Brentuximab Vedotin side effects: what 10,190 FDA adverse event reports show
Drug class
CD30-directed Immunoconjugate
Brand names
Adcetris
Who reports
10,190 reports · 91% serious · 1,938 with death outcome · 42% female
Used for
ADCETRIS is a CD30-directed antibody and microtubule inhibitor conjugate indicated for treatment of: • Adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine ( 1.1 ).
What it is
ADCETRIS (brentuximab vedotin) is a CD30-directed antibody and microtubule inhibitor conjugate consisting of three components: 1) the chimeric IgG1 antibody cAC10, specific for human CD30, 2) the microtubule disrupting agent MMAE, and 3) a protease-cleavable linker that covalently attaches MMAE to cAC10.
Boxed warning
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9) , Adverse Reactions (6.1) ] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete boxed warning.
Causality screen of the 40 strongest signals
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. 959 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Peripheral blood stem cell apheresis | 10 | 3,382.8 1,229.7–9,306.0ROR 3,386.1 · χ² 11,441 / p <1e-300 | 369.7 EB05 214.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Anaplastic large cell lymphoma t- and null-cell types recurrent | 15 | 2,341.9 1,114.6–4,920.6ROR 2,345.4 · χ² 15,227 / p <1e-300 | 454.5 EB05 292.4 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Adrenal infarction | 14 | 2,185.8 1,027.7–4,649.0ROR 2,188.8 · χ² 13,687 / p <1e-300 | 430.8 EB05 272.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Anaplastic large-cell lymphoma | 86 | 1,163.7 893.3–1,515.9ROR 1,173.6 · χ² 62,763 / p <1e-300 | 634.8 EB05 529.9 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=85 | no trial data cached |
| Haematopoietic stem cell mobilisation | 16 | 691.0 391.9–1,218.1ROR 692.0 · χ² 7,717 / p <1e-300 | 318.9 EB05 208.2 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Anaplastic large cell lymphoma t- and null-cell types | 54 | 493.7 366.9–664.3ROR 496.3 · χ² 20,963 / p <1e-300 | 348.2 EB05 277.0 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=54 | no trial data cached |
| Peripheral t-cell lymphoma unspecified | 92 | 383.4 307.1–478.7ROR 386.9 · χ² 29,196 / p <1e-300 | 302.4 EB05 254.0 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=89 · 95% clinician | no trial data cached |
| Cutaneous t-cell lymphoma recurrent | 10 | 383.0 194.9–752.5ROR 383.3 · χ² 2,892 / p <1e-300 | 199.9 EB05 116.1 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Peripheral t-cell lymphoma unspecified recurrent | 10 | 356.1 181.9–697.1ROR 356.4 · χ² 2,718 / p <1e-300 | 192.4 EB05 111.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Angioimmunoblastic t-cell lymphoma | 35 | 260.2 183.1–369.8ROR 261.1 · χ² 7,783 / p <1e-300 | 205.0 EB05 154.1 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious n=35 · 91% clinician | no trial data cached |
| Cancer fatigue | 16 | 156.1 93.9–259.5ROR 156.4 · χ² 2,148 / p <1e-300 | 124.0 EB05 80.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Congenital aplasia | 19 | 144.4 90.7–229.9ROR 144.7 · χ² 2,394 / p <1e-300 | 119.1 EB05 80.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Beta 2 microglobulin increased | 14 | 116.5 68.0–199.5ROR 116.6 · χ² 1,408 / p <1e-300 | 96.1 EB05 60.9 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Adult t-cell lymphoma/leukaemia | 24 | 112.2 74.4–169.2ROR 112.5 · χ² 2,403 / p <1e-300 | 98.3 EB05 69.5 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · 92% clinician | no trial data cached |
