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What the FDA labels say about taking them together

Etravirine and ketoconazole

Etravirine's FDA label of August 15, 2023 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name etravirine. The etravirine label: “Posaconazole, a potent inhibitor of CYP3A4, may increase plasma concentrations of etravirine. Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4. …”

Check it at the source: the etravirine FDA label on DailyMed (effective August 15, 2023, 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 etravirine label say about ketoconazole?

Etravirine label, drug interactions

Concomitant Drug Class/Drug Name: Antifungals: itraconazole ketoconazole posaconazole; Effect on Concentration of Etravirine or Concomitant Drug: ↑ etravirine ↓ itraconazole ↓ ketoconazole ↔ posaconazole; Clinical Comment: Posaconazole, a potent inhibitor of CYP3A4, may increase plasma concentrations of etravirine. Itraconazole and ketoconazole are potent inhibitors as well as substrates of CYP3A4. Concomitant systemic use of itraconazole or ketoconazole and INTELENCE may increase plasma concentrations of etravirine. Simultaneously, plasma concentrations of itraconazole or ketoconazole may be decreased by INTELENCE. …

Source: FDA drug label (Intelence), Janssen Products LP, effective August 15, 2023 (SPL set 6a9cbc29-9f15-4b24-8d86-206b82887f3d), via openFDA; the full label on DailyMed

What does the ketoconazole label say about etravirine?

Ketoconazole's label (effective January 28, 2026) does not name etravirine 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

5Etravirine generic labelers
30Ketoconazole generic labelers
EtravirineKetoconazole
Labeled forHIVFungal infections
Boxed warningNoNo
Pharmacy cost (NADAC)$9.94 per tablet 200 mg tablet$0.249 per gram 2% cream
Shortage nowA presentation being discontinuedNo 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?