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What the FDA labels say about taking them together

Levoketoconazole and testosterone

Levoketoconazole's FDA label of March 10, 2026 names testosterone in its warnings and precautions section; the testosterone labels PlainMeds reads (4) do not name levoketoconazole. The levoketoconazole label: “Anaphylaxis has been reported with oral ketoconazole Risks Related to Decreased Testosterone:”

Check it at the source: the levoketoconazole FDA label on DailyMed (effective March 10, 2026, Xeris Pharmaceuticals, Inc.); the testosterone FDA label on DailyMed (effective July 25, 2025, Azurity Pharmaceuticals, Inc.).

What does the levoketoconazole label say about testosterone?

Levoketoconazole label, warnings and precautions

Anaphylaxis has been reported with oral ketoconazole ( 5.4 ) Risks Related to Decreased Testosterone:

Source: FDA drug label (Recorlev), NDA214133 (Strongbridge), as published by Xeris Pharmaceuticals, Inc., effective March 10, 2026 (SPL set d4c5fead-bc4a-fb02-e053-2a95a90ae4fc), via openFDA; the full label on DailyMed

What does the testosterone label say about levoketoconazole?

Testosterone's label (effective July 25, 2025) and its 3 other brand-application labels do not name levoketoconazole in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (AZMIRO), Azurity Pharmaceuticals, Inc., effective July 25, 2025 (SPL set 235b5625-570d-3fba-e063-6394a90aa2d1), 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

0Levoketoconazole generic labelers
33Testosterone generic labelers
LevoketoconazoleTestosterone
Labeled forn/aBreast cancer
Boxed warningYesNo
Pharmacy cost (NADAC)n/a$11.39 per mL 200 mg/mL
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?