Pharmacologic class (EPC) · 2 drug pages

Interleukin-1 receptor antagonist: adverse event reports filed with FDA

14,178 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

14,178
reports across the class: 0.1% of all reports; 871
reports, 12 months to June 2026: 974 in the 12 months before; 66.3%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Interleukin-1 receptor antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 14,178 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

871 reports arrived in the 12 months to June 2026, down 11% from 974 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 66.3% of the class's reports are marked serious, 8.6% record death among the outcomes and 30% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (32.6%), drug ineffective (26.2%) and condition aggravated (10.9%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
KineretAnakinra	brand	8,539	405	46.5%	Off label use
Anakinra	generic	5,639	466	96.3%	Drug ineffective

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Off label useused for a purpose or in a way not on the label32.6%4,628
Drug ineffectivethe medicine did not work as expected26.2%3,721
Condition aggravatedthe condition being treated got worse10.9%1,542
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease10.3%1,454
Painpain, site not specified10.1%1,439
Drug intolerancethe medicine was not tolerated7.2%1,015
Injection site painpain where the injection was given7.1%1,003
Joint swellinga swollen joint6.9%979
Arthralgiajoint pain6.7%943
Pyrexiafever6.5%928
Product dose omission issuea dose was missed6.3%897
Nauseafeeling sick6%855
Contraindicated product administered5.6%799
Rashskin rash5.6%793
Diarrhoealoose or frequent stools5.5%773
Arthropathy5%714
Infectionan infection, type not specified5%713
Injection site erythemaredness where the injection was given5%713
Drug hypersensitivityan allergic-type reaction to a medicine4.6%657
Vomitingbeing sick4.6%646
Mobility decreasedreduced ability to move about4.5%644
Treatment failurethe treatment did not work4.5%641
Red blood cell sedimentation rate increased4.5%635
Therapeutic product effect decreased4.4%625
Fatiguetiredness4.1%587

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death8.6%1,215

Life-threatening6.8%965

Hospitalisation (initial or prolonged)30%4,248

Disability3%430

Congenital anomaly0.4%63

Other serious48.4%6,866

Not serious33.7%4,783

Patient age

Under 21.9%270

2 to 117.9%1,117

12 to 174.5%634

18 to 4414.3%2,029

45 to 6420.3%2,883

65 to 747.1%1,004

75 and over3.1%446

Age not given40.9%5,795

Who reported

Physician20.4%2,896

Pharmacist1.9%272

Other health professional29.3%4,156

Lawyer0%3

Consumer or non-health professional45.5%6,450

Not given2.8%401

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Interleukin-1 receptor antagonist reports

Which drugs are in the Interleukin-1 receptor antagonist class on this site?

Kineret and Anakinra. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

14,178 reports through June 2026, 871 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

off label use (32.6%), drug ineffective (26.2%), condition aggravated (10.9%), rheumatoid arthritis (10.3%) and pain (10.1%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.