Drug · FAERS side-effect profile with label screen
Trifluridine and Tipiracil side effects: what 10,666 FDA adverse event reports show
Drug class
Nucleoside Analog Antiviral, Nucleoside Metabolic Inhibitor
FDA label (Established Pharmacologic Class) of the closest related product
Label matched
Trifluridine (Trifluridine)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
10,666 reports · 79% serious · 4,219 with death outcome · 42% 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 40 strongest signals
Reporting / coding artifact 3Lab value / disease marker 7Outcome field, not a reaction 1No label text to screen 29
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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 811 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Rectal cancer metastatic | 16 | 95.2 57.6–157.1ROR 95.3 · χ² 1,333 / p 4e-292 | 82.2 EB05 53.6 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Colorectal cancer metastatic | 74 | 65.7 52.2–82.8ROR 66.2 · χ² 4,499 / p <1e-300 | 62.6 EB05 51.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=74 | no trial data cached |
| Carcinoembryonic antigen increased | 50 | 52.2 39.5–69.1ROR 52.5 · χ² 2,397 / p <1e-300 | 50.0 EB05 39.4 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=28 | no trial data cached |
| Stoma site haemorrhage | 28 | 36.8 25.4–53.5ROR 36.9 · χ² 923 / p 5e-203 | 35.4 EB05 25.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=27 · ♀ 18% (drug 42%) | no trial data cached |
| Colon cancer metastatic | 28 | 34.9 24.0–50.6ROR 35.0 · χ² 872 / p 6e-192 | 33.6 EB05 24.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 | no trial data cached |
| Blood alkaline phosphatase abnormal | 15 | 33.4 20.1–55.7ROR 33.5 · χ² 433 / p 2e-96 | 31.7 EB05 20.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Disease progression | 1,794 | 30.4 29.1–31.7ROR 36.3 · χ² 50,407 / p <1e-300 | 29.9 EB05 28.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.6 | no trial data cached |
| Cytopenia | 175 | 29.2 25.2–33.9ROR 29.7 · χ² 4,671 / p <1e-300 | 28.7 EB05 25.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 | no trial data cached |
| Cancer pain | 35 | 27.2 19.5–37.9ROR 27.2 · χ² 844 / p 7e-186 | 26.5 EB05 19.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 | no trial data cached |
| Malignant ascites | 10 | 26.0 13.9–48.4ROR 26.0 · χ² 213 / p 2e-48 | 24.4 EB05 13.8 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Intra-abdominal fluid collection | 20 | 22.4 14.4–34.9ROR 22.5 · χ² 384 / p 8e-86 | 21.8 EB05 14.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · 90% consumer | no trial data cached |
| Biliary obstruction | 13 | 20.6 11.9–35.6ROR 20.7 · χ² 221 / p 2e-50 | 19.6 EB05 11.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Transfusion | 106 | 20.0 16.5–24.2ROR 20.2 · χ² 1,877 / p <1e-300 | 19.8 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 81% consumer | no trial data cached |
| Ureteric obstruction | 13 | 18.8 10.9–32.5ROR 18.8 · χ² 200 / p 1e-45 | 17.8 EB05 10.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Bile duct obstruction | 16 | 16.5 10.1–26.9ROR 16.5 · χ² 216 / p 4e-49 | 15.7 EB05 9.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Radiotherapy | 13 | 13.4 7.8–23.2ROR 13.4 · χ² 136 / p 8e-32 | 12.0 EB05 6.7 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Tumour haemorrhage | 16 | 11.1 6.8–18.1ROR 11.1 · χ² 136 / p 9e-32 | 9.8 EB05 5.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Hydronephrosis | 38 | 10.1 7.3–13.8ROR 10.1 · χ² 299 / p 2e-67 | 9.5 EB05 7.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Red blood cell count decreased | 145 | 10.0 8.5–11.8ROR 10.1 · χ² 1,161 / p 7e-255 | 9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 | no trial data cached |
| Obstruction | 19 | 9.4 6.0–14.7ROR 9.4 · χ² 133 / p 4e-31 | 8.2 EB05 5.4 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Rectal cancer | 14 | 9.0 5.3–15.2ROR 9.0 · χ² 91 / p 7e-22 | 7.5 EB05 4.5 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| White blood cell count decreased | 490 | 8.9 8.2–9.7ROR 9.3 · χ² 3,437 / p <1e-300 | 8.8 EB05 8.2 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 | no trial data cached |
| Product distribution issue | 40 | 8.9 6.5–12.1ROR 8.9 · χ² 272 / p 2e-61 | 8.3 EB05 6.3 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=34 · 92% consumer | no trial data cached |
| Large intestinal obstruction | 10 | 8.9 4.8–16.6ROR 8.9 · χ² 62 / p 2e-15 | 6.9 EB05 3.8 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Product dose omission in error | 114 | 8.4 7.0–10.1ROR 8.5 · χ² 731 / p 3e-161 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 19.2 · 91% consumer | no trial data cached |
| Blood count abnormal | 62 | 8.0 6.2–10.2ROR 8.0 · χ² 369 / p 2e-82 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Intestinal obstruction | 143 | 7.5 6.4–8.9ROR 7.6 · χ² 801 / p 1e-176 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Ascites | 110 | 7.4 6.1–8.9ROR 7.4 · χ² 598 / p 2e-132 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Small intestinal obstruction | 45 | 7.2 5.4–9.7ROR 7.3 · χ² 235 / p 3e-53 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Death | 3,086 | 7.1 6.9–7.3ROR 9.5 · χ² 16,693 / p <1e-300 | 7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.1 | no trial data cached |
| Terminal state | 23 | 6.8 4.5–10.2ROR 6.8 · χ² 107 / p 2e-25 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · 78% consumer | no trial data cached |
| Performance status decreased | 16 | 6.7 4.1–11.0ROR 6.8 · χ² 72 / p 8e-18 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Skin toxicity | 19 | 6.7 4.3–10.5ROR 6.7 · χ² 86 / p 7e-21 | 5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | no trial data cached |
| Colon cancer | 50 | 6.6 5.0–8.7ROR 6.6 · χ² 231 / p 1e-52 | 6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Tumour marker increased | 16 | 6.6 4.0–10.7ROR 6.6 · χ² 70 / p 4e-17 | 5.6 EB05 3.6 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Neutrophil count decreased | 132 | 6.4 5.4–7.6ROR 6.5 · χ² 598 / p 2e-132 | 6.3 EB05 5.4 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 | no trial data cached |
| Gastrointestinal toxicity | 15 | 6.3 3.8–10.4ROR 6.3 · χ² 61 / p 3e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Proctalgia | 20 | 6.1 4.0–9.5ROR 6.1 · χ² 81 / p 1e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Hyperbilirubinaemia | 32 | 6.1 4.3–8.7ROR 6.1 · χ² 132 / p 9e-31 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 · 90% clinician | no trial data cached |
| Cholangitis | 19 | 6.1 3.9–9.5ROR 6.1 · χ² 75 / p 2e-18 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | 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 |
|---|---|---|---|---|---|---|
| Death | 3,086 | 7.1 6.9–7.3ROR 9.5 · χ² 16,693 / p <1e-300 | 7.0 EB05 6.8 · IC025 +2.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.1 | no trial data cached |
| Disease progression | 1,794 | 30.4 29.1–31.7ROR 36.3 · χ² 50,407 / p <1e-300 | 29.9 EB05 28.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.6 | no trial data cached |
| Fatigue (tiredness) | 1,403 | 3.6 3.4–3.7ROR 3.9 · χ² 2,668 / p <1e-300 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial data cached |
| Nausea | 1,178 | 2.9 2.8–3.1ROR 3.2 · χ² 1,561 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | no trial data cached |
| Diarrhoea (diarrhea) | 1,020 | 3.1 2.9–3.3ROR 3.3 · χ² 1,512 / p <1e-300 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 682 | 5.8 5.4–6.2ROR 6.1 · χ² 2,729 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Vomiting | 633 | 2.7 2.5–2.9ROR 2.8 · χ² 666 / p 3e-147 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Asthenia (weakness) | 495 | 2.6 2.4–2.8ROR 2.7 · χ² 490 / p 8e-109 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| White blood cell count decreased | 490 | 8.9 8.2–9.7ROR 9.3 · χ² 3,437 / p <1e-300 | 8.8 EB05 8.2 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 | no trial data cached |
| Drug ineffective (drug did not work) | 365 | 0.5 0.5–0.6ROR 0.5 · χ² 148 / p 3e-34 | 0.5 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.4 | no trial data cached |
| Anaemia (low red blood cells) | 363 | 3.7 3.4–4.1ROR 3.8 · χ² 733 / p 1e-161 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 340 | 4.9 4.5–5.5ROR 5.1 · χ² 1,070 / p 6e-235 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | no trial data cached |
| Constipation | 339 | 3.1 2.8–3.4ROR 3.2 · χ² 479 / p 2e-106 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial data cached |
| Weight decreased (weight loss) | 334 | 2.4 2.1–2.6ROR 2.4 · χ² 262 / p 3e-59 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Dehydration | 325 | 4.8 4.3–5.3ROR 4.9 · χ² 977 / p 7e-215 | 4.8 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 · 72% consumer | 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 and Tipiracil?
In FDA FAERS, the most frequently co-reported reaction terms for Trifluridine and Tipiracil are fatigue, nausea, diarrhoea, decreased appetite, vomiting, asthenia. 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 and Tipiracil have an FDA boxed warning?
No. The FDA label retrieved for Trifluridine and Tipiracil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Trifluridine and Tipiracil 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, fieldpatient.drug.openfda.generic_name.exact, 851 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.