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Anakinra Side Effects

Not all side effects for anakinra may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to anakinra: subcutaneous solution

In addition to its needed effects, some unwanted effects may be caused by anakinra. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking anakinra:

More common
  • Diarrhea
  • fever or chills
  • headache
  • itching, pain, redness, swelling, tenderness or warmth on the skin
  • joint pain
  • muscle aches and pains
  • nausea or vomiting
  • runny nose or sneezing
  • sore throat
Less common or rare
  • Difficulty with swallowing
  • hives, itching, or rash
  • swelling of the face or lips
  • unusual bruising or bleeding
  • unusual tiredness or weakness
Incidence not known
  • Dizziness
  • fast heartbeat
  • hives or welts
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

Some of the side effects that can occur with anakinra may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • 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


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


Five patients with rheumatoid arthritis developed inflammatory lesions at the injection site coincident with anakinra therapy. The onset of the reaction was within the first month of therapy and appeared well-defined erythema and edema. The treatment had been discontinued in two patients, and in one patient it was associated with systemic involvement.[Ref]

Local side effects have been reported the most frequently. These have included injection site reactions (55.83% to 72.6%) including erythema, ecchymosis, inflammation, and pain. The majority were characterized as mild severity and lasted for 14 to 28 days. At least 5 cases of inflammatory lesions at the injection site have also been reported.[Ref]


Hematologic side effects have included decreases in absolute neutrophil count (8%), total white blood cell count, and platelets, and small increases in the eosinophil differential percentage. Neutropenia has been reported in 0.3% of study patients receiving anakinra monotherapy and in 3% of patients receiving combination therapy with etanercept.[Ref]


Immunologic side effects have included development of immunogenicity. Twenty-eight percent of study patients tested positively for anti-anakinra antibodies at 6 months and less than 1% of patients tested seropositive for anakinra neutralizing antibodies.[Ref]


Gastrointestinal side effects have included nausea (8%), diarrhea (7%), and abdominal pain (5%).[Ref]


Respiratory side effects have included upper respiratory tract infections (13%) sinusitis (6%), and bronchitis (3.4%).[Ref]

Nervous system

Nervous system side effects have included headache (12%).[Ref]


Musculoskeletal side effects have included arthralgia (6%).[Ref]


Genitourinary side effects including urinary tract infections have been reported in 4.6% of patients.[Ref]


Dermatologic side effects including at least one case of psoriasis have been reported.[Ref]

A 75-year-old female with a history of rheumatoid arthritis experienced psoriasis coincident with anakinra therapy. She was administered anakinra therapy 100 mg daily subcutaneously. Nine months later, the patient presented with typical psoriatic, scaly, erythematous plaques on the elbows. Skin biopsy from the patient's left elbow revealed psoriasiform hyperplasia, parakeratosis and lymphocytic infiltrate in the upper dermis, consistent with psoriasis. Therapy with anakinra was discontinued, and the psoriatic lesions improved significantly with the addition of topical steroids and vitamin D. The implication of anakinra in the development of psoriasis seems likely given the temporal relationship between the initiation of anakinra therapy and the onset of the skin condition; and the absence of other known triggering factors for the onset of psoriasis.[Ref]


Patients who received both anakinra and etanercept had a higher incidence of serious infections (7%).

Asthmatic patients had a higher risk of serious infections (5% vs. less than 1% for placebo).[Ref]

Other side effects including Influenza-like symptoms have been reported in 5.8% of patients. Serious infections that were primarily bacterial have been reported in 1.8% of patients vs. 0.6% for placebo. These have included cellulitis, pneumonia, and bone and joint infections.[Ref]


Hepatic postmarketing side effects have included elevations of transaminases and non-infectious hepatitis.


1. "Product Information. Kineret (anakinra)." Amgen, Thousand Oaks, CA.

2. Vila AT, Puig L, Fernandez-Figueras MT, Laiz AM, Vidal D, Alomar A "Adverse cutaneous reactions to anakinra in patients with rheumatoid arthritis: clinicopathological study of five patients." Br J Dermatol 153 (2005): 417-23

3. Gartlehner G, Hansen RA, Jonas BL, Thieda P, Lohr KN "The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis." J Rheumatol 33 (2006): 2398-408

4. Fleischmann RM, Schechtman J, Bennett R, et al. "Anakinra, a recombinant human interleukin-1 receptor antagonist (r-metHuIL-1ra), in patients with rheumatoid arthritis: A large, international, multicenter, placebo-controlled trial." Arthritis Rheum 48 (2003): 927-34

5. Tesser J, Fleischmann R, Dore R, et al. "Concomitant medication use in a large, international, multicenter, placebo controlled trial of anakinra, a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis." J Rheumatol 31 (2004): 649-54

6. Callen JP "Complications and adverse reactions in the use of newer biologic agents." Semin Cutan Med Surg 26 (2007): 6-14

7. Weisman MH "What are the risks of biologic therapy in rheumatoid arthritis? An update on safety." J Rheumatol 29 Suppl 65 (2002): 33-8

8. Gonzalez-Lopez MA, Martinez-Taboada VM, Gonzalez-Vela MC, Fernandez-Llaca H, Val-Bernal JF "New-onset psoriasis following treatment with the interleukin-1 receptor antagonist anakinra." Br J Dermatol 158 (2008): 1146-8

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