Drug · FAERS side-effect profile with label screen

Rituximab and Hyaluronidase side effects: what 177,557 FDA adverse event reports show

Rituximab And Hyaluronidase · 46 reaction terms · 673 drug–reaction co-reports · data 2026-09-14

Drug class

CD20-directed Cytolytic Antibody

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Rituximab (Rituxan)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

177,557 reports · 95% serious · 34,150 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

RITUXAN is a CD20-directed cytolytic antibody indicated for the treatment of: Adult patients with Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previously untreated fo.

FDA label, Indications and Usage

What it is

Rituximab is a genetically engineered chimeric murine/human monoclonal IgG 1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituxima.

FDA label, Description section

Boxed warning

FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 39 strongest signals

Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 5Not in label — unassessed 26

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 7 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Helicobacter infection	17	78.2 49.0–124.7ROR 81.2 · χ² 1,218 / p 5e-267	72.0 EB05 47.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Laryngitis	18	77.7 49.4–122.3ROR 80.9 · χ² 1,286 / p 6e-282	71.9 EB05 48.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Folliculitis	17	77.1 48.4–123.0ROR 80.1 · χ² 1,201 / p 2e-263	71.1 EB05 47.0 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Hypercholesterolaemia	15	73.5 44.7–120.9ROR 76.0 · χ² 1,000 / p 9e-220	67.4 EB05 43.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Foot deformity	16	67.6 41.7–109.4ROR 70.0 · χ² 983 / p 5e-216	62.7 EB05 40.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Autoimmune disorder	13	63.6 37.2–108.8ROR 65.5 · χ² 740 / p 4e-163	58.4 EB05 36.3 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Wound infection	14	60.4 36.0–101.1ROR 62.3 · χ² 758 / p 3e-167	55.9 EB05 35.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Bursitis	15	58.3 35.4–95.8ROR 60.2 · χ² 787 / p 2e-173	54.4 EB05 35.0 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pemphigus	14	52.8 31.5–88.4ROR 54.4 · χ² 660 / p 9e-146	49.4 EB05 31.3 · IC025 +3.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	–	no trial data cached
Joint range of motion decreased	15	52.6 32.0–86.5ROR 54.4 · χ² 708 / p 3e-156	49.4 EB05 31.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hand deformity	14	50.1 29.9–84.0ROR 51.7 · χ² 626 / p 2e-138	47.1 EB05 29.8 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Weight fluctuation	11	49.5 27.6–88.7ROR 50.7 · χ² 475 / p 2e-105	45.8 EB05 27.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pericarditis	17	47.8 30.0–76.2ROR 49.6 · χ² 733 / p 1e-161	45.5 EB05 30.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hip arthroplasty	13	40.1 23.5–68.5ROR 41.3 · χ² 457 / p 1e-101	38.0 EB05 23.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lower limb fracture	16	39.2 24.3–63.5ROR 40.7 · χ² 559 / p 8e-124	37.6 EB05 24.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Sciatica	13	38.4 22.5–65.6ROR 39.5 · χ² 437 / p 3e-97	36.5 EB05 22.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Obesity	13	38.2 22.3–65.2ROR 39.3 · χ² 434 / p 1e-96	36.3 EB05 22.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Sleep disorder due to a general medical condition	13	37.7 22.0–64.3ROR 38.7 · χ² 428 / p 2e-95	35.8 EB05 22.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hepatic cirrhosis	15	37.6 22.9–61.8ROR 38.9 · χ² 498 / p 1e-110	36.0 EB05 23.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pulmonary fibrosis	15	36.8 22.3–60.5ROR 38.0 · χ² 487 / p 4e-108	35.2 EB05 22.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Synovitis	13	33.7 19.7–57.6ROR 34.7 · χ² 381 / p 4e-85	32.3 EB05 20.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ear infection	18	31.8 20.2–49.9ROR 33.0 · χ² 506 / p 2e-112	30.8 EB05 20.6 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Incorrect route of product administration	11	30.7 17.1–55.0ROR 31.4 · χ² 287 / p 1e-64	29.2 EB05 17.3 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Frequent bowel movements	17	29.6 18.6–47.2ROR 30.7 · χ² 442 / p 2e-98	28.7 EB05 19.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Glossodynia (burning tongue/mouth pain)	14	29.3 17.5–49.1ROR 30.2 · χ² 355 / p 1e-79	28.3 EB05 17.9 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Irritable bowel syndrome	13	28.5 16.7–48.7ROR 29.3 · χ² 318 / p 2e-71	27.4 EB05 17.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Knee arthroplasty	12	27.0 15.4–47.1ROR 27.7 · χ² 275 / p 6e-62	25.9 EB05 15.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Laboratory test abnormal	16	25.4 15.7–41.1ROR 26.3 · χ² 352 / p 1e-78	24.7 EB05 16.1 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Liver injury	13	25.2 14.7–43.0ROR 25.9 · χ² 278 / p 9e-63	24.3 EB05 15.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Fibromyalgia	13	25.1 14.7–42.8ROR 25.8 · χ² 277 / p 2e-62	24.2 EB05 14.9 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Wound	14	23.6 14.1–39.5ROR 24.3 · χ² 281 / p 3e-63	22.8 EB05 14.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
