Rituximab-Pvvr side effects: what 5,068 FDA adverse event reports show

Rituximab-Pvvr · Ruxience · 334 reaction terms · 18,658 drug–reaction co-reports · data 2026-09-14

Drug class

CD20-directed Cytolytic Antibody

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Ruxience

openFDA label

Who reports

5,068 reports · 90% serious · 471 with death outcome · 66% female

openFDA FAERS counts, all years, deduplication not applied

Used for

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

FDA label, Indications and Usage

What it is

Rituximab-pvvr is a genetically engineered chimeric murine/human monoclonal IgG 1 kappa antibody directed against the CD20 antigen. Rituximab-pvvr has an approximate molecular weight of 145 kD. Rituximab-pvvr is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.

FDA label, Description section

Boxed warning

FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred.

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 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 2Labeled (related wording) 7Likely indication confounding 1Reporting / coding artifact 6Lab value / disease marker 7Not in label — unassessed 16

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 294 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
Blood pressure fluctuation	252	43.8 38.8–49.4ROR 46.0 · χ² 10,390 / p <1e-300	43.2 EB05 38.9 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious PRR 34.2 · 99% clinician	no trial data cached
Intentional product use issue	639	30.3 28.2–32.6ROR 34.5 · χ² 18,003 / p <1e-300	30.0 EB05 28.1 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 27.6 · 96% clinician	no trial data cached
Throat irritation	313	29.2 26.2–32.5ROR 31.0 · χ² 8,444 / p <1e-300	28.9 EB05 26.3 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 40.4 · 96% clinician	no trial data cached
Blood pressure systolic increased	134	28.5 24.1–33.7ROR 29.2 · χ² 3,505 / p <1e-300	28.2 EB05 24.4 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious PRR 19.2 · 96% clinician	no trial data cached
Poor venous access	65	26.2 20.6–33.4ROR 26.5 · χ² 1,542 / p <1e-300	25.9 EB05 21.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=65 · 94% clinician	no trial data cached
Pharyngeal swelling	41	17.8 13.1–24.1ROR 17.9 · χ² 631 / p 2e-139	17.6 EB05 13.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=41 · 90% clinician	no trial data cached
Throat tightness	101	15.5 12.8–18.8ROR 15.8 · χ² 1,355 / p 8e-297	15.4 EB05 13.0 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.6	no trial data cached
Incorrect product administration duration	71	14.5 11.5–18.3ROR 14.7 · χ² 878 / p 3e-193	14.4 EB05 11.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious n=69 · 99% clinician	no trial data cached
Vasculitis	39	13.9 10.2–19.0ROR 14.0 · χ² 452 / p 1e-100	13.6 EB05 10.2 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.0	no trial data cached
Pulmonary fibrosis	61	13.2 10.3–17.0ROR 13.4 · χ² 677 / p 2e-149	13.0 EB05 10.4 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Drug effective for unapproved indication	89	12.6 10.3–15.5ROR 12.8 · χ² 941 / p 7e-207	12.5 EB05 10.4 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious n=84 · 98% clinician	no trial data cached
Heart rate irregular	66	12.0 9.5–15.3ROR 12.2 · χ² 656 / p 5e-145	11.8 EB05 9.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.8 · 98% clinician	no trial data cached
Heart rate decreased	99	11.6 9.6–14.1ROR 11.8 · χ² 951 / p 4e-209	11.5 EB05 9.6 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 9.0 · 91% clinician	no trial data cached
Infusion related reaction (reaction during infusion)	185	11.6 10.1–13.4ROR 12.0 · χ² 1,785 / p <1e-300	11.5 EB05 10.2 · IC025 +3.3 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 7.2 · 91% clinician	no trial data cached
