Buprenorphine and Ketoconazole Interaction

Understanding the Buprenorphine and Ketoconazole Interaction

FDA-approved prescribing information for these two drugs flags their combination as a minor-severity interaction. Buprenorphine belongs to the Partial Opioid Agonist class and Ketoconazole belongs to the Azole Antifungal class - two categories that can collide when co-prescribed. The mechanism described in FDA labeling is: Ketoconazole interferes with the enzymes that break down buprenorphine, which can change the amount of medicine that stays in your blood. Severity tiers matter: major flags generally advise avoidance, moderate flags often require monitoring or dose adjustment, and minor flags may only call for awareness.

Context around a specific patient determines real-world impact. Buprenorphine has 29 total documented interactions on file in this dataset, and Ketoconazole has 113. Each additional medication compounds the interaction surface, which is why pharmacists run full-profile checks rather than evaluating one pair at a time. FDA-derived guidance for this pair is: Your doctor may need to adjust your dose and monitor you for increased side effects or signs of withdrawal. Timing of doses, renal and hepatic function, age, and other concurrent prescriptions all shape whether a labeled interaction matters clinically.

An interaction flag is not a verdict. A large share of labeled interactions are managed routinely in clinical practice, the fix may be as simple as spacing doses or adding a monitoring test. Others require the prescriber to choose a different medication entirely. This page surfaces FDA-sourced labeling and openFDA data for educational purposes only; it is not medical advice and cannot account for your full clinical picture. Never start, stop, or adjust either Buprenorphine or Ketoconazole based on a web page, speak with your prescriber or pharmacist before making any change.