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What the FDA labels say about taking them together

Ledipasvir/sofosbuvir and warfarin

Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names warfarin in its drug interactions section; the warfarin label PlainMeds reads does not name ledipasvir/sofosbuvir. The ledipasvir/sofosbuvir label: “Frequent monitoring of relevant laboratory parameters or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index is recommended to ensure safe and effective use.”

Check it at the source: the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc); the warfarin FDA label on DailyMed (effective May 29, 2026, Amneal Pharmaceuticals LLC).

What does the ledipasvir/sofosbuvir label say about warfarin?

Ledipasvir/sofosbuvir label, drug interactions

Frequent monitoring of relevant laboratory parameters (e.g., International Normalized Ratio [INR] in patients taking warfarin, blood glucose levels in diabetic patients) or drug concentrations of concomitant medications such as cytochrome P450 substrates with a narrow therapeutic index (e.g., certain immunosuppressants) is recommended to ensure safe and effective use.

Source: FDA drug label (Harvoni), Gilead Sciences, Inc, effective December 26, 2024 (SPL set f4ec77e4-bae8-4db0-b3d5-bde09c5fa075), via openFDA; the full label on DailyMed

What does the warfarin label say about ledipasvir/sofosbuvir?

Warfarin's label (effective May 29, 2026) does not name ledipasvir/sofosbuvir 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

0Ledipasvir/sofosbuvir generic labelers
19Warfarin generic labelers
Ledipasvir/sofosbuvirWarfarin
Labeled forHepatitis CBlood clots (DVT and PE), Atrial fibrillation
Boxed warningYesYes
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?