ADRUCIL SIDE EFFECTS

SIDE EFFECTS

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)