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What the FDA labels say about taking them together

Ketoconazole and rilpivirine

Rilpivirine's FDA label of August 28, 2025 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name rilpivirine. The rilpivirine label: “Concomitant use of EDURANT or EDURANT PED with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine. …”

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

What does the ketoconazole label say about rilpivirine?

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

What does the rilpivirine label say about ketoconazole?

Rilpivirine label, drug interactions

Concomitant Drug Class/Drug Name: Azole Antifungal Agents: fluconazole itraconazole ketoconazole This interaction study has been performed with a dose higher than the recommended dose for EDURANT assessing the maximal effect on the coadministered drug. The dosing recommendation is applicable to the recommended doses of EDURANT once daily. posaconazole voriconazole; Effect on Concentration of Rilpivirine or Concomitant Drug: ↑ rilpivirine ↓ ketoconazole; Clinical Comment: Concomitant use of EDURANT or EDURANT PED with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A enzymes). …

Source: FDA drug label (EDURANT), Janssen Products, LP, effective August 28, 2025 (SPL set 03880372-2c68-45c6-a53a-f420c49541d6), 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

30Ketoconazole generic labelers
2Rilpivirine generic labelers
KetoconazoleRilpivirine
Labeled forFungal infectionsHIV
Boxed warningNoNo
Pharmacy cost (NADAC)$0.249 per gram 2% cream$48.04 per tablet 25 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?