Trifluridine side effects: what 430 FDA adverse event reports show

Trifluridine · 18 reaction terms · 204 drug–reaction co-reports · data 2026-09-14

Drug class

Nucleoside Analog Antiviral, Nucleoside Metabolic Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

430 reports · 71% serious · 63 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Trifluridine Ophthalmic Solution is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.

FDA label, Indications and Usage

What it is

DESCRIPTION: Trifluridine Ophthalmic Solution (also known as trifluorothymidine, F 3 TdR, F 3 T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus.

FDA label, Description section

Boxed warning

None in the current 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 15 strongest signals

Reporting / coding artifact 4No label text to screen 11

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 3 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
Therapy partial responder	25	81.1 55.4–118.6ROR 86.0 · χ² 1,896 / p <1e-300	76.4 EB05 54.4 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 76.0 · 92% clinician	no trial data cached
Polyneuropathy	12	49.2 28.2–86.0ROR 50.6 · χ² 520 / p 3e-115	45.9 EB05 28.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.1	no trial data cached
Metastases to lung	10	42.3 22.9–78.0ROR 43.3 · χ² 363 / p 4e-81	39.3 EB05 22.8 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.3	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	18	37.6 23.9–59.0ROR 39.2 · χ² 605 / p 8e-134	36.2 EB05 24.2 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.2	no trial data cached
Haematotoxicity	7	36.8 17.7–76.8ROR 37.4 · χ² 209 / p 9e-48	33.5 EB05 17.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.5	no trial data cached
Neurotoxicity	12	33.7 19.3–58.9ROR 34.6 · χ² 349 / p 4e-78	32.1 EB05 19.5 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.5	no trial data cached
Drug resistance	17	32.3 20.3–51.5ROR 33.6 · χ² 485 / p 9e-108	31.3 EB05 20.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 27.5	no trial data cached
Metastases to liver	11	30.6 17.1–54.9ROR 31.4 · χ² 286 / p 2e-64	29.2 EB05 17.3 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.6	no trial data cached
Eye discharge	6	28.7 12.9–63.4ROR 29.0 · χ² 134 / p 3e-31	25.6 EB05 11.2 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Photosensitivity reaction (sun sensitivity)	9	26.7 14.0–50.9ROR 27.2 · χ² 198 / p 4e-45	25.1 EB05 13.7 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.1	no trial data cached
Eye pain	25	22.1 15.1–32.3ROR 23.4 · χ² 483 / p 2e-107	21.7 EB05 15.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2 · ♀ 64% (drug 43%) · 88% consumer	no trial data cached
Incorrect product storage	6	22.0 9.9–48.6ROR 22.3 · χ² 100 / p 8e-24	19.0 EB05 7.2 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Eye irritation	19	16.6 10.7–25.8ROR 17.3 · χ² 264 / p 1e-59	16.1 EB05 10.5 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	no trial data cached
Myelosuppression	7	10.0 4.8–20.9ROR 10.2 · χ² 48 / p 2e-12	7.2 EB05 3.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.1	no trial data cached
Product storage error	11	6.2 3.5–11.1ROR 6.3 · χ² 43 / p 3e-11	5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	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
Eye pain	25	22.1 15.1–32.3ROR 23.4 · χ² 483 / p 2e-107	21.7 EB05 15.4 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.2 · ♀ 64% (drug 43%) · 88% consumer	no trial data cached
Therapy partial responder	25	81.1 55.4–118.6ROR 86.0 · χ² 1,896 / p <1e-300	76.4 EB05 54.4 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	serious PRR 76.0 · 92% clinician	no trial data cached
Eye irritation	19	16.6 10.7–25.8ROR 17.3 · χ² 264 / p 1e-59	16.1 EB05 10.5 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	18	37.6 23.9–59.0ROR 39.2 · χ² 605 / p 8e-134	36.2 EB05 24.2 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.2	no trial data cached
Drug resistance	17	32.3 20.3–51.5ROR 33.6 · χ² 485 / p 9e-108	31.3 EB05 20.7 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 27.5	no trial data cached
Neurotoxicity	12	33.7 19.3–58.9ROR 34.6 · χ² 349 / p 4e-78	32.1 EB05 19.5 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.5	no trial data cached
Polyneuropathy	12	49.2 28.2–86.0ROR 50.6 · χ² 520 / p 3e-115	45.9 EB05 28.0 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 40.1	no trial data cached
Product storage error	11	6.2 3.5–11.1ROR 6.3 · χ² 43 / p 3e-11	5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Metastases to liver	11	30.6 17.1–54.9ROR 31.4 · χ² 286 / p 2e-64	29.2 EB05 17.3 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.6	no trial data cached
Metastases to lung	10	42.3 22.9–78.0ROR 43.3 · χ² 363 / p 4e-81	39.3 EB05 22.8 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.3	no trial data cached
Photosensitivity reaction (sun sensitivity)	9	26.7 14.0–50.9ROR 27.2 · χ² 198 / p 4e-45	25.1 EB05 13.7 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 34.1	no trial data cached
Myelosuppression	7	10.0 4.8–20.9ROR 10.2 · χ² 48 / p 2e-12	7.2 EB05 3.4 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.1	no trial data cached
Haematotoxicity	7	36.8 17.7–76.8ROR 37.4 · χ² 209 / p 9e-48	33.5 EB05 17.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.5	no trial data cached
Incorrect product storage	6	22.0 9.9–48.6ROR 22.3 · χ² 100 / p 8e-24	19.0 EB05 7.2 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=3	no trial data cached
Eye discharge	6	28.7 12.9–63.4ROR 29.0 · χ² 134 / p 3e-31	25.6 EB05 11.2 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	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 Trifluridine?

In FDA FAERS, the most frequently co-reported reaction terms for Trifluridine are eye pain, eye irritation, palmar-plantar erythrodysaesthesia syndrome, neurotoxicity, polyneuropathy, metastases to liver. 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 Trifluridine have an FDA boxed warning?

No. The FDA label retrieved for Trifluridine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Trifluridine 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 abc1d07f-91ee-4421-bc9b-457d0ed41f4c, effective 20240801; matched on openfda.generic_name.exact:"TRIFLURIDINE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
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, 18 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.