What the label lists and what reports show
Enfortumab vedotin side effects
Enfortumab vedotin's FDA label: “The most common adverse reactions, including laboratory abnormalities, (≥20%) […]” FAERS holds 7,224 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is rash (945 reports).
- No generic listed
- Boxed warning
Check it at the source: the enfortumab vedotin FDA label on DailyMed (effective August 4, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of PADCEV?PADCEV may cause serious side effects, including: • See “What is the most important information I should know about PADCEV?” • High blood sugar (hyperglycemia). An increase in blood sugar is common during treatment with PADCEV. Severe high blood sugar, a serious condition called diabetic ketoacidosis (DKA), and death have happened in people with and without diabetes, treated with PADCEV. Tell your healthcare provider right away if you get any symptoms of high blood sugar, including: o frequent urination o increased thirst o blurred vision o confusion o it becomes harder to control your blood sugar o drowsiness o loss of appetite o fruity smell on your breath o nausea, vomiting, or stomach pain • Lung problems. PADCEV may cause severe or life-threatening inflammation of the lungs that can lead to death. […]
Source: FDA drug label, SEAGEN INC., effective August 4, 2026 (SPL set b5631d3e-4604-4363-8f20-11dfc5a4a8ed), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions, including laboratory abnormalities, (≥20%) […]
Table 11. Adverse Reactions ≥20% (All Grades) in Patients Treated with PADCEV in Combination with Intravenous Pembrolizumab in EV-103
| Reaction | Adverse Reaction All Grades Graded per NCI CTCAE v4.03. % | PADCEV in combination with intravenous pembrolizumab n=121 Grade 3-4 % |
|---|---|---|
| Rash Includes multiple terms. | 71 | 21 |
| Alopecia | 52 | 0 |
| Pruritus | 40 | 3.3 |
| Dry skin | 21 | 0.8 |
| Peripheral neuropathy | 65 | 3.3 |
| Dysgeusia | 35 | 0 |
| Dizziness | 23 | 0 |
| Fatigue | 60 | 11 |
| Peripheral edema | 26 | 0 |
| Decreased weight | 48 | 5 |
| Diarrhea | 45 | 7 |
| Nausea | 36 | 0.8 |
| Constipation | 27 | 0 |
| Decreased appetite | 38 | 0.8 |
| Urinary tract infection | 30 | 12 |
| Dry eye | 25 | 0 |
| Arthralgia | 23 | 1.7 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: • Skin Reactions [see Boxed Warning, Warnings and Precautions ( 5.1 )] • Hyperglycemia [see Warnings and Precautions ( 5.2 )] • Pneumonitis/Interstitial Lung Disease (ILD) [see Warnings and Precautions ( 5.3 )] • Peripheral Neuropathy [see Warnings and Precautions ( 5.4 )] • Ocular Disorders [see Warnings and Precautions ( 5.5 )] • Infusion Site Extravasation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions, including laboratory abnormalities, (≥20%) were: • PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: decreased hemoglobin, increased aspartate aminotransferase, increased alanine aminotransferase, rash, increased creatinine, decreased lymphocytes, fatigue, pruritus, decreased sodium, peripheral neuropathy, increased potassium, diarrhea, alopecia, dysgeusia, decreased appetite, nausea, constipation, urinary tract infection, dry eye, increased glucose, decreased weight, decreased potassium, hyperglycemia, decreased phosphate, and decreased neutrophils.
Source: FDA drug label, 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?
7,224 reports list enfortumab vedotin among the medicines taken, 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. Of the 22 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Enfortumab vedotin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions