Skip to main content

What the FDA labels say about taking them together

Atorvastatin and sofosbuvir

Atorvastatin's FDA label of April 15, 2024 names sofosbuvir in its drug interactions section; the sofosbuvir label PlainMeds reads does not name atorvastatin. The atorvastatin label: “… rhabdomyolysis have been reported with concomitant use of ledipasvir plus sofosbuvir with LIPITOR.”

Check it at the source: the atorvastatin FDA label on DailyMed (effective April 15, 2024, Viatris Specialty LLC); the sofosbuvir FDA label on DailyMed (effective December 26, 2024, Gilead Sciences, Inc.).

What does the atorvastatin label say about sofosbuvir?

Atorvastatin label, drug interactions

Anti-Viral Medications Clinical Impact: Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters (…). Cases of myopathy and rhabdomyolysis have been reported with concomitant use of ledipasvir plus sofosbuvir with LIPITOR. … nelfinavir, do not exceed LIPITOR 40 mg [see ]. • Consider the risk/benefit of concomitant use of ledipasvir plus sofosbuvir with LIPITOR. • Monitor all patients for signs and symptoms of myopathy particularly during initiation of therapy and during upward dose titration of either drug. …

Atorvastatin label, warnings and precautions

Cases of myopathy/rhabdomyolysis have been reported with atorvastatin co-administered with lipid modifying doses (>1 gram/day) of niacin, fibrates, colchicine, and ledipasvir plus sofosbuvir [see Adverse Reactions (6.1) ].

Source: FDA drug label (Atorvaliq, NDA213260), CMP Pharma, Inc., effective April 27, 2024 (SPL set 41fca2d8-7f3f-45b9-8974-81b89accc211), via openFDA

Source: FDA drug label (Lipitor), NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed

What does the sofosbuvir label say about atorvastatin?

Sofosbuvir's label (effective December 26, 2024) does not name atorvastatin in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Sovaldi), Gilead Sciences, Inc., effective December 26, 2024 (SPL set 80beab2c-396e-4a37-a4dc-40fdb62859cf), 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

59Atorvastatin generic labelers
0Sofosbuvir generic labelers
AtorvastatinSofosbuvir
Labeled forHigh cholesterol, Angina, High triglycerides, Heart attack and coronary artery diseaseHepatitis C
Boxed warningNoYes
Pharmacy cost (NADAC)$0.0228 per tablet 10 mg tabletn/a
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?