Prescription medicine
Enfortumab vedotin Brand names: Padcev
Enfortumab vedotin (Padcev) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the enfortumab vedotin FDA label on DailyMed (effective August 4, 2026); every enfortumab vedotin label on DailyMed.
Highlights of the record
FDA label of August 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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.
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.1 ), and Adverse Reactions ( 6.1 )]. WARNING: SERIOUS SKIN REACTIONS See full prescribing information for complete boxed warning.
PADCEV can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions. ( 2.2 ), ( 5.1 ),
Used for
From the label: indications and usagePADCEV ® , 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).
Forms and strengths
- 20 mg/2ml
- 30 mg/3ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,224 through July 30, 2026
What is enfortumab vedotin used for?
From the label: indications and usagePADCEV ® , 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). PADCEV ® , in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). […]
Source: FDA drug label (PADCEV EJFV), SEAGEN INC., effective August 4, 2026 (SPL set b5631d3e-4604-4363-8f20-11dfc5a4a8ed), via openFDA; the full label on DailyMed
What does the patient leaflet for enfortumab vedotin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about PADCEV?PADCEV may cause serious side effects, including: Skin reactions. Skin reactions including severe skin reactions have happened in people treated with PADCEV and may be more common when PADCEV is given with pembrolizumab. In some cases, these severe skin reactions have caused death. Most severe skin reactions occurred during the first cycle of treatment but may happen later. Your healthcare provider will monitor you, may stop your treatment with PADCEV completely or for a period of time (temporarily), may change your dose, and may prescribe medicines if you get skin reactions. Tell your healthcare provider right away if you develop any of these signs of a new or worsening skin reaction: • target lesions (skin reactions that look like rings) • rash or itching that continues to get worse • blistering or peeling of the skin • painful sores or ulcers in mouth or nose, throat, or genital area • fever or flu-like symptoms • swollen lymph nodes See “What are the possible side effects of PADCEV?” for more information about side effects.
Source: FDA drug label (PADCEV EJFV), SEAGEN INC., effective August 4, 2026 (SPL set b5631d3e-4604-4363-8f20-11dfc5a4a8ed), via openFDA; the full label on DailyMed
Is there a generic for enfortumab vedotin (Padcev)?
No generic enfortumab vedotin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the enfortumab vedotin label say about other medicines?
The enfortumab vedotin label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Pembrolizumab | warnings and precautions | Skin reactions occurred in 65% (all grades) of the 570 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC in clinical trials. |
Source: FDA drug label (PADCEV EJFV), SEAGEN INC., effective August 4, 2026 (SPL set b5631d3e-4604-4363-8f20-11dfc5a4a8ed), via openFDA; the full label on DailyMed
What do FAERS reports show for enfortumab vedotin?
The FDA Adverse Event Reporting System holds 7,224 reports that list enfortumab vedotin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,434 are coded as a death and 2,448 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (2,437, against a median of 221 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Enfortumab vedotin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other