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What the FDA labels say about taking them together

Ketoconazole and lurasidone

Lurasidone's FDA label of January 31, 2025 names ketoconazole in its contraindications section; the ketoconazole label PlainMeds reads does not name lurasidone. The lurasidone label: “Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone.”

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 lurasidone FDA label on DailyMed (effective January 31, 2025, Sumitomo Pharma America, Inc.).

What does the ketoconazole label say about lurasidone?

Ketoconazole's label (effective January 28, 2026) does not name lurasidone 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 lurasidone label say about ketoconazole?

Lurasidone label, contraindications

Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ( 7.1 )].

Lurasidone label, drug interactions

Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of LATUDA with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of LATUDA alone. Intervention: LATUDA should not be used concomitantly with strong CYP3A4 inhibitors [see Contraindications ()]. Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil

Source: FDA drug label (Latuda), NDA200603 (Sunovion Pharms Inc), as published by Sumitomo Pharma America, Inc., effective January 31, 2025 (SPL set afad3051-9df2-4c54-9684-e8262a133af8), 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

30Ketoconazole generic labelers
28Lurasidone generic labelers
KetoconazoleLurasidone
Labeled forFungal infectionsSchizophrenia, Bipolar disorder, Depression
Boxed warningNoYes
Pharmacy cost (NADAC)$0.249 per gram 2% cream$0.142 per tablet 20 mg tablet
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?