Drug Interaction Report

Pitolisant and Ketoconazole Topical: Interaction Details

A pharmacist-reviewed analysis of the Pitolisant and Ketoconazole Topical interaction: the documented clinical effects, severity rating, onset, mechanism, and management considerations, with cited references throughout.

AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature

Ketoconazole Topical

Extina® Foam Ketozole® Cream Kuric Nizoral AD® Shampoo Nizoral® Cream Nizoral® Shampoo Xolegel®
+

Pitolisant

Wakix Wakix®
Dr. Brian Staiger, PharmD, BCPS
Medically reviewed by
Dr. Brian Staiger, PharmD, BCPS
Updated Aug 8, 2026
Editorial policy · Data sources
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Interaction severity
Contraindicated
These should generally not be used together.
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.

Of 97 documented Pitolisant interactions, 1 is rated contraindicated — including this one.
Worried about symptoms right now? Contact your pharmacist or prescriber, or call Poison Control at 1-800-222-1222 (US). Call 911 for an emergency.
Onset
unspecified
Evidence
theoretical
Severity
Contraindicated

What happens

Increased pitolisant exposure and an increased risk of QT interval prolongation

Interaction Deep Dive

Concomitant use of ketoconazole with pitolisant (a CYP3A4 substrate that prolongs QT) is contraindicated as it may lead to increased pitolisant exposure and prolonged QT interval1. Coadministration may also increase the risk of cardiac arrhythmias 2, and result in life-threatening ventricular tachyarrhythmias such as torsade de pointes 1.

Why it happens (mechanism)

Inhibition of CYP3A4-mediated metabolism of pitolisant; additive QT interval prolongation

Common questions

Can I take Pitolisant and Ketoconazole Topical together?

Increased pitolisant exposure and an increased risk of QT interval prolongation Always confirm with your pharmacist or prescriber before making any change.

How serious is the Pitolisant 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 Pitolisant 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)

  1. Product Information: Ketoconazole oral tablet, ketoconazole oral tablet. Taro Pharmaceuticals U.S.A. Inc. (per DailyMed), Hawthorne, NY, 2024. DailyMed
  2. Product Information: WAKIX® oral tablets, pitolisant oral tablets. Harmony Biosciences LLC (per FDA), Plymouth Meeting, PA, 2026. DailyMed
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Ketoconazole Topical

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Pitolisant

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All Pitolisant interactions (97) Pitolisant drug information
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This information is for education, not a substitute for professional medical advice. Do not start, stop, or change any medication without talking to your pharmacist or prescriber.