Anakinra: uses, dosing, side effects & brands
Anakinra is a medicine sold in the U.S. under one brand, for rheumatoid arthritis and cryopyrin-associated periodic syndromes. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Rheumatoid Arthritis and Cryopyrin-Associated Periodic Syndromes
- Available as
- Injectable
- Sold as
- Kineret
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How anakinra is dosed
From the FDA label for Kineret (application BLA103950). Other anakinra products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Anakinra side effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Rheumatoid Arthritis (RA) Most common adverse reactions (incidence ≥ 5%) are injection site reaction, worsening of rheumatoid arthritis, upper respiratory tract infection, headache, nausea, diarrhea, sinusitis, arthralgia, flu like-symptoms, and abdominal pain ( 6.1 ) NOMID The most common AEs during the first 6 months of treatment (incidence > 10%) are injection site reaction, headache, vomiting, arthralgia, pyrexia, and nasopharyngitis ( 6.2 ) DIRA The most common AEs are upper respiratory tract infections, rash, pyrexia, influenza like illness, and gastroenteritis ( 6.3 ) To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-547-0644 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience in RA The most serious adverse reactions were: Serious Infections – [see Warnings and Precautions ( 5.1 )] Neutropenia, particularly when used in combination with TNF blocking agents The most common adverse reaction with KINERET is injection-site reactions. These reactions were the most common reason for withdrawing from studies. The data described herein reflect…
Who shouldn’t take anakinra
KINERET is contraindicated in patients with known hypersensitivity to E coli -derived proteins, KINERET, or any components of the product [see Hypersensitivity Reactions ( 5.3 )] . Known hypersensitivity to E coli -derived proteins, Kineret, or to any component of the product. ( 4 )
Anakinra 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.
Every anakinra product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Kineret.
Can you crush or split anakinra?
The anakinra labels that address it permit crushing or splitting in the terms they state — quoted per product, because the instruction belongs to the form.
What each anakinra label says about crushing, splitting and chewingAnakinra and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for anakinra: levels in milk, effects in breastfed infants, and the drugs it would consider insteadAnakinra is the pharmaceutical name for recombinant human interleukin-1 receptor antagonist (IL-1Ra). IL-1Ra is a normal component of human milk where it may play a role as an anti-inflammatory agent. Many infants have been breastfed during maternal anakinra therapy, occasionally in conjunction with colchicine, with no obvious adverse effects or infections. Several international guidelines state that the drug is a low risk to the nursing infant and acceptable to use during breastfeeding.
National Institute of Child Health and Human Development, record revised April 15, 2026. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about anakinra
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 7,538 reports naming anakinra, and the FDA flagged 95% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- rheumatoid arthritis1,262 reports
- drug intolerance1,092 reports
- joint swelling1,018 reports
- contraindicated product administered815 reports
- arthralgia753 reports
- drug hypersensitivity747 reports
- synovitis737 reports
- arthropathy670 reports
Read these as a signal, not a rate. A report does not mean anakinra caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is anakinra?
Kineret (Anakinra) is a medication used to treat Rheumatoid Arthritis, Cryopyrin-Associated Periodic Syndromes.
Can you take anakinra with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run anakinra against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does anakinra come in?
Across the brands we track, anakinra is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic anakinra?
We do not currently list a generic-labelled anakinra product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Anakinra: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/anakinra
- MLA
- “Anakinra: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/anakinra.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for anakinra on DailyMed (NIH) ↗.