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Anakinra Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 3, 2022.


Commonly reported side effects of anakinra include: infection, antibody development, and inflammation at injection site. Other side effects include: neutropenia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to anakinra: subcutaneous solution

Side effects requiring immediate medical attention

Along with its needed effects, anakinra may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking anakinra:

More common

Less common

  • Difficulty with swallowing
  • hives, itching, or rash
  • swelling of the face or lips
  • unusual bruising or bleeding
  • unusual tiredness or weakness

Incidence not known

  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • dizziness
  • fast heartbeat
  • hives or welts
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

Side effects not requiring immediate medical attention

Some side effects of anakinra may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • difficulty with moving
  • headache
  • muscle aches or stiffness

For Healthcare Professionals

Applies to anakinra: subcutaneous solution


The most serious side effects have included infections and neutropenia, while the most common side effects have included injection site reactions.[Ref]


Very common (10% or more): Injection site reaction (71%) (including erythema, ecchymosis, inflammation, and pain)[Ref]


Common (1% to 10%): Neutropenia, decreased total white blood cell count, decreased platelets

Frequency not reported: small increases in the eosinophil differential percentage[Ref]


Very common (10% or more): Vomiting (14%)

Common (1% to 10%): Nausea, diarrhea, abdominal pain[Ref]


Very common (10% or more): Upper respiratory tract infection (19%), nasopharyngitis (11%)

Common (1% to 10%): Sinusitis, bronchitis[Ref]

Nervous system

Very common (10% or more): Headache (12%)[Ref]


Common (1% to 10%): Arthralgia[Ref]


Common (1% to 10%): Urinary tract infection[Ref]


Very common (10% or more): Worsening of RA (19%), pyrexia (11%)[Ref]


Uncommon (0.1% to 1%): Hepatic enzyme increased

Frequency not reported: Non-infectious hepatitis, elevations of transaminases[Ref]


Uncommon (0.1% to 1%): Allergic reactions (including anaphylactic reactions), angioedema, urticaria, pruritus

Frequency not reported: Rash[Ref]


Common (1% to 10%): Serious infections (primarily bacterial) (e.g., cellulitis, pneumonia, bone and joint infections), influenza-like symptoms

Frequency not reported: Development of immunogenicity[Ref]


Frequency not reported: Increased rate of lymphoma[Ref]

Frequently asked questions


1. "Product Information. Kineret (anakinra)." Amgen (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online." (2006):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.