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What the FDA labels say about taking them together

Darunavir and ketoconazole

Darunavir's FDA label of August 29, 2025 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name darunavir. The darunavir label: “… these antifungals. When co-administration is required, the daily dose of ketoconazole or itraconazole should not exceed 200 mg with monitoring for increased antifungal adverse events.”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the darunavir label say about ketoconazole?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: Antifungals: itraconazole, isavuconazole, ketoconazole, posaconazole; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ darunavir ↑ itraconazole ↑ isavuconazole ↑ ketoconazole ↔ posaconazole; Clinical Comment: Monitor for increased PREZISTA/ritonavir and/or antifungal adverse events with concomitant use of these antifungals. When co-administration is required, the daily dose of ketoconazole or itraconazole should not exceed 200 mg with monitoring for increased antifungal adverse events.

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 ketoconazole label say about darunavir?

Ketoconazole's label (effective January 28, 2026) does 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 (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), 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
30Ketoconazole generic labelers
DarunavirKetoconazole
Labeled forHIVFungal infections
Boxed warningNoNo
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$0.249 per gram 2% cream
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)

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