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  • Generic Name: fluorouracil injection
  • Brand Name: Adrucil
  • Drug Class: Antineoplastics, Antimetabolite
Last updated on MDtodate: 10/04/2022


The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Increased risk of serious or fatal adverse reactions in patients with low or absent dipyrimidine dehydrogenase activity.
  • Cardiotoxicity.
  • Hyperammonemic encephalopathy.
  • Neurologic toxicity.
  • Diarrhea.
  • Palmar-plantar erythrodysesthesia (hand-foot syndrome).
  • Myelosuppression.
  • Mucositis.
  • Increased risk of elevated INR when administrated with warfarin.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of fluorouracil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic: pancytopenia

Gastrointestinal: gastrointestinal ulceration, nausea, vomiting

Allergic Reactions: anaphylaxis and generalized allergic reactions

Neurologic: nystagmus, headache

Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation

Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia

Psychiatric: euphoria

Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails)



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