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What the FDA labels say about taking them together

Capecitabine and fluorouracil

Capecitabine's FDA label of February 5, 2026 names fluorouracil in its contraindications section, and fluorouracil's label names capecitabine too. The capecitabine label: “CONTRAINDICATIONS XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine.”

Check it at the source: the capecitabine FDA label on DailyMed (effective February 5, 2026, H2-Pharma, LLC); the fluorouracil FDA label on DailyMed (effective January 19, 2026, Eugia US LLC).

What does the capecitabine label say about fluorouracil?

Capecitabine label, contraindications

CONTRAINDICATIONS XELODA is contraindicated in patients with history of severe hypersensitivity reaction to fluorouracil or capecitabine [see Adverse Reactions (6.1) ].

Capecitabine label, drug interactions

Leucovorin The concentration of fluorouracil is increased and its toxicity may be enhanced by leucovorin, folic acid, or folate analog products.

Source: FDA drug label (XELODA), NDA020896 (Cheplapharm), as published by H2-Pharma, LLC, effective February 5, 2026 (SPL set e702d84d-7162-4751-bf37-d724cc7e45a5), via openFDA; the full label on DailyMed

What does the fluorouracil label say about capecitabine?

Fluorouracil label, drug interactions

While pharmacokinetic data are not available to assess the effect of fluorouracil administration on warfarin pharmacokinetics, the elevation of coagulation times that occurs with the fluorouracil prodrug capecitabine is accompanied by an increase in warfarin concentrations.

Source: FDA drug label (FLUOROURACIL), Eugia US LLC, effective January 19, 2026 (SPL set 697816ce-dc05-4943-b7f0-2f0b125e93b7), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

18Capecitabine generic labelers
18Fluorouracil generic labelers
CapecitabineFluorouracil
Labeled forColorectal cancer, Breast cancerColorectal cancer
Boxed warningYesYes
Pharmacy cost (NADAC)$0.456 per tablet 500 mg tablet$0.616 per gram 5% cream
Shortage nowNo current entryNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?