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What the FDA labels say about taking them together

Darunavir and rivaroxaban

Darunavir's FDA label of August 29, 2025 names rivaroxaban in its drug interactions section; the rivaroxaban labels PlainMeds reads (2) do not name darunavir. The darunavir label: “Co-administration of PREZISTA/ritonavir and rivaroxaban is not recommended because it may lead to an increased bleeding risk.”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the rivaroxaban FDA label on DailyMed (effective September 10, 2026, Janssen Pharmaceuticals, Inc.).

What does the darunavir label say about rivaroxaban?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: rivaroxaban; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ rivaroxaban; Clinical Comment: Co-administration of PREZISTA/ritonavir and rivaroxaban is not recommended because it may lead to an increased bleeding risk.

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 rivaroxaban label say about darunavir?

Rivaroxaban's label (effective September 10, 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 (Xarelto), Janssen Pharmaceuticals, Inc., effective September 10, 2026 (SPL set 10db92f9-2300-4a80-836b-673e1ae91610), 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
20Rivaroxaban generic labelers
DarunavirRivaroxaban
Labeled forHIVAtrial fibrillation, Heart attack and coronary artery disease, Blood clots (DVT and PE), Stroke prevention
Boxed warningNoYes
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$0.650 per tablet 2.5 mg tablet
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?