Tisotumab Vedotin side effects: what 912 FDA adverse event reports show

Tisotumab Vedotin · Tivdak · 11 reaction terms · 325 drug–reaction co-reports · data 2026-09-14

Drug class

Tissue factor-directed antibody and microtubule inhibitor conjugate

FDA label, Indications wording

Brand names

Tivdak

openFDA label

Who reports

912 reports · 61% serious · 68 with death outcome · 97% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is a tissue factor-directed antibody and microtubule inhibitor conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. ( 1 )

FDA label, Indications and Usage

What it is

Tisotumab vedotin-tftv is a Tissue Factor (TF) directed antibody drug conjugate (ADC) comprised of a human anti-TF IgG1-kappa antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable vc (valine-citrulline) linker.

FDA label, Description section

Boxed warning

OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, i.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 10 strongest signals

Labeled — boxed warning 4Labeled adverse reaction 2Labeled (related wording) 1Reporting / coding artifact 1Not in label — unassessed 2

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.
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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Conjunctivitis	42	52.7 39.2–70.8ROR 55.2 · χ² 2,075 / p <1e-300	51.4 EB05 39.6 · IC025 +4.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 54.5 · 93% clinician	no trial data cached
Dry eye	51	24.2 18.6–31.6ROR 25.6 · χ² 1,114 / p 2e-244	24.0 EB05 19.0 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 30.4	no trial data cached
Eye discharge	10	22.5 12.2–41.7ROR 22.8 · χ² 185 / p 2e-42	21.3 EB05 11.8 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning exact term	serious n=5	no trial data cached
Hospice care	9	21.0 11.0–40.3ROR 21.2 · χ² 152 / p 3e-35	19.6 EB05 10.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Eye disorder	28	19.7 13.6–28.3ROR 20.2 · χ² 478 / p 3e-106	19.4 EB05 14.0 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.1	no trial data cached
Neuropathy peripheral (nerve damage in hands/feet)	74	18.0 14.5–22.4ROR 19.5 · χ² 1,176 / p 4e-258	17.9 EB05 14.7 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 19.8	no trial data cached
Malignant neoplasm progression	70	15.8 12.6–19.8ROR 17.0 · χ² 960 / p 4e-211	15.7 EB05 12.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 14.9 · 90% clinician	no trial data cached
Ocular discomfort	7	14.8 7.1–31.0ROR 14.9 · χ² 77 / p 9e-19	11.9 EB05 4.9 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Vaginal haemorrhage	20	10.8 7.0–16.7ROR 11.0 · χ² 169 / p 8e-39	9.8 EB05 6.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.9	no trial data cached
Neoplasm progression	11	7.2 4.0–13.0ROR 7.3 · χ² 53 / p 2e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Neuropathy peripheral (nerve damage in hands/feet)	74	18.0 14.5–22.4ROR 19.5 · χ² 1,176 / p 4e-258	17.9 EB05 14.7 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 19.8	no trial data cached
Malignant neoplasm progression	70	15.8 12.6–19.8ROR 17.0 · χ² 960 / p 4e-211	15.7 EB05 12.8 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 14.9 · 90% clinician	no trial data cached
Dry eye	51	24.2 18.6–31.6ROR 25.6 · χ² 1,114 / p 2e-244	24.0 EB05 19.0 · IC025 +3.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 30.4	no trial data cached
Conjunctivitis	42	52.7 39.2–70.8ROR 55.2 · χ² 2,075 / p <1e-300	51.4 EB05 39.6 · IC025 +4.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 54.5 · 93% clinician	no trial data cached
Eye disorder	28	19.7 13.6–28.3ROR 20.2 · χ² 478 / p 3e-106	19.4 EB05 14.0 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 19.1	no trial data cached
Vaginal haemorrhage	20	10.8 7.0–16.7ROR 11.0 · χ² 169 / p 8e-39	9.8 EB05 6.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.9	no trial data cached
Neoplasm progression	11	7.2 4.0–13.0ROR 7.3 · χ² 53 / p 2e-13	5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.4	no trial data cached
Eye discharge	10	22.5 12.2–41.7ROR 22.8 · χ² 185 / p 2e-42	21.3 EB05 11.8 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning exact term	serious n=5	no trial data cached
Hospice care	9	21.0 11.0–40.3ROR 21.2 · χ² 152 / p 3e-35	19.6 EB05 10.0 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Ocular discomfort	7	14.8 7.1–31.0ROR 14.9 · χ² 77 / p 9e-19	11.9 EB05 4.9 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Eye inflammation	3	7.3 2.4–22.6ROR 7.3 · χ² 11 / p 6e-4	4.0 EB05 1.5 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious n=2	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Tisotumab Vedotin?

In FDA FAERS, the most frequently co-reported reaction terms for Tisotumab Vedotin are neuropathy peripheral, dry eye, conjunctivitis, eye disorder, vaginal haemorrhage, neoplasm progression. 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 Tisotumab Vedotin have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: OCULAR TOXICITY • TIVDAK can cause severe ocular toxicities resulting in changes in vision, including severe vision loss, and corneal ulceration. [see Warnings and Precautions (5.1) ]. • Conduct an ophthalmic exam, i.

Do FAERS signals prove that Tisotumab 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 c9fe3f32-4219-466e-acb9-3f609b4f4df1, effective 20251120; matched on openfda.generic_name.exact:"TISOTUMAB 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, field patient.drug.openfda.generic_name.exact, 11 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.