Enfortumab Vedotin side effects: what 7,224 FDA adverse event reports show
Drug class
Nectin-4-directed antibody and microtubule inhibitor conjugate
Brand names
Padcev Ejfv
Who reports
7,224 reports · 88% serious · 1,434 with death outcome · 24% female
Used for
PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC).
What it is
Enfortumab vedotin-ejfv is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 kappa monoclonal antibody (AGS-22C3) conjugated to the small molecule.
Boxed warning
SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions.
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.
- 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. 200 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 |
|---|---|---|---|---|---|---|
| Taste disorder | 242 | 35.5 31.3–40.2ROR 36.7 · χ² 7,982 / p <1e-300 | 35.0 EB05 31.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 42.2 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 156 | 30.3 25.9–35.5ROR 31.0 · χ² 4,353 / p <1e-300 | 29.9 EB05 26.2 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 19.3 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 203 | 26.7 23.3–30.6ROR 27.4 · χ² 4,951 / p <1e-300 | 26.4 EB05 23.5 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 17.3 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 852 | 26.4 24.8–28.1ROR 29.8 · χ² 20,692 / p <1e-300 | 26.1 EB05 24.7 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 20.1 | no trial data cached |
| Skin disorder | 291 | 25.6 22.9–28.7ROR 26.6 · χ² 6,804 / p <1e-300 | 25.3 EB05 23.0 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.2 · 96% clinician | no trial data cached |
| Therapy partial responder | 126 | 24.5 20.6–29.1ROR 24.9 · χ² 2,792 / p <1e-300 | 24.2 EB05 20.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.9 · 95% clinician | no trial data cached |
| Malignant neoplasm progression | 837 | 24.0 22.6–25.6ROR 27.1 · χ² 18,397 / p <1e-300 | 23.8 EB05 22.5 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 16.0 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 254 | 20.4 18.1–23.1ROR 21.1 · χ² 4,650 / p <1e-300 | 20.3 EB05 18.3 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.0 | no trial data cached |
| Adrenal insufficiency | 66 | 16.1 12.6–20.5ROR 16.2 · χ² 914 / p 4e-201 | 15.9 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 97% clinician | no trial data cached |
| Skin reaction | 71 | 14.7 11.7–18.6ROR 14.9 · χ² 890 / p 7e-196 | 14.5 EB05 11.9 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.7 | no trial data cached |
| Myelosuppression | 143 | 12.2 10.4–14.4ROR 12.5 · χ² 1,462 / p <1e-300 | 12.1 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 94% clinician | no trial data cached |
| Drug eruption | 72 | 11.9 9.5–15.0ROR 12.0 · χ² 706 / p 8e-156 | 11.7 EB05 9.5 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 90% clinician | no trial data cached |
| Metastases to lung | 46 | 11.6 8.7–15.5ROR 11.7 · χ² 434 / p 1e-96 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Interstitial lung disease | 190 | 11.5 10.0–13.2ROR 11.7 · χ² 1,800 / p <1e-300 | 11.3 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.5 · 95% clinician | no trial data cached |
| Erythema multiforme | 36 | 11.2 8.1–15.6ROR 11.3 · χ² 325 / p 6e-73 | 10.7 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 94% clinician | no trial data cached |
| Ileus | 46 | 10.9 8.2–14.5ROR 11.0 · χ² 402 / p 1e-89 | 10.5 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 91% clinician | no trial data cached |
| Pneumonitis | 101 | 10.9 9.0–13.2ROR 11.0 · χ² 894 / p 1e-196 | 10.7 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.4 | no trial data cached |
| Myocarditis | 41 | 10.5 7.8–14.3ROR 10.6 · χ² 344 / p 5e-77 | 10.1 EB05 7.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 95% clinician | no trial data cached |
| Metastases to liver | 58 | 9.6 7.4–12.4ROR 9.7 · χ² 439 / p 1e-97 | 9.3 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Hepatic function abnormal | 121 | 9.5 8.0–11.3ROR 9.6 · χ² 911 / p 2e-200 | 9.3 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 · 93% clinician | no trial data cached |
| Rash maculo-papular | 64 | 8.4 6.6–10.7ROR 8.5 · χ² 409 / p 2e-91 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Diabetic ketoacidosis | 69 | 8.4 6.6–10.6ROR 8.4 · χ² 440 / p 5e-98 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.5 | no trial data cached |
| Polyneuropathy | 34 | 8.3 5.9–11.6ROR 8.4 · χ² 211 / p 4e-48 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Colitis | 101 | 7.8 6.4–9.5ROR 7.9 · χ² 592 / p 6e-131 | 7.6 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hepatic cytolysis | 32 | 7.6 5.4–10.8ROR 7.6 · χ² 177 / p 1e-40 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 97% clinician | no trial data cached |
| Blood pressure systolic increased | 51 | 7.6 5.8–10.0ROR 7.6 · χ² 284 / p 5e-64 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 · 94% clinician | no trial data cached |
| Metastases to central nervous system | 30 | 6.8 4.8–9.7ROR 6.8 · χ² 143 / p 3e-33 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 93% clinician | no trial data cached |
