Drug class · FAERS comparison

Tumor Necrosis Factor Blocker side effects compared: 9 drugs, 1,025,019 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14

How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

Drug	FAERS reports	Serious	Death outcome	Boxed warning	Top labeled signals	Unlabeled (unassessed)
Etanercept (Enbrel)	595,118	36%	17,154	boxed	Injection site warmth; Injection site haematoma; Rheumatoid nodule	Synovitis; Hand deformity
Infliximab (Renflexis)	217,056	89%	13,761	boxed	Lupus-like syndrome; Rheumatic fever; Hepatosplenic t-cell lymphoma	Synovitis; Pemphigus
Certolizumab Pegol (Cimzia)	116,499	65%	6,589	boxed	Pericarditis; Rheumatic fever; Peripheral venous disease	Pemphigus; Glossodynia
Adalimumab-Adaz (Adalimumab)	52,421	93%	8,010	boxed	Duodenal ulcer perforation; Muscle injury; Peripheral venous disease	Pemphigus; Hand deformity
Infliximab-Dyyb (Inflectra)	29,058	83%	703	boxed	Anal fistula; Sinusitis bacterial; Treatment delayed	Anal fissure; Poor venous access
Golimumab (Simponi Aria)	12,299	76%	2,587	boxed	Peripheral venous disease; Granuloma skin; Hepatic enzyme	Pemphigus; Glossodynia
Adalimumab-Atto (Amjevita)	1,469	24%	15	boxed	Circumstance or information capable of leading to medication error; Injection site pain; Injury associated with device	Drug dose omission by device
Infliximab-Axxq (Avsola)	1,002	52%	26	boxed	Circumstance or information capable of leading to medication error; Infusion related reaction; Lower respiratory tract infection	Haematochezia; Ill-defined disorder
Adalimumab-Aqvh (Yusimry)	97	25%	2	boxed	–	–

Class-wide signals (flagged in at least 5 of 9 members)

Reaction	Members flagged	Median PRR	Reports (sum)	In label
Pemphigus	6/9	212.8	38,255	0/6 members' labels
Hand deformity	6/9	146.1	34,187	0/6 members' labels
Helicobacter infection	6/9	123.2	22,029	0/6 members' labels
Folliculitis	6/9	100.2	20,129	0/6 members' labels
Rheumatic fever	5/9	398.6	14,340	2/5 members' labels
Deep vein thrombosis postoperative	5/9	321.1	6,046	0/5 members' labels
Lupus vulgaris	5/9	317.5	3,738	0/5 members' labels
Duodenal ulcer perforation	5/9	273.0	21,305	1/5 members' labels
Facet joint syndrome	5/9	214.8	8,507	0/5 members' labels
Adjustment disorder with depressed mood	5/9	157.5	4,812	0/5 members' labels
Muscle injury	5/9	149.7	17,229	1/5 members' labels
Dislocation of vertebra	5/9	120.8	4,867	0/5 members' labels
Synovitis	5/9	96.4	35,025	0/5 members' labels

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Injection site recall reaction	Etanercept	486	911.8	Labeled (related wording)
Chronic recurrent multifocal osteomyelitis	Adalimumab-Adaz	57	423.1	Not in label — unassessed
Paradoxical psoriasis	Adalimumab-Adaz	172	277.3	Likely indication confounding
Malignant mediastinal neoplasm	Golimumab	56	265.4	Labeled (related wording)
Covid-19 immunisation	Certolizumab Pegol	449	205.4	Not in label — unassessed
Ear infection bacterial	Infliximab-Dyyb	59	200.7	Labeled (related wording)
Faecal calprotectin increased	Infliximab-Dyyb	619	179.1	Not in label — unassessed
Axial spondyloarthritis	Certolizumab Pegol	419	178.7	Likely indication confounding
Anal fissure	Infliximab-Dyyb	1,046	176.2	Not in label — unassessed
Sinusitis bacterial	Infliximab-Dyyb	199	167.1	Labeled (related wording)
Short stature	Adalimumab-Adaz	70	146.5	Not in label — unassessed
Cutaneous leishmaniasis	Adalimumab-Adaz	62	130.4	Not in label — unassessed
Bronchitis bacterial	Infliximab-Dyyb	96	103.3	Labeled (related wording)
White coat hypertension	Infliximab-Dyyb	66	100.3	Not in label — unassessed
Ankle arthroplasty	Golimumab	102	97.8	Not in label — unassessed
Hepatosplenic t-cell lymphoma	Infliximab	184	94.3	Labeled — boxed warning
Treatment delayed	Infliximab-Dyyb	179	89.8	Labeled (related wording)
Aphthous ulcer	Infliximab-Dyyb	753	78.5	Not in label — unassessed
Erythema nodosum	Infliximab-Dyyb	332	75.6	Not in label — unassessed
Injection site macule	Etanercept	470	74.5	Labeled (related wording)
Fistula discharge	Infliximab-Dyyb	111	69.1	Likely indication confounding
Exposure to sars-cov-2	Infliximab-Dyyb	146	67.0	Not in label — unassessed
Fistula	Infliximab-Dyyb	911	63.5	Likely indication confounding
Suspected off label use	Infliximab-Dyyb	139	62.8	Labeled (related wording)
Poor venous access	Infliximab-Dyyb	805	61.0	Not in label — unassessed

Common questions

Which tumor necrosis factor blocker has the most FDA adverse event reports?

Etanercept has the most FAERS co-reports in this class (595,118), followed by Infliximab (217,056). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across tumor necrosis factor blocker drugs?

Reaction terms flagged in at least half of the 9 members include pemphigus, hand deformity, helicobacter infection, folliculitis, rheumatic fever. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.