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What the FDA labels say about taking them together

Irinotecan and ketoconazole

Irinotecan's FDA label of May 12, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name irinotecan. The irinotecan label: “Patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure to irinotecan and its active metabolite SN-38.”

Check it at the source: the irinotecan FDA label on DailyMed (effective May 12, 2026, Pharmacia & Upjohn Company LLC); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the irinotecan label say about ketoconazole?

Irinotecan label, drug interactions

Patients receiving concomitant ketoconazole, a CYP3A4 and UGT1A1 inhibitor, have increased exposure to irinotecan and its active metabolite SN-38.

Source: FDA drug label (Onivyde, NDA207793), Ipsen Biopharmaceuticals, Inc., effective March 3, 2025 (SPL set c8b58efa-1820-48a4-b70d-62918fc4abfc), via openFDA

Source: FDA drug label (Camptosar), NDA020571 (Pfizer Inc), as published by Pharmacia & Upjohn Company LLC, effective May 12, 2026 (SPL set e518dfc6-7e93-4fee-a66c-51e1ab71c056), via openFDA; the full label on DailyMed

What does the ketoconazole label say about irinotecan?

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

12Irinotecan generic labelers
30Ketoconazole generic labelers
IrinotecanKetoconazole
Labeled forColorectal cancerFungal infections
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$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?