Fluorouracil Cream, USP 5% is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite.
Fluorouracil Cream contains 5% fluorouracil in a vanishing cream base consisting of purified water, white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl).
Fluorouracil Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.
The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.
Media Articles Related to Fluorouracil
Teva Recalls Six More Lots of Fluorouracil Injection
Source: Medscape Hematology-Oncology Headlines [2015.07.27]
The recall of Adrucil is due to the potential presence of particulate matter identified as an aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.
Published Studies Related to Fluorouracil
Irsogladine maleate reduces the incidence of fluorouracil-based
chemotherapy-induced oral mucositis. 
mucositis through a double-blind, placebo controlled trial... CONCLUSION: IM significantly reduced the incidence and maximum severity of oral
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.
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
Panobinostat and Fluorouracil Followed By Leucovorin Calcium in Treating Patients With Stage IV Colorectal Cancer Who Did Not Respond to Previous Fluorouracil-Based Chemotherapy [Recruiting]
Panobinostat may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth. Drugs used in chemotherapy, such as fluorouracil and leucovorin calcium, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Giving panobinostat together with fluorouracil and leucovorin
calcium may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects
and the best dose of giving panobinostat, fluorouracil, and leucovorin calcium together in
treating patients with stage IV colorectal cancer who did not respond to previous
Reports of Suspected Fluorouracil Side Effects
Febrile Neutropenia (124),
Decreased Appetite (105),
Stomatitis (103), more >>