Cariprazine and Ketoconazole interaction

Cariprazine and Ketoconazole: 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 Cariprazine (Vraylar) label · effective 2025-12-18

Moderate

Clinically Significant Drug Interactions with VRAYLAR Strong or Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of VRAYLAR with a strong or moderate CYP3A4 inhibitor increases the exposures of cariprazine and its major active metabolite, didesmethylcariprazine (DDCAR), compared to use of VRAYLAR alone [see Clinical Pharmacology ( 12.3 ) ].

Drug interactionsby drug classView label on DailyMed
Moderate

Intervention: If VRAYLAR is used with a strong or moderate CYP3A4 inhibitor, reduce VRAYLAR dosage [see D osage and A dministration ( 2.6 ) ] .

Drug interactionsby drug classView label on DailyMed
Moderate

Strong and Moderate CYP3A4 inhibitors: Reduce VRAYLAR dosage ( 2.6 , 7 )

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.