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What the FDA labels say about taking them together

Ledipasvir/sofosbuvir and rosuvastatin

Ledipasvir/sofosbuvir's FDA label of December 26, 2024 names rosuvastatin in its drug interactions section, and rosuvastatin's label names ledipasvir/sofosbuvir too. The ledipasvir/sofosbuvir label: “Coadministration of HARVONI with rosuvastatin may significantly increase the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis. …”

Check it at the source: the ledipasvir/sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc); the rosuvastatin FDA label on DailyMed (effective September 4, 2026, ScieGen Pharmaceuticals, Inc.).

What does the ledipasvir/sofosbuvir label say about rosuvastatin?

Ledipasvir/sofosbuvir label, drug interactions

Concomitant Drug Class/Drug Name: HMG-CoA Reductase Inhibitors: rosuvastatin; Effect on Concentration ↓ = decrease, ↑ = increase: ↑ rosuvastatin; Clinical Comment: Coadministration of HARVONI with rosuvastatin may significantly increase the concentration of rosuvastatin, which is associated with increased risk of myopathy, including rhabdomyolysis. Coadministration of HARVONI with rosuvastatin is not recommended.

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 rosuvastatin label say about ledipasvir/sofosbuvir?

Rosuvastatin label, drug interactions

Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis with Rosuvastatin Tablets Sofosbuvir/velpatasvir/voxilaprevir or Ledipasvir/sofosbuvir Prevention or Management:

Source: FDA drug label (Crestor, NDA021366), AstraZeneca Pharmaceuticals LP, effective April 29, 2026 (SPL set 325a5d0e-9a72-4015-9fcd-1655fb504cee), via openFDA

Source: FDA drug label (Rosuvastatin), ScieGen Pharmaceuticals, Inc., effective September 4, 2026 (SPL set ee4933c5-0d97-494d-ac0f-2083e0100836), 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
45Rosuvastatin generic labelers
Ledipasvir/sofosbuvirRosuvastatin
Labeled forHepatitis CHeart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$0.0692 per tablet 40 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?