| Acute polyneuropathy | 13 | 99.9 57.3–174.4ROR 100.1 · χ² 1,121 / p 4e-246 | 83.9 EB05 52.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Peripheral motor neuropathy | 62 | 95.6 74.2–123.3ROR 96.2 · χ² 5,454 / p <1e-300 | 88.9 EB05 71.9 · IC025 +5.3 3/3 methods agree | Labeled — boxed warning exact term | serious n=50 | no trial data cached |
| Cutaneous t-cell lymphoma | 48 | 86.7 65.0–115.6ROR 87.1 · χ² 3,817 / p <1e-300 | 80.6 EB05 63.2 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=47 | no trial data cached |
| Peripheral sensorimotor neuropathy | 44 | 75.7 56.1–102.3ROR 76.1 · χ² 3,057 / p <1e-300 | 70.9 EB05 55.0 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=44 · 100% clinician | no trial data cached |
| Gamma-glutamyltransferase abnormal | 20 | 71.6 45.9–111.8ROR 71.7 · χ² 1,277 / p 5e-280 | 65.1 EB05 44.5 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=20 · 100% clinician | no trial data cached |
| Cytomegalovirus chorioretinitis | 62 | 68.3 53.1–87.9ROR 68.7 · χ² 3,914 / p <1e-300 | 64.9 EB05 52.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 4% (drug 42%) · 90% clinician | no trial data cached |
| Ectropion | 10 | 63.4 33.8–119.0ROR 63.5 · χ² 537 / p 5e-119 | 55.4 EB05 32.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Acquired diaphragmatic eventration | 10 | 60.0 32.0–112.6ROR 60.1 · χ² 508 / p 8e-113 | 52.8 EB05 30.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Mycosis fungoides | 22 | 55.7 36.5–85.1ROR 55.9 · χ² 1,099 / p 3e-241 | 52.0 EB05 36.2 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=20 · 95% clinician | no trial data cached |
| Blood albumin abnormal | 13 | 53.5 30.9–92.8ROR 53.6 · χ² 603 / p 2e-133 | 48.7 EB05 30.3 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Blood lactate dehydrogenase abnormal | 17 | 53.3 33.0–86.3ROR 53.4 · χ² 800 / p 2e-176 | 49.3 EB05 32.6 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Peripheral sensory neuropathy | 145 | 52.3 44.4–61.6ROR 53.1 · χ² 7,069 / p <1e-300 | 50.7 EB05 44.2 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=140 · 91% clinician | no trial data cached |
| Hepatitis viral | 17 | 44.6 27.6–72.1ROR 44.7 · χ² 667 / p 3e-147 | 41.8 EB05 27.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Product temperature excursion issue | 94 | 41.6 33.9–50.9ROR 41.9 · χ² 3,607 / p <1e-300 | 40.4 EB05 34.0 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| T-cell lymphoma | 21 | 38.5 25.0–59.3ROR 38.6 · χ² 717 / p 3e-158 | 36.7 EB05 25.3 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=21 | no trial data cached |
| Polyneuropathy | 204 | 35.9 31.3–41.2ROR 36.6 · χ² 6,769 / p <1e-300 | 35.2 EB05 31.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 | no trial data cached |
| Ileal perforation | 11 | 34.6 19.1–62.7ROR 34.6 · χ² 320 / p 6e-72 | 32.3 EB05 19.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Tumour flare | 11 | 33.7 18.6–61.1ROR 33.7 · χ² 312 / p 5e-70 | 31.5 EB05 18.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Febrile bone marrow aplasia | 66 | 32.9 25.9–42.0ROR 33.2 · χ² 1,981 / p <1e-300 | 32.2 EB05 26.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=66 · 94% clinician | no trial data cached |
| Vasogenic cerebral oedema | 10 | 29.5 15.8–55.1ROR 29.5 · χ² 244 / p 3e-55 | 27.6 EB05 15.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 138 | 28.8 24.4–34.0ROR 29.2 · χ² 3,625 / p <1e-300 | 28.3 EB05 24.6 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 · 92% clinician | no trial data cached |
| Bicytopenia | 26 | 28.0 19.0–41.2ROR 28.1 · χ² 641 / p 9e-142 | 27.1 EB05 19.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 65% (drug 42%) | no trial data cached |
