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What the FDA labels say about taking them together

Darifenacin and ketoconazole

Darifenacin's FDA label of February 10, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name darifenacin. The darifenacin label: “The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors.”

Check it at the source: the darifenacin FDA label on DailyMed (effective February 10, 2026, Torrent Pharmaceuticals Limited); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the darifenacin label say about ketoconazole?

Darifenacin label, drug interactions

The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone).

Source: FDA drug label (Darifenacin), Torrent Pharmaceuticals Limited, effective February 10, 2026 (SPL set e84f1ae3-b9a2-4a15-a299-c75373891cc1), via openFDA; the full label on DailyMed

What does the ketoconazole label say about darifenacin?

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

8Darifenacin generic labelers
30Ketoconazole generic labelers
DarifenacinKetoconazole
Labeled forOveractive bladderFungal infections
Boxed warningNoNo
Pharmacy cost (NADAC)$0.432 per tablet 15 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)

What next?