Drug · FAERS side-effect profile with label screen
Polatuzumab Vedotin side effects: what 9,696 FDA adverse event reports show
Drug class
Cd79b-directed antibody and microtubule inhibitor conjugate
FDA label, Indications wording
Brand names
Polivy
openFDA label
Who reports
9,696 reports · 95% serious · 2,075 with death outcome · 41% female
openFDA FAERS counts, all years, deduplication not applied
Used for
POLIVY is a CD79b-directed antibody and microtubule inhibitor conjugate indicated: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater.
FDA label, Indications and Usage
What it is
Polatuzumab vedotin-piiq is a CD79b-directed antibody and microtubule inhibitor conjugate. It consists of three components: 1) the humanized immunoglobulin G1 (IgG1) monoclonal antibody specif.
FDA label, Description section
Boxed warning
None in the current 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 adverse reaction 2Labeled (related wording) 2Likely indication confounding 9Reporting / coding artifact 1Lab value / disease marker 6Not in label — unassessed 20
What the badges mean
- 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. 952 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diffuse large b-cell lymphoma recurrent | 364 | 441.9 395.4–493.8ROR 459.1 · χ² 132,281 / p <1e-300 | 359.3 EB05 329.3 · IC025 +7.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=363 | no trial data cached |
| Follicular lymphoma recurrent | 11 | 390.8 205.6–743.1ROR 391.3 · χ² 3,292 / p <1e-300 | 210.3 EB05 125.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Ureteric compression | 10 | 328.0 168.6–638.0ROR 328.3 · χ² 2,549 / p <1e-300 | 184.8 EB05 107.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Diffuse large b-cell lymphoma refractory | 110 | 290.2 238.0–353.8ROR 293.5 · χ² 27,653 / p <1e-300 | 244.7 EB05 208.7 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=110 · 93% clinician | no trial data cached |
| Lymphoma transformation | 39 | 262.3 188.2–365.5ROR 263.3 · χ² 8,808 / p <1e-300 | 209.7 EB05 160.1 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=39 | no trial data cached |
| Diffuse large b-cell lymphoma stage iv | 26 | 189.2 126.7–282.4ROR 189.7 · χ² 4,299 / p <1e-300 | 154.3 EB05 110.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · ♀ 14% (drug 41%) | no trial data cached |
| Refractory cancer | 17 | 184.0 112.1–301.8ROR 184.3 · χ² 2,682 / p <1e-300 | 142.6 EB05 94.3 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial data cached |
| Cystitis viral | 23 | 138.9 91.1–211.7ROR 139.2 · χ² 2,828 / p <1e-300 | 117.9 EB05 82.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 10% (drug 41%) · 100% clinician | no trial data cached |
| Diffuse large b-cell lymphoma | 406 | 121.5 110.1–134.0ROR 126.7 · χ² 45,798 / p <1e-300 | 114.4 EB05 105.3 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 70.5 · 94% clinician | no trial data cached |
| Follicular lymphoma | 45 | 120.4 89.2–162.4ROR 120.9 · χ² 4,930 / p <1e-300 | 108.8 EB05 84.7 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=44 | no trial data cached |
| Candida pneumonia | 16 | 112.2 67.9–185.4ROR 112.4 · χ² 1,571 / p <1e-300 | 94.9 EB05 61.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Human polyomavirus infection | 21 | 91.0 58.8–140.8ROR 91.2 · χ² 1,707 / p <1e-300 | 81.1 EB05 56.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Retroperitoneal lymphadenopathy | 20 | 85.3 54.6–133.3ROR 85.4 · χ² 1,522 / p <1e-300 | 76.3 EB05 52.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=20 · 95% clinician | no trial data cached |
| Blood cholinesterase decreased | 10 | 81.4 43.3–153.0ROR 81.5 · χ² 689 / p 3e-152 | 68.6 EB05 39.8 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Hydroureter | 12 | 71.5 40.2–127.0ROR 71.5 · χ² 740 / p 3e-163 | 62.6 EB05 38.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Cytomegalovirus infection reactivation | 131 | 68.4 57.6–81.3ROR 69.3 · χ² 8,368 / p <1e-300 | 65.7 EB05 56.8 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=130 · 98% clinician | no trial data cached |
