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FLUOROURACIL
FLUOROURACIL is a Nucleoside Metabolic Inhibitor [EPC] drug. It is currently FDA-approved (first approved 1962) for Actinic or Solar Keratoses, Superficial Basal Cell Carcinomas.
Fluorouracil is a marketed drug primarily indicated for the treatment of Actinic or Solar Keratoses. Its key composition patent is set to expire in 2028, providing a period of exclusivity that supports its market position. The primary risk is the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | FLUOROURACIL |
|---|---|
| Drug class | Nucleoside Metabolic Inhibitor [EPC] |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1962 |
Approved indications
- Actinic or Solar Keratoses
- Superficial Basal Cell Carcinomas
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Mucositis
- Myelosuppression
- Palmar-plantar erythrodysesthesia
- Gastrointestinal ulceration
- Dry skin
- Fissuring
- Photosensitivity
- Vein pigmentation
- Headache
Serious adverse events
- Dihydropyrimidine Dehydrogenase (DPD) Deficiency
- Cardiotoxicity
- Hyperammonemic encephalopathy
- Neurologic toxicity
- Pancytopenia
- Anaphylaxis
- Generalized allergic reactions
- Nystagmus
- Lacrimal duct stenosis
- Photophobia
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial (PHASE2)
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer (PHASE2)
- Neoadjuvant mFolfirinox With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma (PANDAS-PRODIGE 44) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial (PHASE2)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FLUOROURACIL CI brief — competitive landscape report
- FLUOROURACIL updates RSS · CI watch RSS
Frequently asked questions about FLUOROURACIL
What is FLUOROURACIL?
What is FLUOROURACIL used for?
What drug class is FLUOROURACIL in?
When was FLUOROURACIL approved?
What development phase is FLUOROURACIL in?
What are the side effects of FLUOROURACIL?
Related
- Drug class: All Nucleoside Metabolic Inhibitor [EPC] drugs
- Indication: Drugs for Actinic or Solar Keratoses
- Indication: Drugs for Superficial Basal Cell Carcinomas
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing