or flu-like symptoms. The things to call your doctor about right away are signs of infection — fever, chills, an unusual wound that isn't healing — or any signs of a serious allergic reaction like swelling of the face or throat or difficulty breathing. Those are not wait-and-see situations.

Is it safe to get vaccinations while I'm on Kineret?

▾
It depends on the type of vaccine. Live vaccines — like the nasal flu spray, MMR, or shingles vaccine (Zostavax, not Shingrix) — should not be given while you're taking Kineret. There's no safety data, and there's a concern the live virus could cause infection since Kineret affects your immune system. Inactivated vaccines like the tetanus shot appear to be fine. Before any vaccine, check with your doctor first so they can make sure it's the right type.

I have kidney disease — is Kineret safe for me?

▾
Kineret is mainly cleared by the kidneys, so if your kidney function is significantly reduced, the drug stays in your body longer. If you have severe kidney disease or are on dialysis, your doctor may prescribe Kineret every other day instead of daily to avoid it building up. Make sure your doctor knows your kidney status before you start, and at every check-in. Dialysis doesn't remove much of the drug from your body, so the adjusted schedule is the key safeguard.

Can I take Kineret with my other arthritis medicines?

▾
Kineret can be used alongside many other disease-modifying arthritis drugs (DMARDs). However, there is one important exception: it should NOT be combined with TNF blockers — medicines like etanercept or adalimumab. When those two types of biologics are used together, the risk of serious infections goes up significantly, without any added benefit. Always tell your doctor and pharmacist every medicine you're taking so they can check for this and other potential issues.

Is Anakinra available over the counter?

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No. Anakinra is a prescription medicine: every Anakinra product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Anakinra first available?

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The earliest FDA record we hold for Anakinra is from 2001: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Anakinra was first used.

Who makes Anakinra?

▾
5 companies list Anakinra products in the FDA's NDC Directory, including Swedish Orphan Biovitrum AB (publ), Boehringer Ingelheim RCV GmbH & Co KG, Hospira Zagreb d.o.o.. That count includes repackagers and distributors as well as manufacturers, so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Anakinra on HelloPharmacist

🌿Drug & Supplement CheckerAnakinra vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Anakinra NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Anakinra Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Anakinra forms and strengths (how it comes)

Anakinra is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Under the skin
Brands Kineret
How this form is used
What it may be used for
  • Kineret injection is used to reduce signs and symptoms and slow joint damage in adults with moderately to severely active rheumatoid arthritis who have not responded to at least one other disease-modifying drug
  • Kineret injection is used to treat Neonatal-Onset Multisystem Inflammatory Disease (NOMID) in pediatric and adult patients
  • Kineret injection is used to treat Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Important instructions
  • Kineret is injected subcutaneously (under the skin) once daily, at approximately the same time each day
  • Rotate injection sites with each dose to reduce the risk of skin reactions and amyloid deposits
  • Each Kineret prefilled syringe is for single use only — discard any unused portion after each dose
  • Do not use Kineret if the solution is discolored, cloudy, or contains unusual particles; inspect visually before each injection
Available strengths 1 strength
100 mg/0.67 mL
4 FDA-listed product records ⓘ

Oral solution

By mouth
Available strengths 2 strengths
220 mg/220 mg 1 kg/kg
2 FDA-listed product records ⓘ

Anakinra on the U.S. market: products, makers and brands

How Anakinra appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

5 companies list 6 Anakinra product records with the FDA, mostly as injection, oral solution; the earliest marketing or approval year on record is 2001. Brand names on the directory include Kineret; the rest are generics.