| Pneumocystis jirovecii infection | 15 | 27.1 16.3–45.1ROR 27.1 · χ² 347 / p 1e-77 | 26.0 EB05 16.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Chronic inflammatory demyelinating polyradiculoneuropathy | 18 | 26.4 16.6–42.1ROR 26.5 · χ² 410 / p 2e-91 | 25.5 EB05 17.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Blood alkaline phosphatase abnormal | 11 | 25.5 14.1–46.3ROR 25.6 · χ² 233 / p 8e-53 | 24.2 EB05 14.1 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Hypogonadism | 12 | 24.5 13.9–43.3ROR 24.6 · χ² 245 / p 2e-55 | 23.3 EB05 14.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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) | 1,340 | 3.2 3.0–3.3ROR 3.5 · χ² 2,085 / p <1e-300 | 3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Febrile neutropenia | 758 | 23.8 22.2–25.5ROR 25.7 · χ² 16,407 / p <1e-300 | 23.5 EB05 22.2 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.9 · 96% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 711 | 15.6 14.5–16.7ROR 16.7 · χ² 9,662 / p <1e-300 | 15.5 EB05 14.5 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.7 | no trial data cached |
| Pyrexia (fever) | 682 | 4.1 3.8–4.4ROR 4.3 · χ² 1,593 / p <1e-300 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 586 | 8.9 8.3–9.7ROR 9.4 · χ² 4,130 / p <1e-300 | 8.9 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 90% clinician | no trial data cached |
| Death | 574 | 1.4 1.3–1.5ROR 1.4 · χ² 60 / p 5e-15 | 1.4 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.9 | no trial data cached |
| Anaemia (low red blood cells) | 396 | 4.3 3.9–4.7ROR 4.4 · χ² 998 / p 3e-219 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Nausea | 393 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.317 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Diarrhoea (diarrhea) | 382 | 1.2 1.1–1.3ROR 1.2 · χ² 16 / p 4e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Thrombocytopenia (low platelets) | 380 | 7.0 6.4–7.8ROR 7.3 · χ² 1,964 / p <1e-300 | 7.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Drug ineffective (drug did not work) | 374 | 0.6 0.5–0.6ROR 0.6 · χ² 117 / p 1e-27 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 · 92% clinician | no trial data cached |
| Disease progression | 350 | 6.1 5.5–6.8ROR 6.3 · χ² 1,499 / p <1e-300 | 6.1 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 94% clinician | no trial data cached |
| Pneumonia (lung infection) | 321 | 2.0 1.8–2.3ROR 2.1 · χ² 173 / p 9e-40 | 2.0 EB05 1.9 · IC025 +0.8 | Labeled — boxed warning synonym match | serious PRR 1.3 | no trial data cached |
| Weight decreased (weight loss) | 318 | 2.3 2.1–2.6ROR 2.4 · χ² 247 / p 5e-56 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Vomiting | 302 | 1.3 1.2–1.5ROR 1.3 · χ² 24 / p 4e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | 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.
- Cytomegalovirus chorioretinitis — n=62, PRR 68.3
- Polyneuropathy — n=204, PRR 35.9
- Febrile bone marrow aplasia — n=66, PRR 32.9
- Bicytopenia — n=26, PRR 28.0
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 Brentuximab Vedotin?
In FDA FAERS, the most frequently co-reported reaction terms for Brentuximab Vedotin are febrile neutropenia, neuropathy peripheral, pyrexia, neutropenia, anaemia, nausea. 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 Brentuximab Vedotin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS [see Warnings and Precautions (5.9) , Adverse Reactions (6.1) ] . WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete boxed warning.
Do FAERS signals prove that Brentuximab 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 3904f8dd-1aef-3490-e48f-bd55f32ed67f, effective 20251111; matched on
openfda.generic_name.exact:"BRENTUXIMAB 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, 999 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.