| Cytomegalovirus enterocolitis | 21 | 61.2 39.7–94.5ROR 61.4 · χ² 1,152 / p 9e-253 | 56.7 EB05 39.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 418 | 58.2 52.9–64.0ROR 60.7 · χ² 22,823 / p <1e-300 | 56.5 EB05 52.1 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 35.9 · 95% clinician | no trial data cached |
| Toxoplasmosis | 27 | 55.2 37.7–80.9ROR 55.4 · χ² 1,349 / p 1e-295 | 52.0 EB05 37.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 41%) · 100% clinician | no trial data cached |
| Lymphoma | 376 | 53.7 48.6–59.4ROR 55.9 · χ² 18,944 / p <1e-300 | 52.3 EB05 48.0 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 32.1 · 95% clinician | no trial data cached |
| Cytokine release syndrome | 438 | 50.8 46.3–55.8ROR 53.2 · χ² 20,873 / p <1e-300 | 49.6 EB05 45.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 · 97% clinician | no trial data cached |
| Abdominal lymphadenopathy | 18 | 46.3 29.0–73.8ROR 46.4 · χ² 737 / p 1e-162 | 43.4 EB05 29.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Blood bilirubin decreased | 12 | 42.6 24.1–75.5ROR 42.7 · χ² 438 / p 1e-97 | 39.4 EB05 24.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=8 | no trial data cached |
| Procalcitonin increased | 22 | 42.0 27.5–64.0ROR 42.1 · χ² 824 / p 2e-181 | 39.9 EB05 27.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
| Immune effector cell-associated neurotoxicity syndrome | 107 | 42.0 34.7–50.7ROR 42.4 · χ² 4,156 / p <1e-300 | 40.9 EB05 34.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=107 · 95% clinician | no trial data cached |
| Cytomegalovirus test positive | 33 | 41.0 29.1–57.9ROR 41.2 · χ² 1,225 / p 1e-268 | 39.4 EB05 29.4 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious n=33 · 100% clinician | no trial data cached |
| Neutropenic infection | 17 | 38.7 24.0–62.5ROR 38.7 · χ² 576 / p 1e-127 | 36.6 EB05 24.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Tumour flare | 12 | 38.6 21.8–68.4ROR 38.7 · χ² 396 / p 2e-88 | 36.0 EB05 21.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Disease progression | 2,020 | 37.7 36.2–39.2ROR 47.3 · χ² 71,195 / p <1e-300 | 37.0 EB05 35.7 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 25.3 · 95% clinician | no trial data cached |
| C-reactive protein decreased | 11 | 37.1 20.5–67.3ROR 37.1 · χ² 345 / p 2e-77 | 34.5 EB05 20.5 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Hypogammaglobulinaemia | 107 | 36.7 30.3–44.3ROR 37.1 · χ² 3,616 / p <1e-300 | 35.9 EB05 30.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=107 · 97% clinician | no trial data cached |
| Hypoproteinaemia | 30 | 35.6 24.8–51.0ROR 35.7 · χ² 958 / p 1e-210 | 34.3 EB05 25.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=29 · 93% clinician | no trial data cached |
| Cytopenia | 179 | 32.9 28.4–38.0ROR 33.5 · χ² 5,416 / p <1e-300 | 32.3 EB05 28.5 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.1 · 98% clinician | no trial data cached |
| Pseudomonal bacteraemia | 12 | 31.4 17.7–55.4ROR 31.4 · χ² 318 / p 2e-71 | 29.6 EB05 18.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Alanine aminotransferase decreased | 10 | 30.4 16.3–56.8ROR 30.4 · χ² 252 / p 4e-57 | 28.5 EB05 16.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=6 | no trial data cached |
| Hyperuricaemia | 53 | 28.3 21.6–37.1ROR 28.4 · χ² 1,350 / p 8e-296 | 27.7 EB05 22.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=53 · 96% clinician | no trial data cached |
| Lymphocyte count decreased | 222 | 27.5 24.1–31.3ROR 28.1 · χ² 5,567 / p <1e-300 | 27.1 EB05 24.2 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.4 · 99% clinician | no trial data cached |
| Pneumonia pseudomonal | 19 | 27.3 17.4–43.0ROR 27.4 · χ² 451 / p 3e-100 | 26.4 EB05 17.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Resorption bone increased | 10 | 26.7 14.3–49.8ROR 26.7 · χ² 219 / p 6e-50 | 25.1 EB05 14.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Ototoxicity | 22 | 25.9 17.0–39.5ROR 26.0 · χ² 497 / p 2e-110 | 25.1 EB05 17.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=22 | 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 |
