Cariprazine and Clofazimine: Interaction Details
AI-assisted, pharmacist-reviewed · AI content regenerated Jul 16, 2026 · Source data updated Jul 16, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Clofazimine
No brand names on recordCariprazine
How we grade severity & evidence
Severity levels
- Contraindicated: These should generally not be used together.
- Major: Potentially serious — often needs a change or close monitoring.
- Moderate: Can be significant — usually manageable with monitoring.
- Minor: Usually limited clinical impact.
Evidence grades
- Established: Well documented — supported by controlled studies or strong clinical data.
- Probable: Good supporting evidence, though not definitively proven.
- Suspected: Some evidence suggests this interaction, but it is not well established.
- Possible: Limited or conflicting evidence; the interaction may occur.
- Theoretical: Predicted from the drugs' pharmacology; not yet confirmed in people.
Ratings come from the documented interaction literature and are reviewed by a pharmacist. They describe the documented risk of the combination, not what will necessarily happen to you — your dose, timing, and health picture all matter.
Here's what's going on: Your body uses an enzyme called CYP3A4 to break down cariprazine (Vraylar). Clofazimine slows that enzyme down. That means cariprazine and its active breakdown product can build up higher than usual in your body.
With more cariprazine around, you might notice more of its side effects, like restlessness, trouble sleeping, drowsiness, or muscle stiffness. The good news is this is very manageable. Don't stop or change either medicine on your own. Your care team can simply use a lower cariprazine dose while you're on clofazimine and keep a closer eye on how you feel.
Mechanism: Clofazimine is a moderate CYP3A4 inhibitor; cariprazine is a CYP3A4 substrate. Inhibition reduces clearance of cariprazine and its long-acting active metabolite didesmethylcariprazine (DDCAR), increasing exposure (AUC/Cmax).
Direction/effect: Increased cariprazine/DDCAR exposure, raising risk of dose-related effects (akathisia, EPS, insomnia, sedation). Evidence: probable; onset unspecified but note DDCAR's long half-life prolongs any effect.
Management (per labeling):
- New start on inhibitor: schizophrenia/bipolar mania begin 1.5 mg every other day; bipolar depression/adjunctive MDD use 1.5 mg every other day.
- Stable 1.5 or 3 mg/day: reduce to 1.5 mg every other day.
- Stable 4.5 or 6 mg/day: reduce to 1.5 mg once daily.
- On discontinuing clofazimine: may re-titrate cariprazine up per response/tolerability.
What happens
Increased cariprazine and its major active metabolite (didesmethylcariprazine (DDCAR)) exposure
Interaction Deep Dive
Taking cariprazine (a CYP3A4 substrate) together with a moderate CYP3A4 inhibitor can raise the exposure of cariprazine as well as its active metabolite, didesmethylcariprazine. If cariprazine is being started in a patient already receiving a moderate CYP3A4 inhibitor (for schizophrenia or bipolar mania), begin with 1.5 mg orally every other day; this may be raised to 1.5 mg orally every other day, if warranted and according to clinical response and tolerability. For patients on a moderate CYP3A4 inhibitor being treated for bipolar depression or receiving adjunctive therapy for MDD, give 1.5 mg orally every other day. When a moderate CYP3A4 inhibitor is being added to a patient already on a stable cariprazine dose: those currently receiving 1.5 or 3 mg once daily should have their cariprazine changed to 1.5 mg orally every other day upon starting the moderate inhibitor. Patients currently taking cariprazine 4.5 or 6 mg once daily should have their dose modified to 1.5 mg orally once daily when the moderate inhibitor is begun. Should the moderate CYP3A4 inhibitor be stopped, the cariprazine dose may require an increase guided by clinical response and tolerability1.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of cariprazine
How to manage this interaction
Keep taking both medicines as prescribed unless your prescriber tells you otherwise. This combination is manageable with a tailored dose.
Your care team typically handles this by:
- Using a lower cariprazine dose while you're also on clofazimine (for example, dosing less often or at a reduced amount, individualized to you).
- Watching you more closely for side effects like restlessness, stiffness, sleep changes, or drowsiness.
- Adjusting your cariprazine dose back up if clofazimine is later stopped.
What to do: Let your pharmacist or prescriber know you take both, and report any new or worsening side effects so they can fine-tune your dose.
Management is individual — confirm any change with your pharmacist or prescriber.
Literature reports
1 report — tap to read
a) In drug interaction studies, giving cariprazine 1.5 mg/day together with erythromycin (a moderate CYP3A4 inhibitor) 500 mg twice daily for 21 days led to an increase in cariprazine AUC (0 to 24 hours) and Cmax of roughly 50% 1. In one study that enrolled only White males receiving cariprazine 1.5 mg/day and erythromycin 500 mg twice daily (n=40), AUCs rose by 38% (cariprazine), 11% (desmethylcariprazine, an active metabolite), and 60% (didesmethylcariprazine, an active metabolite), while Cmax rose by 34%, 16%, and 62%, respectively. Coadministration with erythromycin did not affect Tmax 2.
Common questions
Can I take Cariprazine and Clofazimine together?
Clofazimine can raise cariprazine levels and its side effects, but your care team can safely manage this by lowering the cariprazine dose and monitoring you. Keep taking both as prescribed and report any new side effects. Always confirm with your pharmacist or prescriber before making any change.
How serious is the Cariprazine and Clofazimine interaction?
It is rated major. Potentially serious — often needs a change or close monitoring.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How is the Cariprazine and Clofazimine interaction managed?
Keep taking both medicines as prescribed unless your prescriber tells you otherwise. This combination is manageable with a tailored dose. Your care team typically handles this by: Using a lower cariprazine dose while you're also on clofazimine (for example, dosing less often or at a reduced amount, individualized to you). Watching you more closely for side effects like restlessness, stiffness, sle… Management is individual — always follow your own care team's guidance.
How strong is the evidence for this interaction?
The evidence is graded "probable". Good supporting evidence, though not definitively proven.
Questions for your pharmacist
- Does my dose of Cariprazine or Clofazimine need adjusting while I take them together?
- What symptoms should prompt me to call you or my prescriber right away?
- Does the timing of my doses matter for this combination?
- Is there a safer alternative to one of these medications for me?
References (2)
- Product Information: VRAYLAR(R) oral capsules, cariprazine oral capsules. AbbVie Inc. (per FDA), North Chicago, IL, 2024. DailyMed
- Szabo M, Hujber Z, Harsanyi J, et al: Coadministration of cariprazine with a moderate CYP3A4 inhibitor in patients with schizophrenia: implications for dose adjustment and safety monitoring. Clin Pharmacokinet 2024; 63(10):1501-1510. PubMed
Keep reading about Clofazimine
Keep reading about Cariprazine
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