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What the FDA labels say about taking them together

Darunavir and rosuvastatin

Darunavir's FDA label of August 29, 2025 names rosuvastatin in its drug interactions section; the rosuvastatin labels PlainMeds reads (2) do not name darunavir. The darunavir label: “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 …”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the rosuvastatin FDA label on DailyMed (effective September 4, 2026, ScieGen Pharmaceuticals, Inc.).

What does the darunavir label say about rosuvastatin?

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

What does the rosuvastatin label say about darunavir?

Rosuvastatin's label (effective September 4, 2026) and its 1 other brand-application label do not name darunavir in these sections. A label lists what its studies and reports found; it is not a complete list.

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

13Darunavir generic labelers
45Rosuvastatin generic labelers
DarunavirRosuvastatin
Labeled forHIVHeart attack and coronary artery disease, High cholesterol, High triglycerides, Stroke prevention
Boxed warningNoNo
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$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?