Pharmacologic class (EPC) · 5 drug pages

Interleukin-6 receptor antagonist: adverse event reports filed with FDA

134,236 reports list a drug in this class as a suspect or interacting product, 2006–2026.

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.

134,236
reports across the class: 0.7% of all reports; 11,109
reports, 12 months to June 2026: 13,321 in the 12 months before; 70.4%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Interleukin-6 receptor antagonist is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 134,236 adverse event reports received by FDA, 0.7% of the database, from March 2006 to June 2026.

11,109 reports arrived in the 12 months to June 2026, down 17% from 13,321 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 70.4% of the class's reports are marked serious, 11.4% record death among the outcomes and 24.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (31.4%), rheumatoid arthritis (21.5%) and pain (20.7%). 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
ActemraTocilizumab	brand	80,095	3,726	73.6%	Drug ineffective
Tocilizumab	generic	25,705	1,767	95%	Off label use
KevzaraSarilumab	brand	23,264	4,486	36.8%	Pain
Actemra ACTPenTocilizumab	brand	3,153	958	23.6%	No adverse event
Sarilumab	generic	2,019	172	87.7%	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

Drug ineffectivethe medicine did not work as expected31.4%42,157
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease21.5%28,804
Painpain, site not specified20.7%27,763
Off label useused for a purpose or in a way not on the label18%24,228
Arthralgiajoint pain17.2%23,142
Joint swellinga swollen joint16.4%21,995
Fatiguetiredness15.1%20,206
Rashskin rash13.9%18,639
Drug intolerancethe medicine was not tolerated12.8%17,195
Contraindicated product administered12.4%16,642
Alopeciahair loss11.3%15,221
Arthropathy11.2%15,040
Abdominal discomfortstomach discomfort11.1%14,915
Synovitis10.8%14,528
Swellingswelling10.8%14,457
Condition aggravatedthe condition being treated got worse10.6%14,246
Hypersensitivityan allergic-type reaction10.6%14,226
Systemic lupus erythematosuslupus, an autoimmune disease10.5%14,097
Infusion related reactiona reaction during or soon after an infusion10.2%13,657
Treatment failurethe treatment did not work10.1%13,557
Pemphigus10.1%13,516
Hepatic enzyme increasedraised liver enzymes9.6%12,834
Headachehead pain9.5%12,758
Glossodynia9.4%12,593
Hand deformity9%12,085

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.4%15,325

Life-threatening9.3%12,424

Hospitalisation (initial or prolonged)24.6%33,062

Disability11%14,738

Congenital anomaly3.5%4,679

Other serious55.1%73,975

Not serious29.6%39,754

Patient age

Under 20.1%151

2 to 111%1,397

12 to 170.9%1,148

18 to 4413.5%18,056

45 to 6423.3%31,271

65 to 7410.7%14,305

75 and over6.7%9,059

Age not given43.8%58,849

Who reported

Physician28.2%37,816

Pharmacist2.9%3,884

Other health professional36.9%49,547

Lawyer0%44

Consumer or non-health professional31.3%41,957

Not given0.7%988

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-6 receptor antagonist reports

Which drugs are in the Interleukin-6 receptor antagonist class on this site?

Actemra, Tocilizumab, Kevzara, Actemra ACTPen and Sarilumab. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

134,236 reports through June 2026, 11,109 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?

drug ineffective (31.4%), rheumatoid arthritis (21.5%), pain (20.7%), off label use (18%) and arthralgia (17.2%).

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.