What the label lists and what reports show
Anakinra side effects
Anakinra's FDA label: “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 …” FAERS holds 16,492 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (1,587 reports).
- No generic listed
Check it at the source: the anakinra FDA label on DailyMed (effective April 3, 2026, Swedish Orphan Biovitrum AB (publ)); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of KINERET?KINERET may cause serious side effects, including: serious infections. KINERET may lower your ability to fight infections. During your treatment with KINERET, call your healthcare provider right away if you: get an infection. have any sign of an infection including a fever or chills. have any open sores on your body. You may get an infection if you receive live vaccines while you use KINERET. You should not receive live vaccines while you use KINERET. serious allergic reactions. […]
Source: FDA drug label, Swedish Orphan Biovitrum AB (publ), effective April 3, 2026 (SPL set d9d74915-6606-4570-9c52-c4001d3177de), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost 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 […]
Table 1: Percent of RA Patients Reporting Adverse Events (Studies 1 and 4)
| Preferred term | Placebo (n = 733) | KINERET 100 mg/day (n = 1565) |
|---|---|---|
| Injection Site Reaction | 29% | 71% |
| Worsening of RA | 29% | 19% |
| Upper Respiratory Tract Infections | 17% | 14% |
| Headache | 9% | 12% |
| Nausea | 7% | 8% |
| Diarrhea | 5% | 7% |
| Sinusitis | 7% | 7% |
| Arthralgia | 6% | 6% |
| Flu Like Symptoms | 6% | 6% |
| Abdominal Pain | 5% | 5% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedBecause 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. …
Source: FDA drug label, Swedish Orphan Biovitrum AB (publ), effective April 3, 2026 (SPL set d9d74915-6606-4570-9c52-c4001d3177de), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,492 reports list anakinra among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,515 are coded as a death and 5,193 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Anakinra: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions