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What the label lists and what reports show

Trifluridine side effects

Trifluridine's FDA label lists its adverse reactions in its own words. FAERS holds 430 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 diarrhoea (47 reports).

  • Generic listed

Check it at the source: the trifluridine FDA label on DailyMed (effective August 1, 2024, Sandoz Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.

Source: FDA drug label, Sandoz Inc, effective August 1, 2024 (SPL set abc1d07f-91ee-4421-bc9b-457d0ed41f4c), via openFDA; the full label on DailyMed

What do FAERS reports show?

430 reports list trifluridine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 63 are coded as a death and 109 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 20 reactions below, none is 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.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)48
  • Diarrhoea47
  • Death (an outcome recorded in the report)39
  • Colorectal Cancer Metastatic31
  • Neutropenia30
  • Nausea29
  • Eye Pain25
  • Fatigue25
  • Therapy Partial Responder25
  • Off Label Use (a use or a product term, not a reaction)21
  • Vomiting21
  • Condition Aggravated (a use or a product term, not a reaction)20
  • Disease Progression (a use or a product term, not a reaction)20
  • Anaemia19
  • Eye Irritation19
  • Neuropathy Peripheral19
  • Pain19
  • Palmar-Plantar Erythrodysaesthesia Syndrome18
  • Drug Resistance17
  • Covid-1916
  • Hypertension16
  • Renal Failure15
  • Chronic Kidney Disease14
  • Malignant Neoplasm Progression13
  • Dizziness12

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Trifluridine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions