Does Vardenafil Hydrochloride Interact with Ketoconazole?
Vardenafil Hydrochloride and Ketoconazole have a major drug interaction according to U.S. FDA drug labeling data. Strong CYP3A4 inhibitor producing a 10-fold increase in vardenafil AUC and 4-fold increase in Cmax, significantly increasing vardenafil exposure and risk of adverse effects. The mechanism involves inhibition of cyp3a4/5-mediated metabolism. 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
- Vardenafil Hydrochloride Class
- Phosphodiesterase 5 Inhibitor
- Ketoconazole Class
- Azole Antifungal
- Management
- Close medical supervision required
- Data Source
- U.S. FDA via OpenFDA
How This Interaction Works
The interaction between Vardenafil Hydrochloride and Ketoconazole occurs because inhibition of cyp3a4/5-mediated metabolism. Clinically, this means strong cyp3a4 inhibitor producing a 10-fold increase in vardenafil auc and 4-fold increase in cmax, significantly increasing vardenafil exposure and risk of adverse effects. This is classified as a major interaction, meaning it could cause serious harm if not properly managed. Your healthcare provider may need to adjust dosages, substitute one medication, or increase monitoring frequency.
What To Tell Your Doctor or Pharmacist
If you are taking Vardenafil 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