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What the FDA labels say about taking them together

Nitisinone and warfarin

Nitisinone's FDA label of November 30, 2021 names warfarin in its drug interactions section; the warfarin label PlainMeds reads does not name nitisinone. The nitisinone label: “Clinically Relevant Interactions Affecting Co-Administered Drugs Sensitive CYP2C9 Substrates or CYP2C9 Substrates with a Narrow Therapeutic Index Clinical Impact Increased exposure of the co-administered drugs …”

Check it at the source: the nitisinone FDA label on DailyMed (effective November 30, 2021, SWEDISH ORPHAN BIOVITRUM AB (PUBL)); the warfarin FDA label on DailyMed (effective May 29, 2026, Amneal Pharmaceuticals LLC).

What does the nitisinone label say about warfarin?

Nitisinone label, drug interactions

Clinically Relevant Interactions Affecting Co-Administered Drugs Sensitive CYP2C9 Substrates (e.g., celecoxib, tolbutamide) or CYP2C9 Substrates with a Narrow Therapeutic Index (e.g., phenytoin, warfarin) Clinical Impact Increased exposure of the co-administered drugs metabolized by CYP2C9. [see Clinical Pharmacology ( 12.3 )] Intervention Reduce the dosage of the co-administered drugs metabolized by CYP2C9 drug by half. Additional dosage adjustments may be needed to maintain therapeutic drug concentrations for narrow therapeutic index drugs. See prescribing information for those drugs.

Source: FDA drug label (Nityr, NDA209449), Cycle Pharmaceuticals Ltd., effective December 22, 2025 (SPL set 00fd1905-27e4-420e-8dc5-a69e4ddc1526), via openFDA

Source: FDA drug label (Orfadin), SWEDISH ORPHAN BIOVITRUM AB (PUBL), effective November 30, 2021 (SPL set 5d449b73-d503-4132-b978-d890491975df), via openFDA; the full label on DailyMed

What does the warfarin label say about nitisinone?

Warfarin's label (effective May 29, 2026) does not name nitisinone in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Warfarin Sodium), Amneal Pharmaceuticals LLC, effective May 29, 2026 (SPL set 558b7a0d-5490-4c1b-802e-3ab3f1efe760), 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

4Nitisinone generic labelers
19Warfarin generic labelers
NitisinoneWarfarin
Labeled forn/aBlood clots (DVT and PE), Atrial fibrillation
Boxed warningNoYes
Pharmacy cost (NADAC)n/a$0.093 per tablet 2 mg tablet
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?