Last reviewed 2026-04-20 · How we verify

Carac (fluorouracil)

Carac (fluorouracil) is a nucleoside metabolic inhibitor small molecule developed by SPECTRUM PHARMS and currently owned by Extrovis. It targets aromatase and has been FDA-approved since 1962 for various cancer indications, including actinic keratosis, adenocarcinoma of the pancreas, and metastatic breast carcinoma. Carac is available as a generic medication with 23 manufacturers and is off-patent. Key safety considerations include its short half-life of 0.12 hours and moderate bioavailability of 28%. As an off-patent medication, Carac is widely available and used in clinical practice.

At a glance

Approved indications

• Actinic keratosis
• Adenocarcinoma of pancreas
• Malignant tumor of colon
• Malignant tumor of stomach
• Metastasis from malignant tumor of colon
• Metastatic Breast Carcinoma
• Small intestine cancer
• Superficial basal cell carcinoma

Common side effects

• Leukocytosis
• Ulceration
• Burning
• Crusting
• Allergic contact dermatitis
• Pruritus
• Scarring
• Rash
• Soreness
• Miscarriage
• Birth defect (ventricular septal defect)
• Emotional upset

Drug interactions

• CYP2C9 Substrates
• warfarin

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

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