Fluorouracil
Generic: FLUOROURACIL
Basic Information
Manufacturer
Alembic Pharmaceuticals Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
6b34cbf2-66f9-48a4-b41f-deb84ba8e8c4
Indications & Usage
1 INDICATIONS AND USAGE Fluorouracil is indicated for the treatment of patients with: Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum ( 1.1 ) Adenocarcinoma of the Breast ( 1.2 ) Gastric Adenocarcinoma ( 1.3 ) Pancreatic Adenocarcinoma ( 1.4 ) 1.1 Adenocarcinoma of the Colon and Rectum .
1.2 Adenocarcinoma of the Breast .
1.3 Gastric Adenocarcinoma .
1.4 Pancreatic Adenocarcinoma .
1.2 Adenocarcinoma of the Breast .
1.3 Gastric Adenocarcinoma .
1.4 Pancreatic Adenocarcinoma .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Serious Adverse Reactions from Dihydropyrimidine Dehydrogenase (DPD) Deficiency [see Warnings and Precautions ( 5.1 )] Cardiotoxicity [see Warnings and Precautions ( 5.2 )] Hyperammonemic encephalopathy [see Warnings and Precautions ( 5.3 )] Neurologic toxicity [see Warnings and Precautions ( 5.4 )] Diarrhea [see Warnings and Precautions ( 5.5 )] Palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions ( 5.6 )] Myelosuppression [see Warnings and Precautions ( 5.7 )] Mucositis [see Warnings and Precautions ( 5.8 )] Increased risk of elevated INR when administrated with warfarin [see Warnings and Precautions ( 5.9 )] To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.2 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 [see Warnings and Precautions ( 5.7 )] 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)
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.2 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 [see Warnings and Precautions ( 5.7 )] 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)