Pharmacologic class (EPC) · 17 drug pages

Tumor necrosis factor blocker: adverse event reports filed with FDA

1,064,042 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.

1,064,042
reports across the class: 5.2% of all reports; 42,562
reports, 12 months to June 2026: 55,315 in the 12 months before; 56.2%
marked serious by the reporter: 57.4% across all reports; 17
drugs with a page: brand and generic names counted separately

Tumor necrosis factor blocker is a pharmacologic class (an FDA Established Pharmacologic Class) with 17 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 1,064,042 adverse event reports received by FDA, 5.2% of the database, from January 2004 to June 2026.

42,562 reports arrived in the 12 months to June 2026, down 23% from 55,315 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 56.2% of the class's reports are marked serious, 5.2% record death among the outcomes and 18.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (16.3%), off label use (10.5%) and rheumatoid arthritis (10.1%). 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
EnbrelEtanercept	brand	561,339	4,674	33.3%	Drug ineffective
RemicadeInfliximab	brand	155,227	3,304	87.4%	Drug ineffective
CimziaCertolizumab pegol	brand	87,221	4,932	54.9%	Drug ineffective
SimponiGolimumab	brand	70,407	4,803	75%	Drug ineffective
Infliximab	generic	52,582	7,092	97.3%	Off label use
Adalimumab	generic	39,338	7,362	95.7%	Drug ineffective
Certolizumab pegol	generic	27,395	2,232	97.2%	Drug ineffective
InflectraInfliximab-dyyb	brand	25,300	863	83.4%	Off label use
Etanercept	generic	18,397	1,381	96.3%	Drug ineffective
HyrimozAdalimumab-adaz	brand	8,482	1,970	83.9%	Off label use
Golimumab	generic	7,163	929	96.8%	Drug ineffective
Simponi AriaGolimumab	brand	3,633	170	31.4%	Drug ineffective
RenflexisInfliximab	brand	2,067	419	86.6%	Off label use
Infliximab-dyyb	generic	2,027	1,394	86.3%	Intentional dose omission
AmjevitaAdalimumab-atto	brand	1,416	334	22.5%	Device difficult to use
HadlimaAdalimumab-bwwd	brand	1,087	428	61.9%	Injection site pain
AvsolaInfliximab-axxq	brand	961	275	51.7%	Off label use

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 expected16.3%173,226
Off label useused for a purpose or in a way not on the label10.5%112,106
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease10.1%107,735
Painpain, site not specified9.4%99,784
Arthralgiajoint pain8.8%93,909
Fatiguetiredness7.8%82,753
Condition aggravatedthe condition being treated got worse6.7%71,536
Rashskin rash6%63,437
Joint swellinga swollen joint5.9%63,006
Injection site painpain where the injection was given5.7%60,643
Headachehead pain5.4%57,529
Drug intolerancethe medicine was not tolerated5.1%54,202
Alopeciahair loss5%53,575
Nauseafeeling sick4.8%51,080
Abdominal discomfortstomach discomfort4.7%49,760
Contraindicated product administered4.6%48,428
Hypersensitivityan allergic-type reaction4.4%47,220
Arthropathy4.4%46,990
Infusion related reactiona reaction during or soon after an infusion4.4%46,652
Systemic lupus erythematosuslupus, an autoimmune disease4.4%46,492
Malaisegeneral feeling of being unwell4.3%46,041
Swellingswelling4.3%45,854
Nasopharyngitisa cold4.2%44,563
Pain in extremitypain in an arm or leg4.1%43,526
Treatment failurethe treatment did not work4%42,369

Solid bar: share of all class reports. Hollow bar: the median share across the 17 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.2%55,766

Life-threatening4.2%45,182

Hospitalisation (initial or prolonged)18.2%194,121

Disability4.8%51,360

Congenital anomaly1.6%17,401

Other serious45.2%481,232

Not serious43.8%466,416

Patient age

Under 20.2%1,629

2 to 110.8%8,710

12 to 171.8%18,814

18 to 4416.4%174,087

45 to 6427.8%296,279

65 to 749.6%102,243

75 and over4.2%44,822

Age not given39.2%417,458

Who reported

Physician32.4%344,819

Pharmacist3.3%34,936

Other health professional31%329,403

Lawyer0%273

Consumer or non-health professional32.3%343,471

Not given1%11,140

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 Tumor necrosis factor blocker reports

Which drugs are in the Tumor necrosis factor blocker class on this site?

Enbrel, Remicade, Cimzia, Simponi, Infliximab and Adalimumab and 11 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

1,064,042 reports through June 2026, 42,562 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 (16.3%), off label use (10.5%), rheumatoid arthritis (10.1%), pain (9.4%) and arthralgia (8.8%).

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.