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What the FDA labels say about taking them together

Amiodarone and codeine

Codeine's FDA label of December 22, 2025 names amiodarone in its warnings and precautions section; the amiodarone labels PlainMeds reads (2) do not name codeine. The codeine label: “Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors: The concomitant use of Codeine Sulfate Tablets with all cytochrome P450 2D6 inhibitors may result in an increase in codeine plasma …”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the codeine FDA label on DailyMed (effective December 22, 2025, Hikma Pharmaceuticals USA Inc.).

What does the amiodarone label say about codeine?

Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do not name codeine in these sections. A label lists what its studies and reports found; it is not a complete list.

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 codeine label say about amiodarone?

Codeine label, warnings and precautions

Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors: The concomitant use of Codeine Sulfate Tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in codeine plasma concentrations and a decrease in active metabolite morphine plasma concentration which could result in an analgesic efficacy reduction or symptoms of opioid withdrawal.

Source: FDA drug label (Codeine sulfate), Hikma Pharmaceuticals USA Inc., effective December 22, 2025 (SPL set 010905f9-3bcb-4b50-9fe8-a3ad0010f14c), 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
1Codeine generic labelers
AmiodaroneCodeine
Labeled forn/aPain
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$0.726 per tablet 30 mg tablet
Shortage nowNo current entryNo current entry

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

What next?