|---|---|---|---|---|---|---|
| Disease progression | 2,020 | 37.7 36.2–39.2ROR 47.3 · χ² 71,195 / p <1e-300 | 37.0 EB05 35.7 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 25.3 · 95% clinician | no trial data cached |
| Off label use (used outside approved label) | 1,318 | 3.3 3.1–3.5ROR 3.6 · χ² 2,181 / p <1e-300 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 92% clinician | no trial data cached |
| Death | 783 | 2.0 1.8–2.1ROR 2.1 · χ² 386 / p 3e-86 | 2.0 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction | serious PRR 1.2 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 609 | 9.8 9.0–10.5ROR 10.3 · χ² 4,785 / p <1e-300 | 9.7 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 96% clinician | no trial data cached |
| Anaemia (low red blood cells) | 562 | 6.4 5.9–6.9ROR 6.7 · χ² 2,560 / p <1e-300 | 6.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 96% clinician | no trial data cached |
| Covid-19 | 534 | 6.5 6.0–7.1ROR 6.9 · χ² 2,514 / p <1e-300 | 6.5 EB05 6.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 96% clinician | no trial data cached |
| Febrile neutropenia | 529 | 17.4 16.0–18.9ROR 18.3 · χ² 8,119 / p <1e-300 | 17.3 EB05 16.1 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 · 98% clinician | no trial data cached |
| Pyrexia (fever) | 513 | 3.2 2.9–3.5ROR 3.3 · χ² 788 / p 1e-173 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Drug ineffective (drug did not work) | 490 | 0.8 0.7–0.9ROR 0.8 · χ² 25 / p 3e-7 | 0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.3 · 92% clinician | no trial data cached |
| Cytokine release syndrome | 438 | 50.8 46.3–55.8ROR 53.2 · χ² 20,873 / p <1e-300 | 49.6 EB05 45.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 30.3 · 97% clinician | no trial data cached |
| Platelet count decreased | 427 | 8.7 7.9–9.5ROR 9.0 · χ² 2,903 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 90% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 418 | 58.2 52.9–64.0ROR 60.7 · χ² 22,823 / p <1e-300 | 56.5 EB05 52.1 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 35.9 · 95% clinician | no trial data cached |
| Neutrophil count decreased | 410 | 22.1 20.1–24.3ROR 23.0 · χ² 8,165 / p <1e-300 | 21.9 EB05 20.1 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.8 · 99% clinician | no trial data cached |
| Diffuse large b-cell lymphoma | 406 | 121.5 110.1–134.0ROR 126.7 · χ² 45,798 / p <1e-300 | 114.4 EB05 105.3 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 70.5 · 94% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 401 | 7.8 7.1–8.6ROR 8.1 · χ² 2,373 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 · 98% clinician | 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.
- Cystitis viral — n=23, PRR 138.9
- Human polyomavirus infection — n=21, PRR 91.0
- Retroperitoneal lymphadenopathy — n=20, PRR 85.3
- Cytomegalovirus enterocolitis — n=21, PRR 61.2
- Toxoplasmosis — n=27, PRR 55.2
- Cytokine release syndrome — n=438, PRR 50.8
- Procalcitonin increased — n=22, PRR 42.0
- Immune effector cell-associated neurotoxicity syndrome — n=107, PRR 42.0
- Hypogammaglobulinaemia — n=107, PRR 36.7
- Hypoproteinaemia — n=30, PRR 35.6
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 Polatuzumab Vedotin?
In FDA FAERS, the most frequently co-reported reaction terms for Polatuzumab Vedotin are neutropenia, anaemia, covid-19, febrile neutropenia, pyrexia, cytokine release syndrome. 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 Polatuzumab Vedotin have an FDA boxed warning?
No. The FDA label retrieved for Polatuzumab Vedotin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Polatuzumab Vedotin 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 20a16ab2-f338-4abb-9dcd-254bd949a2bc, effective 20260824; matched on
openfda.generic_name.exact:"POLATUZUMAB VEDOTIN") - 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, fieldpatient.drug.openfda.generic_name.exact, 992 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.