No adverse event	87	23.0 19.0–27.7ROR 28.3 · χ² 1,821 / p <1e-300	22.9 EB05 19.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Type 2 diabetes mellitus	16	22.2 13.7–35.9ROR 23.0 · χ² 303 / p 3e-68	21.6 EB05 13.9 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Systemic lupus erythematosus	16	21.2 13.1–34.3ROR 21.9 · χ² 288 / p 6e-65	20.6 EB05 13.2 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Impaired healing	14	20.0 11.9–33.4ROR 20.6 · χ² 234 / p 4e-53	19.3 EB05 11.8 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Psoriatic arthropathy	17	19.8 12.4–31.6ROR 20.5 · χ² 285 / p 3e-64	19.3 EB05 12.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Colitis ulcerative	13	13.6 8.0–23.3ROR 14.0 · χ² 140 / p 1e-32	12.4 EB05 6.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product storage error	15	8.1 4.9–13.3ROR 8.4 · χ² 87 / p 6e-21	6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site erythema (redness where injected)	16	6.1 3.7–9.8ROR 6.3 · χ² 63 / p 1e-15	5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
No adverse event	87	23.0 19.0–27.7ROR 28.3 · χ² 1,821 / p <1e-300	22.9 EB05 19.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Ear infection	18	31.8 20.2–49.9ROR 33.0 · χ² 506 / p 2e-112	30.8 EB05 20.6 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Laryngitis	18	77.7 49.4–122.3ROR 80.9 · χ² 1,286 / p 6e-282	71.9 EB05 48.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Psoriatic arthropathy	17	19.8 12.4–31.6ROR 20.5 · χ² 285 / p 3e-64	19.3 EB05 12.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Frequent bowel movements	17	29.6 18.6–47.2ROR 30.7 · χ² 442 / p 2e-98	28.7 EB05 19.0 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Pericarditis	17	47.8 30.0–76.2ROR 49.6 · χ² 733 / p 1e-161	45.5 EB05 30.1 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Folliculitis	17	77.1 48.4–123.0ROR 80.1 · χ² 1,201 / p 2e-263	71.1 EB05 47.0 · IC025 +3.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Helicobacter infection	17	78.2 49.0–124.7ROR 81.2 · χ² 1,218 / p 5e-267	72.0 EB05 47.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Injection site erythema (redness where injected)	16	6.1 3.7–9.8ROR 6.3 · χ² 63 / p 1e-15	5.2 EB05 3.4 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Systemic lupus erythematosus	16	21.2 13.1–34.3ROR 21.9 · χ² 288 / p 6e-65	20.6 EB05 13.2 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Type 2 diabetes mellitus	16	22.2 13.7–35.9ROR 23.0 · χ² 303 / p 3e-68	21.6 EB05 13.9 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Laboratory test abnormal	16	25.4 15.7–41.1ROR 26.3 · χ² 352 / p 1e-78	24.7 EB05 16.1 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Lower limb fracture	16	39.2 24.3–63.5ROR 40.7 · χ² 559 / p 8e-124	37.6 EB05 24.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Foot deformity	16	67.6 41.7–109.4ROR 70.0 · χ² 983 / p 5e-216	62.7 EB05 40.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Product storage error	15	8.1 4.9–13.3ROR 8.4 · χ² 87 / p 6e-21	6.8 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Rituximab ↔ Serious infection.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Rituximab and Hyaluronidase?

In FDA FAERS, the most frequently co-reported reaction terms for Rituximab and Hyaluronidase are ear infection, laryngitis, psoriatic arthropathy, frequent bowel movements, pericarditis, folliculitis. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Rituximab and Hyaluronidase have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY See full prescribing information for complete boxed warning.

Do FAERS signals prove that Rituximab and Hyaluronidase causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID b172773b-3905-4a1c-ad95-bab4b6126563, effective 20250106; matched on openfda.generic_name.exact:"RITUXIMAB")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 46 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.