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Does Naldemedine Interact with Fluconazole?

Naldemedine and Fluconazole have a major drug interaction according to U.S. FDA drug labeling data. Moderate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A Inhibitors Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ] . Strong CYP3A inducers (e.g., rifampin) : Decreased naldemedine concentrations; avoid concomitant use ( 7 ) Other opioid antagonists : Potential for additive effect and increased risk of opioid withdrawal; avoid concomitant use ( 7 ) Moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A4 inhibitors : Increased naldemedine concentrations; monitor for adverse reactions ( 7 ) P-gp inhibitors (e.g., cyclosporine) : Monitor for adverse reactions ( 7 ) 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
Fluconazole 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 Naldemedine and your doctor is considering prescribing Fluconazole (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
💊 Naldemedine(Symproic)+💊 Fluconazole

Severity & Interaction Details

⚠️
major
Use with caution — major interaction
Serious risk of clinically significant harm. Generally avoid; if used, monitor closely.
Severity scale
MinorContra
On record
Yes
Drug A class
—
Drug B class
Azole Antifungal
Source
FDA drug label - naldemedine

What this means in plain English

Moderate (e.g., fluconazole, atazanavir, aprepitant, diltiazem, erythromycin) and Strong (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, saquinavir) CYP3A Inhibitors Clinical Impact Increase in plasma naldemedine concentrations [see Clinical Pharmacology (12.3) ] Intervention Monitor for potential naldemedine-related adverse reactions [see Adverse Reactions (6.1) ] . Strong CYP3A inducers (e.g., rifampin) : Decreased naldemedine concentrations; avoid concomitant use ( 7 ) Other opioid antagonists : Potential for additive effect and increased risk of opioid withdrawal; avoid concomitant use ( 7 ) Moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A4 inhibitors : Increased naldemedine concentrations; monitor for adverse reactions ( 7 ) P-gp inhibitors (e.g., cyclosporine) : Monitor for adverse reactions ( 7 )

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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.