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What the FDA labels say about taking them together

Afatinib and ketoconazole

Afatinib's FDA label of November 13, 2025 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name afatinib. The afatinib label: “Increase GILOTRIF by 10 mg per day as tolerated. Effect of P-glycoprotein (P-gp) Inhibitors and Inducers Concomitant taking of P-gp inhibitors with GILOTRIF can increase exposure to afatinib.”

Check it at the source: the afatinib FDA label on DailyMed (effective November 13, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the afatinib label say about ketoconazole?

Afatinib label, drug interactions

Increase GILOTRIF by 10 mg per day as tolerated. ( 2.5 , 7 ) Effect of P-glycoprotein (P-gp) Inhibitors and Inducers Concomitant taking of P-gp inhibitors (including but not limited to ritonavir, cyclosporine A, ketoconazole, itraconazole, erythromycin, verapamil, quinidine, tacrolimus, nelfinavir, saquinavir, and amiodarone) with GILOTRIF can increase exposure to afatinib [see Clinical Pharmacology (12.3) ].

Source: FDA drug label (Gilotrif), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 13, 2025 (SPL set fd638e5e-8032-e7ca-0179-95e96ab5d387), via openFDA; the full label on DailyMed

What does the ketoconazole label say about afatinib?

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

1Afatinib generic labelers
30Ketoconazole generic labelers
AfatinibKetoconazole
Labeled forLung cancerFungal infections
Boxed warningNoNo
Pharmacy cost (NADAC)n/a$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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