Anakinra Side Effects

Please note - some side effects for Anakinra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Anakinra - for the Consumer

Anakinra

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Anakinra:

Diarrhea; flu-like symptoms; headache; nausea; reaction at the injection site (eg, redness, swelling, bruising, itching, pain, stinging); sinus inflammation; stomach pain; upper respiratory tract infection.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough; infection (fever, chills, sore throat); unexplained bone or joint pain.

Side Effects by Body System

General

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

Local

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.

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.

Hematologic

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.

Immunologic

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.

Gastrointestinal

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

Respiratory

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

Nervous system

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

Musculoskeletal

Musculoskeletal side effects have included arthralgia (6%).

Genitourinary

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

Other

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).

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.

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