Oxygen saturation decreased	156	11.6 9.9–13.5ROR 11.9 · χ² 1,499 / p <1e-300	11.5 EB05 10.0 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 7.9 · 93% clinician	no trial data cached
C-reactive protein increased	93	10.6 8.7–13.0ROR 10.8 · χ² 799 / p 5e-176	10.4 EB05 8.7 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 6.9 · 96% clinician	no trial data cached
Off label use (used outside approved label)	2,180	10.4 10.1–10.8ROR 17.5 · χ² 19,302 / p <1e-300	10.4 EB05 10.0 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.8 · 94% clinician	no trial data cached
Body temperature decreased	24	10.0 6.7–14.9ROR 10.1 · χ² 186 / p 1e-42	9.1 EB05 6.2 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 7.1 · 100% clinician	no trial data cached
Therapeutic response shortened	76	9.9 7.9–12.4ROR 10.0 · χ² 599 / p 2e-132	9.6 EB05 7.9 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 18.0	no trial data cached
Red blood cell sedimentation rate increased	26	9.7 6.6–14.3ROR 9.8 · χ² 194 / p 2e-44	8.9 EB05 6.2 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 7.0	no trial data cached
Cataract	135	9.4 8.0–11.1ROR 9.7 · χ² 1,010 / p 5e-222	9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Dry throat	23	9.4 6.2–14.1ROR 9.4 · χ² 164 / p 8e-38	8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=20 · ♀ 86% (drug 66%) · 96% clinician	no trial data cached
Joint range of motion decreased	30	9.3 6.5–13.3ROR 9.4 · χ² 214 / p 1e-48	8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · ♀ 41% (drug 66%) · 100% clinician	no trial data cached
Paraesthesia oral	32	9.2 6.5–13.0ROR 9.3 · χ² 226 / p 2e-51	8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.1 · ♀ 88% (drug 66%) · 97% clinician	no trial data cached
Tooth extraction	27	9.0 6.2–13.1ROR 9.0 · χ² 183 / p 4e-42	8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Ear discomfort	21	8.5 5.5–13.0ROR 8.5 · χ² 131 / p 1e-30	7.5 EB05 5.1 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=21 · ♀ 100% (drug 66%) · 100% clinician	no trial data cached
Condition aggravated	613	8.4 7.8–9.1ROR 9.4 · χ² 4,048 / p <1e-300	8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · 92% clinician	no trial data cached
Covid-19	358	8.4 7.6–9.3ROR 8.9 · χ² 2,337 / p <1e-300	8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Tooth infection	26	8.2 5.6–12.0ROR 8.2 · χ² 156 / p 4e-36	7.4 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.6	no trial data cached
Inappropriate schedule of product administration	345	8.1 7.3–9.0ROR 8.6 · χ² 2,150 / p <1e-300	8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.7 · 94% clinician	no trial data cached
Hip arthroplasty	29	7.9 5.5–11.4ROR 8.0 · χ² 168 / p 1e-38	7.2 EB05 5.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Lymphoma	28	7.5 5.2–10.8ROR 7.5 · χ² 151 / p 6e-35	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.8 · ♀ 41% (drug 66%)	no trial data cached
Infusion site pain	23	7.5 5.0–11.2ROR 7.5 · χ² 122 / p 1e-28	6.6 EB05 4.6 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious n=21	no trial data cached
Feeling cold	50	7.4 5.6–9.8ROR 7.5 · χ² 272 / p 3e-61	7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.8 · 92% clinician	no trial data cached
Localised infection	42	7.2 5.3–9.7ROR 7.2 · χ² 218 / p 2e-49	6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.9	no trial data cached
Knee arthroplasty	35	7.0 5.0–9.7ROR 7.0 · χ² 172 / p 1e-39	6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.6 · 100% clinician	no trial data cached
Synovitis	30	6.9 4.8–9.8ROR 6.9 · χ² 145 / p 1e-33	6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.6 · 100% clinician	no trial data cached
Heart rate increased	164	6.9 5.9–8.0ROR 7.1 · χ² 818 / p 3e-180	6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4 · 93% clinician	no trial data cached
