What the FDA labels say about taking them together
Ketoconazole and levoketoconazole
Levoketoconazole's FDA label of March 10, 2026 names ketoconazole in its boxed warning section; the ketoconazole label PlainMeds reads does not name levoketoconazole. The levoketoconazole label: “Anaphylaxis has been reported with oral ketoconazole Risks Related to Decreased Testosterone:”
Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the levoketoconazole FDA label on DailyMed (effective March 10, 2026, Xeris Pharmaceuticals, Inc.).
What does the ketoconazole label say about levoketoconazole?
Ketoconazole's label (effective January 28, 2026) does 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 (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
What does the levoketoconazole label say about ketoconazole?
Levoketoconazole label, boxed warningCases of hepatotoxicity with a fatal outcome or requiring liver transplantation have been reported with use of oral ketoconazole.
Levoketoconazole label, contraindicationsCONTRAINDICATIONS RECORLEV is contraindicated in patients: With cirrhosis, acute liver disease or poorly controlled chronic liver disease, baseline AST or ALT greater than 3 times the upper limit of normal, recurrent symptomatic cholelithiasis, a prior history of drug induced liver injury due to ketoconazole or any azole antifungal therapy that required discontinuation of treatment, or extensive metastatic liver disease [see Warnings and Precautions ( 5.1 )].
Levoketoconazole label, drug interactionsExamples H2-receptor antagonists and proton pump inhibitors Sucralfate Clinical Impact Impairs absorption of levoketoconazole from RECORLEV. Prevention or Management Avoid use of sucralfate with RECORLEV. Patients should be advised against excessive alcohol consumption while using RECORLEV [see Warnings and Precautions ( 5.1 )]. When used with alcohol cases of a disulfiram-like reaction have been reported with ketoconazole characterized by flushing, rash, peripheral edema, nausea, and headache. All symptoms completely resolved within a few hours.
Levoketoconazole label, warnings and precautionsAnaphylaxis 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
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
| Ketoconazole | Levoketoconazole | |
|---|---|---|
| Labeled for | Fungal infections | n/a |
| Boxed warning | No | Yes |
| Pharmacy cost (NADAC) | $0.249 per gram 2% cream | n/a |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once