Does Tramadol Hydrochloride Interact with Ketoconazole?
Tramadol Hydrochloride and Ketoconazole have a major drug interaction according to U.S. FDA drug labeling data. ketoconazole), protease inhibitors (e.g., ritonavir) CYP3A4 Inducers Clinical Impact: The concomitant use of tramadol hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of tramadol[see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol.After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase[see Clinical Pharmacology (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures, serotonin syndrome, and/or potentially fatal respiratory depression. 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
- Major
- Ketoconazole Class
- Azole Antifungal
- Management
- Close medical supervision required
- Data Source
- U.S. FDA via OpenFDA
What To Tell Your Doctor or Pharmacist
If you are taking Tramadol Hydrochloride 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 how frequently you should be monitored while these are co-prescribed
- Ask whether any dosage adjustments are needed
- Never stop or change either medication without first consulting your healthcare provider