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What the FDA labels say about taking them together

Ledipasvir/sofosbuvir and omeprazole

Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names omeprazole in its drug interactions section; the omeprazole labels PlainMeds reads (2) do not name ledipasvir/sofosbuvir.

Check it at the source: the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc); the omeprazole FDA label on DailyMed (effective April 22, 2024, Apotex Corp).

What does the ledipasvir/sofosbuvir label say about omeprazole?

Ledipasvir/sofosbuvir label, drug interactions

Concomitant Drug Class/Drug Name: Proton-pump inhibitors (e.g., omeprazole); Effect on Concentration ↓ = decrease, ↑ = increase: ↓ ledipasvir; Clinical Comment: Proton-pump inhibitor doses comparable to omeprazole 20 mg or lower can be administered simultaneously with HARVONI under fasted conditions.

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 omeprazole label say about ledipasvir/sofosbuvir?

Omeprazole's label (effective April 22, 2024) and its 1 other brand-application label do 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 (Omeprazole), Apotex Corp, effective April 22, 2024 (SPL set b83329ac-a65e-b3af-a3fb-c5a6c740e5e7), 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
118Omeprazole generic labelers
Ledipasvir/sofosbuvirOmeprazole
Labeled forHepatitis CAcid reflux and ulcers
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$0.0295 per capsule 20 mg capsule
Shortage nowNo current entryA presentation being discontinued

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

What next?