Dordaviprone and Ketoconazole Topical: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Ketoconazole Topical
Dordaviprone
No brand names on record
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.
What happens
An increased risk of QT interval prolongation, increased dordaviprone exposure and an increased risk of dordaviprone-related adverse reactions
Interaction Deep Dive
Coadministration of ketoconazole (a strong CYP3A4 inhibitor that may prolong the QT interval) with dordaviprone (a CYP3A4 substrate that are known to prolong the QT interval) is contraindicated as it may cause increased CYP3A4 substrates exposure, increasing the risk for QT interval prolongation and result in life-threatening ventricular tachyarrhythmias such as torsade de pointes1. If concomitant use of a strong CYP3A4 inhibitor cannot be avoided for adult and pediatric patients who weigh at least 52.5 kg, reduce the dose of dordaviprone from 625 mg to 375 mg once weekly. The recommended dosage for pediatric patients weighing less than 52.5 kg who are receiving strong CYP3A4 inhibitors has not been established. The recommended dosage for pediatric patients weighing less than 52.5 kg who are receiving strong CYP3A4 inhibitors has not been established. After discontinuation of a strong CYP3A4 inhibitor for 3 to 5 elimination half-lives, resume the dordaviprone dose that was taken prior to initiating the CYP3A4 inhibitor 2.
Why it happens (mechanism)
Additive QT interval prolongation; inhibition of CYP3A4-mediated metabolism of dordaviprone
Literature reports
1 report — tap to read
a) In drug interaction studies, dordaviprone Cmax is predicted to increase by 1.5-fold and AUC by 2.5-fold following concomitant administration of fluconazole or erythromycin (moderate CYP3A4 inhibitor) 2.
Common questions
Can I take Dordaviprone and Ketoconazole Topical together?
An increased risk of QT interval prolongation, increased dordaviprone exposure and an increased risk of dordaviprone-related adverse reactions Always confirm with your pharmacist or prescriber before making any change.
How serious is the Dordaviprone and Ketoconazole Topical interaction?
It is rated contraindicated. These should generally not be used together.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How strong is the evidence for this interaction?
The evidence is graded "theoretical". Predicted from the drugs' pharmacology; not yet confirmed in people.
Questions for your pharmacist
- Does my dose of Dordaviprone or Ketoconazole Topical 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: Ketoconazole oral tablet, ketoconazole oral tablet. Taro Pharmaceuticals U.S.A. Inc. (per DailyMed), Hawthorne, NY, 2024. DailyMed
- Product Information: MODEYSO(TM) oral capsules, dordaviprone oral capsules. Jazz Pharmaceuticals, Inc. (per manufacturer), Palo Alto, CA, 2025. DailyMed
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