Anakinra Side Effects
Some side effects of anakinra may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to anakinra: subcutaneous solution
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
- fever or chills
- 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
- Difficulty with swallowing
- hives, itching, or rash
- swelling of the face or lips
- unusual bruising or bleeding
- unusual tiredness or weakness
- 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 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
- 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
- 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.
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 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 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 side effects have included nausea (8%), diarrhea (7%), and abdominal pain (5%).
Respiratory side effects have included upper respiratory tract infections (13%) sinusitis (6%), and bronchitis (3.4%).
Nervous system side effects have included headache (12%).
Musculoskeletal side effects have included arthralgia (6%).
Genitourinary side effects including urinary tract infections have been reported in 4.6% of patients.
Dermatologic side effects including at least one case of psoriasis have been reported.
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.
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.
Hepatic postmarketing side effects have included elevations of transaminases and non-infectious hepatitis.
More about anakinra
- Other brands: Kineret
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