RITUXIMAB-ABBS: 4,347 Adverse Event Reports & Safety Profile

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4,347

Total FAERS Reports

432 (9.9%)

Deaths Reported

1,087

Hospitalizations

4,347

As Primary/Secondary Suspect

313

Life-Threatening

167

Disabilities

Prescription

Status

FDA Application: 761088 ·

First Report: 20100206 · Latest Report: 20250913

What Are the Most Common RITUXIMAB-ABBS Side Effects?

#1 Most Reported

Off label use

2,167 reports (49.9%)

#2 Most Reported

Intentional product use issue

273 reports (6.3%)

#3 Most Reported

Dyspnoea

208 reports (4.8%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Off label use	2,167	49.9%	125	256
Intentional product use issue	273	6.3%	77	124
Dyspnoea	208	4.8%	65	104
Pain	205	4.7%	60	102
Rheumatoid arthritis	202	4.7%	64	109
Intentional dose omission	196	4.5%	14	76
Fatigue	195	4.5%	60	94
Drug ineffective	186	4.3%	59	73
Hypertension	183	4.2%	64	99
Infusion related reaction	183	4.2%	55	76
Rash	183	4.2%	51	102
Pyrexia	180	4.1%	50	119
Nausea	170	3.9%	36	74
Death	167	3.8%	167	19
Headache	167	3.8%	65	78
Arthralgia	163	3.8%	62	89
Underdose	155	3.6%	62	101
Hypersensitivity	148	3.4%	71	94
Pruritus	147	3.4%	28	51
Condition aggravated	141	3.2%	61	86

Gender: 74.2% female, 25.8% male. Average age: 53.5 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2010	1	0	1
2015	8	3	4
2017	53	5	25
2018	245	37	125
2019	326	32	192
2020	448	37	153
2021	386	38	87
2022	363	37	101
2023	220	12	57
2024	176	12	71
2025	71	7	30

Indication	Reports
Rheumatoid arthritis	820
Product used for unknown indication	373
Diffuse large b-cell lymphoma	288
Immune thrombocytopenia	235
Vasculitis	151
B-cell lymphoma	133
Systemic lupus erythematosus	129
Mantle cell lymphoma	123
Multiple sclerosis	120
Non-hodgkin's lymphoma	111

Official prescribing information from the FDA-approved drug label.