Skip to main content

What the FDA labels say about taking them together

Atorvastatin and darunavir

Atorvastatin's FDA label of April 15, 2024 names darunavir in its drug interactions section, and darunavir's label names atorvastatin too. The atorvastatin label: “Atorvastatin plasma levels were significantly increased with concomitant administration of LIPITOR with many anti-viral medications, which are inhibitors of CYP3A4 and/or transporters. …”

Check it at the source: the atorvastatin FDA label on DailyMed (effective April 15, 2024, Viatris Specialty LLC); the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP).

What does the atorvastatin label say about darunavir?

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. … the risk/benefit of concomitant use with atorvastatin. • In patients taking saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, fosamprenavir plus ritonavir, elbasvir plus grazoprevir or letermovir, do not exceed LIPITOR 20 mg. …

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 darunavir label say about atorvastatin?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: atorvastatin, pravastatin, rosuvastatin; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ HMG-CoA reductase inhibitors; Clinical Comment: Co-administration of PREZISTA/ritonavir with HMG-Co A reductase inhibitors may lead to adverse events such as myopathy. Titrate atorvastatin, pravastatin or rosuvastatin dose carefully and use the lowest necessary dose while monitoring for adverse events. Do not exceed atorvastatin 20 mg/day.

Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), 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
13Darunavir generic labelers
AtorvastatinDarunavir
Labeled forHigh cholesterol, Angina, High triglycerides, Heart attack and coronary artery diseaseHIV
Boxed warningNoNo
Pharmacy cost (NADAC)$0.0228 per tablet 10 mg tablet$1.16 per tablet 600 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?