| Cytokine release syndrome | 44 | 6.7 5.0–9.0ROR 6.8 · χ² 208 / p 2e-47 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 95% clinician | no trial data cached |
| Metastases to bone | 37 | 6.6 4.8–9.1ROR 6.6 · χ² 169 / p 6e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 22 | 6.4 4.2–9.7ROR 6.4 · χ² 95 / p 1e-22 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 95% clinician | no trial data cached |
| Rash | 945 | 6.3 6.0–6.7ROR 7.1 · χ² 4,323 / p <1e-300 | 6.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Blister | 122 | 6.3 5.3–7.6ROR 6.4 · χ² 543 / p 2e-120 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Neutrophil count decreased | 86 | 6.2 5.0–7.6ROR 6.2 · χ² 368 / p 3e-82 | 6.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Hepatitis (liver inflammation) | 54 | 6.1 4.7–8.0ROR 6.2 · χ² 227 / p 2e-51 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Multiple organ dysfunction syndrome | 58 | 6.0 4.7–7.8ROR 6.1 · χ² 239 / p 3e-54 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Mucosal inflammation | 54 | 6.0 4.6–7.9ROR 6.1 · χ² 221 / p 3e-50 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Toxic skin eruption | 20 | 5.8 3.7–8.9ROR 5.8 · χ² 74 / p 4e-18 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 · 90% clinician | no trial data cached |
| Poor venous access | 20 | 5.6 3.6–8.7ROR 5.6 · χ² 72 / p 1e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Lacrimation increased | 57 | 5.5 4.3–7.2ROR 5.6 · χ² 208 / p 2e-47 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Dry eye | 91 | 5.5 4.5–6.7ROR 5.5 · χ² 327 / p 2e-73 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.7 | 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 |
|---|---|---|---|---|---|---|
| Rash | 945 | 6.3 6.0–6.7ROR 7.1 · χ² 4,323 / p <1e-300 | 6.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 852 | 26.4 24.8–28.1ROR 29.8 · χ² 20,692 / p <1e-300 | 26.1 EB05 24.7 · IC025 +4.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 20.1 | no trial data cached |
| Malignant neoplasm progression | 837 | 24.0 22.6–25.6ROR 27.1 · χ² 18,397 / p <1e-300 | 23.8 EB05 22.5 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 16.0 | no trial data cached |
| Diarrhoea (diarrhea) | 468 | 2.1 1.9–2.3ROR 2.2 · χ² 282 / p 2e-63 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Pruritus (itching) | 419 | 3.2 2.9–3.5ROR 3.4 · χ² 650 / p 9e-144 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Fatigue (tiredness) | 404 | 1.5 1.4–1.7ROR 1.5 · χ² 72 / p 1e-17 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Death | 400 | 1.3 1.2–1.5ROR 1.4 · χ² 37 / p 5e-10 | 1.3 EB05 1.2 · IC025 +0.3 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.9 | no trial data cached |
| Decreased appetite (loss of appetite) | 396 | 5.0 4.5–5.5ROR 5.2 · χ² 1,264 / p 5e-277 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Alopecia (hair loss) | 307 | 4.5 4.1–5.1ROR 4.7 · χ² 849 / p 7e-187 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Skin disorder | 291 | 25.6 22.9–28.7ROR 26.6 · χ² 6,804 / p <1e-300 | 25.3 EB05 23.0 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.2 · 96% clinician | no trial data cached |
| Pyrexia (fever) | 282 | 2.4 2.1–2.7ROR 2.4 · χ² 224 / p 5e-51 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 254 | 20.4 18.1–23.1ROR 21.1 · χ² 4,650 / p <1e-300 | 20.3 EB05 18.3 · IC025 +4.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.0 | no trial data cached |
| Taste disorder | 242 | 35.5 31.3–40.2ROR 36.7 · χ² 7,982 / p <1e-300 | 35.0 EB05 31.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 42.2 | no trial data cached |
| Asthenia (weakness) | 210 | 1.6 1.4–1.9ROR 1.6 · χ² 50 / p 7e-13 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Malaise (feeling unwell) | 207 | 1.4 1.2–1.6ROR 1.4 · χ² 20 / p 3e-6 | 1.4 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.4 | 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.
- Taste disorder — n=242, PRR 35.5
- Adrenal insufficiency — n=66, PRR 16.1
- Myelosuppression — n=143, PRR 12.2
- Metastases to lung — n=46, PRR 11.6
- Erythema multiforme — n=36, PRR 11.2
- Ileus — n=46, PRR 10.9
- Metastases to liver — n=58, PRR 9.6
- Polyneuropathy — n=34, PRR 8.3
- Colitis — n=101, PRR 7.8
- Hepatic cytolysis — n=32, PRR 7.6
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 Enfortumab Vedotin?
In FDA FAERS, the most frequently co-reported reaction terms for Enfortumab Vedotin are rash, neuropathy peripheral, diarrhoea, pruritus, fatigue, decreased appetite. 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 Enfortumab Vedotin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS SKIN REACTIONS • PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later. • Closely monitor patients for skin reactions.
Do FAERS signals prove that Enfortumab 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 b5631d3e-4604-4363-8f20-11dfc5a4a8ed, effective 20260804; matched on
openfda.generic_name.exact:"ENFORTUMAB 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, 240 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.