Drug class · FAERS comparison

CD20-directed Cytolytic Antibody side effects compared: 7 drugs, 318,918 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)
Rituximab (Rituxan)	210,132	89%	37,069	boxed	Duodenal ulcer perforation; Rheumatic fever; Sleep disorder due to general medical condition, insomnia type	Synovitis; Hand deformity
Ocrelizumab (Ocrevus)	61,582	50%	1,519	–	Ear pruritus; Genital herpes; Multiple sclerosis pseudo relapse	Covid-19; Cystitis noninfective
Ofatumumab (Kesimpta)	33,036	44%	762	–	Chills; Brain fog; Cytopenia	Influenza like illness; Temperature intolerance
Rituximab-Pvvr (Ruxience)	5,068	90%	471	boxed	Throat irritation; Infusion related reaction; Heart rate increased	Covid-19; Cataract
Rituximab-Abbs (Truxima)	4,946	73%	516	boxed	Infusion related reaction; Systemic lupus erythematosus; Type 2 diabetes mellitus	Helicobacter infection; Synovitis
Ublituximab (Briumvi)	3,775	22%	62	–	Infusion related reaction; Urinary tract infection; Multiple sclerosis relapse	Balance disorder; Herpes zoster
Rituximab-Arrx (Riabni)	379	16%	14	boxed	Circumstance or information capable of leading to medication error	–

Class-wide signals (flagged in at least 4 of 7 members)

No term is flagged in at least half the members.

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Magnetic resonance imaging spinal abnormal	Ocrelizumab	61	351.9	Not in label — unassessed
Rheumatic fever	Rituximab	3,199	280.1	Labeled (related wording)
Vaccine interaction	Rituximab	227	280.0	Not in label — unassessed
Swollen joint count	Rituximab	176	256.0	Not in label — unassessed
Lupus vulgaris	Rituximab	827	231.6	Labeled (related wording)
Duodenal ulcer perforation	Rituximab	4,935	208.1	Labeled — boxed warning
Deep vein thrombosis postoperative	Rituximab	1,318	207.9	Not in label — unassessed
Diffuse large b-cell lymphoma recurrent	Rituximab	1,437	205.1	Labeled (related wording)
Circumstance or information capable of leading to medication error	Rituximab-Arrx	116	192.0	Labeled (related wording)
Facet joint syndrome	Rituximab	2,003	176.0	Not in label — unassessed
Chronic lymphocytic leukaemia recurrent	Rituximab	429	164.0	Likely indication confounding
Mantle cell lymphoma recurrent	Rituximab	263	160.2	Likely indication confounding
Granuloma skin	Rituximab	507	158.9	Labeled (related wording)
B-cell lymphoma recurrent	Rituximab	325	150.8	Likely indication confounding
Grip strength	Rituximab	139	150.5	Not in label — unassessed
Lymphoma transformation	Rituximab	212	143.5	Likely indication confounding
Humoral immune defect	Rituximab	207	126.1	Not in label — unassessed
Adjustment disorder with depressed mood	Rituximab	1,074	114.3	Not in label — unassessed
Dislocation of vertebra	Rituximab	1,091	96.2	Not in label — unassessed
Diffuse large b-cell lymphoma refractory	Rituximab	450	93.7	Likely indication confounding
Subcutaneous drug absorption impaired	Rituximab	257	89.1	Not in label — unassessed
Hypocholesterolaemia	Rituximab	141	84.3	Not in label — unassessed
Muscle injury	Rituximab	3,701	82.0	Not in label — unassessed
Follicular lymphoma	Rituximab	383	81.3	Labeled adverse reaction
Retinitis	Rituximab	721	75.8	Not in label — unassessed

Common questions

Which cd20-directed cytolytic antibody has the most FDA adverse event reports?

Rituximab has the most FAERS co-reports in this class (210,132), followed by Ocrelizumab (61,582). 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 cd20-directed cytolytic antibody drugs?

No reaction term is flagged in at least half of the members; the signals in this class are largely product-specific or population-specific.

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.