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What the FDA labels say about taking them together

Fosamprenavir and ketoconazole

Fosamprenavir's FDA label of September 15, 2023 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name fosamprenavir. The fosamprenavir label: “Increase monitoring for adverse events. Fosamprenavir: Dose reduction of ketoconazole or itraconazole may be needed for patients receiving more than 400 mg ketoconazole or itraconazole per day. …”

Check it at the source: the fosamprenavir FDA label on DailyMed (effective September 15, 2023, Mylan Pharmaceuticals Inc.); the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC).

What does the fosamprenavir label say about ketoconazole?

Fosamprenavir label, drug interactions

Concomitant Drug Class/Drug Name: Antifungals: Ketoconazole, itraconazole; Effect on Concentration of Amprenavir or Concomitant Drug: ↑ Ketoconazole ↑ Itraconazole; Clinical Comment: Increase monitoring for adverse events. Fosamprenavir: Dose reduction of ketoconazole or itraconazole may be needed for patients receiving more than 400 mg ketoconazole or itraconazole per day. Fosamprenavir/ritonavir: High doses of ketoconazole or itraconazole (greater than 200 mg/day) are not recommended.

Source: FDA drug label (Fosamprenavir Calcium), Mylan Pharmaceuticals Inc., effective September 15, 2023 (SPL set 3a1424d8-844c-4e24-9ebd-b2c2b61b61a3), via openFDA; the full label on DailyMed

What does the ketoconazole label say about fosamprenavir?

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

2Fosamprenavir generic labelers
30Ketoconazole generic labelers
FosamprenavirKetoconazole
Labeled forHIVFungal 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)

What next?