Fluorouracil Injection, USP an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. Each 10 mL contains 500 mg fluorouracil; pH is adjusted to approximately 9.2 with sodium hydroxide.
Fluorouracil Injection, USP is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.
Published Studies Related to Fluorouracil
Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in
combination with salicylic acid treating actinic keratoses. 
practicability... CONCLUSIONS: Topical 0.5% 5-FU/SA demonstrated superior sustained clinical
A double-blind, randomized, placebo-controlled, phase 2 study of maintenance
enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line
therapy for metastatic colorectal cancer. 
maintenance therapy for metastatic colorectal cancer (MCRC)... CONCLUSIONS: Enzastaurin combined with bevacizumab-based therapy is tolerable,
Comparison of the efficacy of intralesional triamcinolone acetonide and
5-fluorouracil tattooing for the treatment of keloids. 
for treatment of keloids... CONCLUSION: 5-FU tattooing was more effective than intralesional TAC for the
Therapeutic efficacy of combination therapy with intra-arterial 5-fluorouracil and systemic pegylated interferon alpha-2b for advanced hepatocellular carcinoma with portal venous invasion. [2011.11.09]
BACKGROUND: The prognosis of advanced hepatocellular carcinoma (HCC) remains poor, particularly among patients with portal vein tumor thrombosis (PVTT). This study evaluated the efficacy of combined 5-fluorouracil and pegylated interferon (PEG-IFN) alpha-2b in patients with advanced HCC... CONCLUSIONS: Although a prospective randomized controlled trial using a larger population of patients with advanced HCC is needed to evaluate combination therapy with 5-fluorouracil and PEG-IFNalpha-2b, this new combination therapy may be useful for patients with advanced HCC. Cancer 2011;. (c) 2011 American Cancer Society. Copyright (c) 2011 American Cancer Society.
Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. [2011.11]
BACKGROUND: Actinic keratoses (AKs) arise after chronic sun exposure. Because long-term ultraviolet (UV) damage may induce proliferation of atypical keratinocytes, treatment of AKs is recommended. OBJECTIVES: To compare 5-fluorouracil 0.5%/salicylic acid 10.0% [low-dose 5-FU/SA (Actikerall(R))] with diclofenac 3% in hyaluronic acid (diclofenac HA) and vehicle for the treatment of AKs... CONCLUSIONS: Topical low-dose 5-FU/SA demonstrated higher histological and clinical clearance rates vs. diclofenac HA or vehicle. Low-dose 5-FU/SA is an effective lesion-directed treatment for AKs. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.
Clinical Trials Related to Fluorouracil
Definitive Chemoradiation With Gemcitabine and Continuous Fluorouracil (5- FU) Followed by High Dose Rate Brachytherapy or Stereotactic Body Radiation Therapy Boost in Locally Advanced Intra or Extrahepatic Cholangiocarcinoma [Recruiting]
OBJECTIVES: This study proposes to evaluate the feasibility of delivery of this treatment
in terms of toxicity. If toxicity is not acceptable, the treatment is not feasible.
- To establish a preliminary assessment whether toxicity rates are acceptable in patients
with locally advanced intra or extrahepatic cholangiocarcinoma when treated with a
regimen of gemcitabine every two weeks and continuous 5-FU given concurrently with
external beam radiation therapy to a total dose of 45 Gy, followed by a brachytherapy
or Stereotactic Body Radio Therapy (SBRT) boost.
- To evaluate the overall survival rate, progression free survival rate, tumor response
rate, local control rate and the rate of distant metastases following gemcitabine and
continuous 5-FU concurrent with radiation therapy in patients with locally advanced
intra or extrahepatic cholangiocarcinoma.
- To evaluate the rate at which patients with unresectable extrahepatic
cholangiocarcinoma become resectable following gemcitabine and radiation therapy.
A Dose Escalation Study of MK1775 in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005) [Recruiting]
The study evaluates safety of MK1775 in monotherapy, and in combination with 5-FU alone or
with 5-FU/CDDP in Japanese patients with solid tumor
Combination of Brivanib With 5-Fluorouracil/Leucovorin (5FU/LV) and 5-Fluorouracil/Leucovorin/Irinotecan (FOLFIRI) [Recruiting]
The purpose of this study is to determine a safe and maximum tolerable dose of Brivanib
when combined with standard dose 5FU/LV and FOLFIRI.
Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer [Recruiting]
The study is an open label, randomized phase 3 study of MM-398 with or without
5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and
leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine
Trametinib, Fluorouracil, and Radiation Therapy Before Surgery in Treating Patients With Stage II-III Rectal Cancer [Recruiting]
This phase I trial studies the side effects and best dose of trametinib when given together
with fluorouracil and radiation therapy before surgery in treating patients with stage
II-III rectal cancer. Trametinib may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
trametinib together with fluorouracil and radiation therapy before surgery may make the
tumor smaller and reduce the amount of normal tissue that needs to be removed
Reports of Suspected Fluorouracil Side Effects
Febrile Neutropenia (124),
Decreased Appetite (105),
Stomatitis (103), more >>