Skip to main content

What the FDA labels say about taking them together

Amiodarone and fentanyl

Amiodarone's FDA label of December 9, 2025 names fentanyl in its drug interactions section; the fentanyl labels PlainMeds reads (2) do not name amiodarone. The amiodarone label: “CYP3A Substrate fentanyl Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output.”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the fentanyl FDA label on DailyMed (effective March 6, 2026, Hikma Pharmaceuticals USA Inc.).

What does the amiodarone label say about fentanyl?

Amiodarone label, drug interactions

CYP3A Substrate fentanyl Fentanyl in combination with amiodarone may cause hypotension, bradycardia, and decreased cardiac output.

Source: FDA drug label (Amiodarone Hydrochloride), Chartwell RX, LLC, effective December 9, 2025 (SPL set 5520f11d-968d-4f4f-bf57-d14369c0d746), via openFDA; the full label on DailyMed

What does the fentanyl label say about amiodarone?

Fentanyl's label (effective March 6, 2026) and its 1 other brand-application label do not name amiodarone in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Fentanyl Citrate), Hikma Pharmaceuticals USA Inc., effective March 6, 2026 (SPL set ce5db1c2-feb1-4ad2-847a-d02e865bd47e), 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

32Amiodarone generic labelers
6Fentanyl generic labelers
AmiodaroneFentanyl
Labeled forn/aPain
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$1.79 per mL 100 mcg/2 mL vial
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?