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Active Pharma Ingredients / 05 Nov 2026

Gimeracil

Generic Name: Gimeracil

small molecule; dihydropyrimidine dehydrogenase inhibitor used in fluoropyrimidine combinations; component of S-1/Teysuno in some regions.

ABSTRACT

Gimeracil is a small-molecule API. It is described as dihydropyrimidine dehydrogenase inhibitor used in fluoropyrimidine combinations; clinical use and safety vary by indication, regulatory status and product label.

DOSAGE

Not used as standalone therapy; dosage is according to tegafur/gimeracil/oteracil combination product label.

SIDE EFFECTS

  • Fluoropyrimidine-associated nausea, diarrhea or stomatitis in combinations
  • Myelosuppression in combination regimens
  • Fatigue or appetite decrease
  • Liver enzyme changes
  • Hand-foot syndrome or rash depending on regimen

ALLERGIC REACTIONS

(These symptoms may indicate an allergic reaction and require medical attention.)

  • Urticaria or generalized rash
  • Facial, lip, tongue or throat swelling
  • Bronchospasm, dyspnea or wheeze
  • Anaphylaxis (rare but serious)

DRUG INTERACTIONS

  • Concomitant fluoropyrimidines, brivudine/sorivudine analogs or DPD inhibitors can cause severe toxicity
  • Warfarin/anticoagulants may require closer monitoring with fluoropyrimidine regimens
  • Renal impairment may increase exposure in S-1 combinations

PRECAUTIONS

  • Assess renal function and fluoropyrimidine toxicity risks
  • Do not substitute standalone gimeracil for combination product guidance
  • Monitor CBC, GI toxicity and mucositis
  • Pregnancy/lactation risk assessment is required

WARNINGS

  • Severe fluoropyrimidine toxicity can be life-threatening
  • Contraindicated combinations must be checked before treatment
  • Not a standalone approved anticancer therapy

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