Vamorolone 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
Vamorolone
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
Increased vamorolone exposure and an increased risk of vamorolone-related adverse effects
Interaction Deep Dive
Coadministration of vamorolone with multiple doses of a strong CYP3A4 inhibitor (itraconazole) increased vamorolone Cmax and AUC by 8% and 44% respectively. Reduce the dosage of vamorolone in patients when strong CYP3A4 inhibitors are used concomitantly. The recommended dosage of vamorolone when administered with strong CYP3A4 inhibitors is 4 mg/kg taken orally once daily preferably with a meal, up to a maximum daily dosage of 200 mg for patients weighing more than 50 kg. Consider dosage titration based on individual tolerability1.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of vamorolone
Literature reports
1 report — tap to read
a) In the drug interaction studies, compared to administration of vamorolone alone, administration of vamorolone following multiple doses of a strong CYP3A4 inhibitor (itraconazole) increased vamorolone Cmax and AUC by 8% and 44% respectively 1.
Common questions
Can I take Vamorolone and Ketoconazole Topical together?
Increased vamorolone exposure and an increased risk of vamorolone-related adverse effects Always confirm with your pharmacist or prescriber before making any change.
How serious is the Vamorolone and Ketoconazole Topical 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 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 Vamorolone 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 (1)
- Product Information: AGAMREE(R) oral suspension, vamorolone oral suspension. Santhera Pharmaceuticals (USA) Inc (per FDA), Burlington, MA, 2023. DailyMed
Keep reading about Ketoconazole Topical
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