Skip to main content

What the FDA labels say about taking them together

Ketoconazole and sufentanil

Sufentanil's FDA label of June 1, 2026 names ketoconazole in its drug interactions section; the ketoconazole label PlainMeds reads does not name sufentanil. The sufentanil label: “… macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of sufentanil and prolong opioid adverse reactions …”

Check it at the source: the ketoconazole FDA label on DailyMed (effective January 28, 2026, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC); the sufentanil FDA label on DailyMed (effective June 1, 2026, Hospira, Inc.).

What does the ketoconazole label say about sufentanil?

Ketoconazole's label (effective January 28, 2026) does not name sufentanil in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (ketoconazole), E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026 (SPL set cad7c647-34a9-4e4e-83b3-8d78e58f588f), via openFDA; the full label on DailyMed

What does the sufentanil label say about ketoconazole?

Sufentanil label, drug interactions

Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir), grapefruit juice.

Sufentanil label, warnings and precautions

Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers Concomitant use of Sufentanil Citrate Injection with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of sufentanil and prolong opioid adverse reactions, which may exacerbate fatal respiratory depression [see Warnings and Precautions (5.2) ], particularly when an inhibitor is added after a stable dose of Sufentanil Citrate Injection is achieved.

Source: FDA drug label (Sufentanil Citrate), Hospira, Inc., effective June 1, 2026 (SPL set 20293943-46ff-4345-1aa4-929b4e017a25), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

30Ketoconazole generic labelers
1Sufentanil generic labelers
KetoconazoleSufentanil
Labeled forFungal infectionsn/a
Boxed warningNoYes
Pharmacy cost (NADAC)$0.249 per gram 2% creamn/a
Shortage nowNo current entryIn shortage

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?