Ketoconazole and Lumateperone interaction

Ketoconazole and Lumateperone: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Ketoconazole label · effective 2026-07-07

Major

This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents.

Contraindicationsby drug classView label on DailyMed
Major

…methadone when coadministered with ketoconazole tablets may increase the risk of serious cardiovascular events including QT prolongation and torsade de pointes, or respiratory or CNS depression [See CONTRAINDICATIONS .] Fentanyl: The potential increase in plasma concentrations of fentanyl when coadministered with ketoconazole tablets may increase the risk of…

Drug interactionsby drug classView label on DailyMed
Moderate

Antipsychotics, Anxiolytics and Hypnotics Lurasidone, alprazolam, oral midazolam, pimozide, triazolam aripiprazole, buspirone, haloperidol, midazolam IV, quetiapine, ramelteon, risperidone The increase in plasma concentrations of lurasidone when coadministered with ketoconazole tablets may increase the risk of serious side effects (See CONTRAINDICATIONS ).

Drug interactionsby drug classView label on DailyMed

From the Lumateperone (CAPLYTA) label · effective 2025-06-20

Moderate

Strong CYP3A4 inhibitors: Recommended dosage is 10.5 mg once daily.

Drug interactionsby drug classView label on DailyMed
Moderate

Moderate CYP3A4 inhibitors: Recommended dosage is 21 mg once daily.

Drug interactionsby drug classView label on DailyMed
Moderate

Moderate or Strong CYP3A4 Inhibitors* Prevention or Management Reduce the CAPLYTA dosage when used concomitantly with moderate or strong CYP3A4 inhibitors [see Dosage and Administration ( 2.2 ) ].

Drug interactionsby drug classView label on DailyMed
Moderate

Clinical Impact Concomitant use of CAPLYTA with moderate or strong CYP3A4 inhibitors increases lumateperone exposure [see Clinical Pharmacology ( 12.3 ) ] , which may increase the risk of adverse reactions.

Drug interactionsby drug classView label on DailyMed
No interaction

…interactions with adjunctive SSRI/SNRIs in MDD were observed in CAPLYTA clinical trials, CAPLYTA’s moderate serotonin transporter (SERT) activity may increase the risk of SRI-associated adverse reactions (e.g., serotonin syndrome, hyponatremia). * See www.fda.gov/CYPandTransporterInteractingDrugs for examples of CYP3A4 Inducers and Moderate or Strong CYP3A4 Inhibitors

Drug interactionsby drug classView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.