Ramelteon and Ketoconazole Interaction
Drug interaction information between Ramelteon and Ketoconazole.
Ramelteon and Ketoconazole have a documented moderate interaction in FDA labeling.
FDA drug labeling documents a moderate-severity interaction between Ramelteon and Ketoconazole. This page displays the available source-record category and label text. The category is not an individual risk estimate or medication-combination direction.
How They Interact
Ketoconazole blocks the enzyme that breaks down ramelteon, which causes the sleep medicine to build up in your body.
FDA Label Information
( 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) ] .
Ramelteon Also Interacts With
- Fluconazole moderate
- Donepezil minor
- Doxepin minor
- Rifampin minor
- Fluvoxamine minor
Ketoconazole Also Interacts With
- Alfuzosin major
- Dronedarone major
- Ranolazine major
- Saxagliptin major
- Sildenafil major
Frequently Asked Questions
What SPL severity band is on file for Ramelteon + Ketoconazole?
Compiled FDA labeling labels this pair moderate. That is a source-record field, not an individual medication-combination decision.
Which drug in this pair has the larger labeled-interaction portfolio?
Ketoconazole has 113 labeled pairs on file vs Ramelteon's 7. In the moderate band specifically: Ramelteon has 2 (also Fluconazole); Ketoconazole has 22 (also Alprazolam, Aprepitant, Budesonide/Formoterol, Dexamethasone).
What mechanism field is on file for Ramelteon and Ketoconazole?
Ketoconazole blocks the enzyme that breaks down ramelteon, which causes the sleep medicine to build up in your body.
Ketoconazole carries more major-labeled pairs than Ramelteon
SPL source-record counts only. This page's band is moderate · classes on file: Ramelteon (Melatonin Receptor Agonist); Ketoconazole (Azole Antifungal).
Ketoconazole has 6 major-labeled pairs vs Ramelteon's 0. This page itself is in the moderate band, not the major band.
6 major · 22 moderate · 85 minor · 113 total
- Other moderate peers for Ketoconazole
- Alprazolam
- Aprepitant
- Budesonide/Formoterol
- Dexamethasone
Sources: FDA Drug Labels (SPL) via openFDA (2026). This is for informational purposes only and is not medical advice. This registry does not provide individual medication-combination directions.
Read our methodology - how this data is sourced, computed, and verified.