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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ENFORTUMAB VEDOTIN-EJFV: 3,733 Adverse Event Reports & Safety Profile

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3,733
Total FAERS Reports
747 (20.0%)
Deaths Reported
1,149
Hospitalizations
3,733
As Primary/Secondary Suspect
135
Life-Threatening
44
Disabilities
Prescription
Status

FDA Application: 761137 ·

First Report: 20190201 · Latest Report: 20250911

What Are the Most Common ENFORTUMAB VEDOTIN-EJFV Side Effects?

#1 Most Reported
Rash
560 reports (15.0%)
#2 Most Reported
Neuropathy peripheral
410 reports (11.0%)
#3 Most Reported
Malignant neoplasm progression
410 reports (11.0%)

All ENFORTUMAB VEDOTIN-EJFV Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Rash 560 15.0% 53 172
Malignant neoplasm progression 410 11.0% 137 79
Neuropathy peripheral 410 11.0% 22 61
Fatigue 281 7.5% 33 79
Pruritus 260 7.0% 25 95
Diarrhoea 257 6.9% 46 114
Death 238 6.4% 238 46
Decreased appetite 230 6.2% 34 95
Off label use 193 5.2% 28 48
Alopecia 185 5.0% 19 48
Nausea 168 4.5% 18 79
Skin disorder 157 4.2% 26 80
Pyrexia 156 4.2% 32 94
Hyperglycaemia 148 4.0% 30 77
Taste disorder 142 3.8% 12 40
Weight decreased 134 3.6% 10 34
Malaise 118 3.2% 13 60
Asthenia 116 3.1% 20 53
Erythema 105 2.8% 16 48
Stevens-johnson syndrome 103 2.8% 42 70

Who Reports ENFORTUMAB VEDOTIN-EJFV Side Effects? Age & Gender Data

Gender: 26.6% female, 73.4% male. Average age: 71.6 years. Most reports from: JP. View detailed demographics →

Is ENFORTUMAB VEDOTIN-EJFV Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 4 1 1
2020 120 26 29
2021 96 16 34
2022 470 105 202
2023 398 92 147
2024 527 123 237
2025 576 125 229

View full timeline →

What Is ENFORTUMAB VEDOTIN-EJFV Used For?

IndicationReports
Transitional cell carcinoma 1,179
Product used for unknown indication 1,061
Bladder cancer 530
Transitional cell carcinoma metastatic 390
Ureteric cancer 106
Malignant neoplasm of renal pelvis 103
Metastatic carcinoma of the bladder 96
Bladder transitional cell carcinoma 68
Transitional cell cancer of the renal pelvis and ureter 58
Bladder cancer stage iv 24

ENFORTUMAB VEDOTIN-EJFV vs Alternatives: Which Is Safer?

ENFORTUMAB VEDOTIN-EJFV vs ENFORTUMAB VEDOTIN\ENFORTUMAB VEDOTIN-EJFV ENFORTUMAB VEDOTIN-EJFV vs ENFUVIRTIDE ENFORTUMAB VEDOTIN-EJFV vs ENOXAPARIN ENFORTUMAB VEDOTIN-EJFV vs ENOXAPARIN - WINTHROP ENFORTUMAB VEDOTIN-EJFV vs ENSIFENTRINE ENFORTUMAB VEDOTIN-EJFV vs ENTACAPONE ENFORTUMAB VEDOTIN-EJFV vs ENTECAVIR ENFORTUMAB VEDOTIN-EJFV vs ENTINOSTAT ENFORTUMAB VEDOTIN-EJFV vs ENTRECTINIB ENFORTUMAB VEDOTIN-EJFV vs ENZALUTAMIDE

Official FDA Label for ENFORTUMAB VEDOTIN-EJFV

Official prescribing information from the FDA-approved drug label.