What the label lists and what reports show
Tisotumab vedotin side effects
Tisotumab vedotin's FDA label: “The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, aspartate aminotransferase increased, epistaxis, alopecia, alanine …” FAERS holds 912 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 neuropathy peripheral (74 reports).
- No generic listed
- Boxed warning
Check it at the source: the tisotumab vedotin FDA label on DailyMed (effective November 20, 2025); 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 TIVDAK?TIVDAK can cause serious side effects, including: • See “ What is the most important information I should know about TIVDAK? ” • Peripheral neuropathy. Nerve problems called peripheral neuropathy are common with TIVDAK, and can also be serious. Tell your healthcare provider right away if you get numbness or tingling in your hands or feet or muscle weakness. • Bleeding (hemorrhage). Bleeding problems are common with TIVDAK, and can also be serious. Tell your healthcare provider or get medical help right away if you get signs or symptoms of bleeding during treatment with TIVDAK, including: o blood in your stools or black stools (looks like tar) o blood in your urine o cough up or vomit blood o unusual vaginal bleeding o any unusual or heavy bleeding • Lung problems. TIVDAK may cause severe or life-threatening inflammation of the lungs that can lead to death. […]
Source: FDA drug label, SEAGEN INC., effective November 20, 2025 (SPL set c9fe3f32-4219-466e-acb9-3f609b4f4df1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, aspartate aminotransferase increased, epistaxis, alopecia, alanine aminotransferase increased, and hemorrhage.
Table 6: Adverse Reactions (≥10%) in Patients Who Received TIVDAK in innovaTV 204
| Reaction | Adverse Reaction All Grades % | TIVDAK N=101 Grade 3-4 % |
|---|---|---|
| Fatigue Fatigue includes fatigue and asthenia | 50 | 7 |
| Pyrexia | 16 | 1 |
| Pruritus | 13 | 1 |
| Nausea Nausea includes nausea and retching | 41 | 0 |
| Diarrhea Diarrhea includes diarrhea, gastroenteritis, and colitis | 25 | 2 |
| Constipation | 23 | 2 |
| Abdominal pain Abdominal pain includes abdominal pain, abdominal pain upper, abdominal… | 23 | 1 |
| Vomiting | 17 | 2 |
| Peripheral neuropathy Peripheral neuropathy includes neuropathy peripheral, peripheral… | 39 | 7 |
| Alopecia | 39 | 0 |
| Rash Rash includes rash, rash maculo-papular, rash macular, dermatitis acneiform,… | 25 | 0 |
| Epistaxis | 39 | 0 |
| Hemorrhage Hemorrhage includes vaginal hemorrhage, hematuria, rectal hemorrhage, cystitis… | 32 | 6 |
| Conjunctival adverse reactions Conjunctival adverse reactions includes conjunctivitis,… | 37 | 0 |
| Dry eye Dry eye includes dry eye and lacrimation increased | 29 | 0 |
| Corneal adverse reactions Corneal adverse reactions includes keratitis, punctate… | 21 | 3 |
| Periorbital adverse reactions Periorbital adverse reactions includes blepharitis,… | 16 | 0 |
| Myalgia Myalgia includes myalgia, musculoskeletal discomfort, and musculoskeletal pain | 21 | 0 |
| Arthralgia | 16 | 0 |
| Pain in extremity Pain in extremity includes pain in extremity and limb discomfort | 13 | 1 |
| Decreased appetite | 16 | 1 |
| Urinary tract infection Urinary tract infection includes urinary tract infection, urinary… | 14 | 2 |
| Weight decreased | 12 | 0 |
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: • Ocular Adverse Reactions [see Boxed Warning, Warnings and Precautions (5.1) ] • Peripheral Neuropathy [see Warnings and Precautions (5.2) ] • Hemorrhage [see Warnings and Precautions (5.3) ] • Pneumonitis [see Warnings and Precautions (5.4) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] The most common (≥25%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased, peripheral neuropathy, conjunctival adverse reactions, nausea, fatigue, aspartate aminotransferase increased, epistaxis, alopecia, alanine aminotransferase increased, and hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Seagen Inc. at 1-855-4SEAGEN or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, SEAGEN INC., effective November 20, 2025 (SPL set c9fe3f32-4219-466e-acb9-3f609b4f4df1), via openFDA; the full label on DailyMed
What do FAERS reports show?
912 reports list tisotumab vedotin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 68 are coded as a death and 223 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. Of the 23 reactions below, 19 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?
- Tisotumab 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