Foot deformity	18	6.7 4.2–10.7ROR 6.7 · χ² 82 / p 7e-20	5.8 EB05 3.9 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.0	no trial data cached
Covid-19 pneumonia	19	6.6 4.2–10.4ROR 6.6 · χ² 85 / p 1e-20	5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	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
Off label use (used outside approved label)	2,180	10.4 10.1–10.8ROR 17.5 · χ² 19,302 / p <1e-300	10.4 EB05 10.0 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 11.8 · 94% clinician	no trial data cached
Intentional product use issue	639	30.3 28.2–32.6ROR 34.5 · χ² 18,003 / p <1e-300	30.0 EB05 28.1 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 27.6 · 96% clinician	no trial data cached
Condition aggravated	613	8.4 7.8–9.1ROR 9.4 · χ² 4,048 / p <1e-300	8.4 EB05 7.8 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 7.8 · 92% clinician	no trial data cached
Fatigue (tiredness)	400	2.1 1.9–2.3ROR 2.2 · χ² 248 / p 3e-56	2.1 EB05 2.0 · IC025 +0.9	Labeled adverse reaction exact term	serious PRR 2.5	no trial data cached
Death	375	1.8 1.6–2.0ROR 1.9 · χ² 139 / p 3e-32	1.8 EB05 1.7 · IC025 +0.7	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 1.1	no trial data cached
Dyspnoea (shortness of breath)	368	2.7 2.4–3.0ROR 2.8 · χ² 401 / p 2e-89	2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.3 · 91% clinician	no trial data cached
Covid-19	358	8.4 7.6–9.3ROR 8.9 · χ² 2,337 / p <1e-300	8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.1	no trial data cached
Inappropriate schedule of product administration	345	8.1 7.3–9.0ROR 8.6 · χ² 2,150 / p <1e-300	8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 12.7 · 94% clinician	no trial data cached
Headache	335	2.2 2.0–2.5ROR 2.3 · χ² 229 / p 6e-52	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8 · 91% clinician	no trial data cached
Pruritus (itching)	335	3.7 3.3–4.1ROR 3.9 · χ² 659 / p 1e-145	3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.2 · 94% clinician	no trial data cached
Throat irritation	313	29.2 26.2–32.5ROR 31.0 · χ² 8,444 / p <1e-300	28.9 EB05 26.3 · IC025 +4.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 40.4 · 96% clinician	no trial data cached
Malaise (feeling unwell)	304	2.9 2.6–3.2ROR 3.0 · χ² 374 / p 1e-83	2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Pain	297	2.0 1.8–2.2ROR 2.1 · χ² 151 / p 4e-35	2.0 EB05 1.8 · IC025 +0.8	Labeled — boxed warning exact term	serious PRR 1.9	no trial data cached
Cough	283	4.2 3.7–4.7ROR 4.4 · χ² 692 / p 7e-153	4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5 · 90% clinician	no trial data cached
Pneumonia (lung infection)	254	3.3 2.9–3.7ROR 3.4 · χ² 400 / p 3e-89	3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 2.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Poor venous access — n=65, PRR 26.2
Pharyngeal swelling — n=41, PRR 17.8
Pulmonary fibrosis — n=61, PRR 13.2
Heart rate irregular — n=66, PRR 12.0
Cataract — n=135, PRR 9.4
Joint range of motion decreased — n=30, PRR 9.3
Tooth extraction — n=27, PRR 9.0
Ear discomfort — n=21, PRR 8.5
Covid-19 — n=358, PRR 8.4
Tooth infection — n=26, PRR 8.2

✓ 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-Pvvr?

In FDA FAERS, the most frequently co-reported reaction terms for Rituximab-Pvvr are fatigue, dyspnoea, covid-19, headache, pruritus, throat irritation. 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-Pvvr 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 Infusion-Related Reactions Administration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred.

Do FAERS signals prove that Rituximab-Pvvr 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 f941fc61-f7a3-4e4a-ab7c-87c1667fa05b, effective 20260826; matched on openfda.generic_name.exact:"RITUXIMAB-PVVR")
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, 334 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.