2
Dose forms ⓘ
5
Labelers (makers, repackagers, distributors)
1
Brand names
6
FDA-listed product records ⓘ
2001
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Swedish Orphan Biovitrum AB (publ)33%
Boehringer Ingelheim RCV GmbH & Co KG17%
Hospira Zagreb d.o.o.17%
Patheon Italia S.p.A17%
Pfizer Health AB17%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Anakinra is used (Medicaid data)

A general measure of how commonly Anakinra is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Anakinra is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,205
Medicaid prescriptions filled (Q1–Q4 2025)
$23.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Anakinra prescribed? Of the 1,599 medications we measure, Anakinra ranks #1,115 by Medicaid prescriptions — more than 30% of them.

Where Anakinra ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,115 of 1,599
#1,110 Ezetimibe / Simvastati... 3,300 Rx #1,111 Chloroprocaine 3,292 Rx #1,112 Luspatercept-aamt Inje... 3,270 Rx #1,113 Asciminib 3,208 Rx #1,114 Povidone-Iodine 3,207 Rx #1,115 Anakinra 3,205 Rx #1,116 Efgartigimod alfa-fcab... 3,198 Rx #1,117 Nilotinib 3,130 Rx #1,118 Metformin / Pioglitazo... 3,108 Rx #1,119 Flurbiprofen 3,098 Rx #1,120 Clindamycin / Tretinoi... 3,090 Rx

Utilization by Anakinra product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

0.67 ML anakinra 149 MG/ML Prefilled Syringe

3,205 Medicaid prescriptions (Q1–Q4 2025) 100% of Anakinra prescriptions shown $23.2M gross reimbursement (before rebates) ≈ $7,235 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 727711

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Anakinra, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Anakinra NDCs with Medicaid activity.

Compare Anakinra products

A representative set of FDA-listed product records for Anakinra — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Injection
100 mg/0.67 mL — Hospira Zagreb d.o.o. DRUG FOR FURTHER PROCESSING View NDC →
100 mg/0.67 mL — Patheon Italia S.p.A DRUG FOR FURTHER PROCESSING View NDC →
100 mg/0.67 mL Subcutaneous Swedish Orphan Biovitrum AB (publ) × 2 listings BLA View NDC →
💊Oral solution
220 mg/220 mg — Boehringer Ingelheim RCV GmbH & Co KG BULK INGREDIENT View NDC →
1 kg/kg — Pfizer Health AB BULK INGREDIENT View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Anakinra NDCs →

Anakinra recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Anakinra recalls since July 2021.

✅No Anakinra recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Anakinra RxCUI 72435 1 dose form · 1 strength
  1. Dose form (SCDF) Prefilled Syringe RxCUI 727708 No current FDA listing
    Clinical drug / strength (SCD) 0.67 ML anakinra 149 MG/ML RxCUI 727711

Look up RxCUI 72435 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Anakinra brand names

Anakinra is sold under one brand name in the FDA directory — Kineret. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Kineret

Who makes Anakinra: manufacturers and labelers

5 companies list Anakinra products with the FDA. By number of product records, the largest are Swedish Orphan Biovitrum AB (publ), Boehringer Ingelheim RCV GmbH & Co KG, Hospira Zagreb d.o.o.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Swedish Orphan Biovitrum AB (publ) 2 Boehringer Ingelheim RCV GmbH & Co KG 1 Hospira Zagreb d.o.o. 1 Patheon Italia S.p.A 1 Pfizer Health AB 1

Anakinra drug class (RxNorm)

Anakinra belongs to the Interleukin-1 Receptor Antagonist class.

Pharmacologic class Interleukin-1 Receptor Antagonist
Drug family (ATC) Interleukin inhibitors
How it works Interleukin 1 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Anakinra page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Apr 3, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Anakinra.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Anakinra after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
6
Distinct labelers/manufacturers represented
5
Linked representative label ⓘ
Swedish Orphan Biovitrum AB (publ)
Linked label effective
Apr 3, 2026
Composite sections available
23
Linked SPL Set ID
d9d74915-6606-4570-9c52-c4001d3177de
Linked SPL Document ID
d1acb9d5-9241-4aeb-b3e7-f05dbc8c15a2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Swedish Orphan Biovitrum AB (publ) is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →