RITUXIMAB-ARRX: 347 Adverse Event Reports & Safety Profile

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347

Total FAERS Reports

11 (3.2%)

Deaths Reported

Hospitalizations

347

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Prescription

Status

FDA Application: 761140 ·

First Report: 20080101 · Latest Report: 20250908

What Are the Most Common RITUXIMAB-ARRX Side Effects?

#1 Most Reported

Product storage error

165 reports (47.6%)

#2 Most Reported

Circumstance or information capable of leading to medication error

116 reports (33.4%)

#3 Most Reported

Off label use

56 reports (16.1%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Product storage error	165	47.6%	0	0
Circumstance or information capable of leading to medication error	116	33.4%	0	0
Off label use	56	16.1%	9	14
Intercepted product administration error	51	14.7%	0	0
Accidental exposure to product	17	4.9%	0	0
Intercepted product preparation error	16	4.6%	0	0
Fatigue	14	4.0%	6	8
Infusion related reaction	14	4.0%	6	7
Drug ineffective	12	3.5%	6	8
Dyspnoea	12	3.5%	4	6
Malaise	12	3.5%	4	5
Pruritus	12	3.5%	4	5
Drug intolerance	10	2.9%	6	8
Rash	10	2.9%	5	6
Rheumatoid arthritis	9	2.6%	6	8
Dizziness	8	2.3%	4	6
Hypertension	8	2.3%	6	6
Pain	8	2.3%	4	6
Systemic lupus erythematosus	8	2.3%	6	6
Treatment failure	8	2.3%	4	7

Gender: 60.6% female, 39.4% male. Average age: 57.0 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2008	3	1	3
2019	1	0	0
2021	3	1	0
2022	14	0	0
2023	50	0	2
2024	51	0	5
2025	15	2	0

Indication	Reports
Product used for unknown indication	247
Rheumatoid arthritis	15
Off label use	9
Non-hodgkin's lymphoma	8
Immune thrombocytopenia	7
Lymphoma	7
Multiple sclerosis	6
Diffuse large b-cell lymphoma	5

Official prescribing information from the FDA-approved drug label.