HomeRamelteonRamelteon + Ketoconazole

Does Ramelteon Interact with Ketoconazole?

Ramelteon and Ketoconazole have a moderate drug interaction according to U.S. FDA drug labeling data. ( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution. Ketoconazole (strong CYP3A4 inhibitor) The AUC 0-inf and C max of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with ramelteon. Ramelteon should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see Clinical Pharmacology (12.5) ] . Patients taking both medications should consult their healthcare provider before starting, stopping, or changing the dosage of either drug. This information is based on official FDA drug labeling sourced from OpenFDA and the NIH National Library of Medicine.

Severity
Moderate
Ramelteon Class
Melatonin Receptor Agonist
Ketoconazole Class
Azole Antifungal
Management
Monitor for effects
Data Source
U.S. FDA via OpenFDA

What To Tell Your Doctor or Pharmacist

If you are taking Ramelteon and your doctor is considering prescribing Ketoconazole (or vice versa), make sure to:

  • Inform your doctor and pharmacist of all current medications, including over-the-counter drugs and supplements
  • Ask whether the benefits of combining these medications outweigh the risks for your specific situation
  • Ask what symptoms to watch for that would indicate the interaction is causing problems
  • Ask whether any dosage adjustments are needed
  • Never stop or change either medication without first consulting your healthcare provider
💊 Ramelteon(Ramelteon)+💊 Ketoconazole

Severity & Interaction Details

🟡
moderate
Be aware — moderate interaction
Documented interaction with manageable risk. May require dose adjustment or monitoring.
Severity scale
MinorContra
On record
Yes
Drug A class
Melatonin Receptor Agonist
Drug B class
Azole Antifungal
Source
FDA drug label - ramelteon

What this means in plain English

( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution. Ketoconazole (strong CYP3A4 inhibitor) The AUC 0-inf and C max of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with ramelteon. Ramelteon should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see Clinical Pharmacology (12.5) ] .

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Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.