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What the FDA labels say about taking them together

Amiodarone and tramadol

Tramadol's FDA label of March 5, 2026 names amiodarone in its warnings and precautions section; the amiodarone labels PlainMeds reads (2) do not name tramadol. The tramadol label: “Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of tramadol hydrochloride oral solution with all cytochrome P450 2D6 inhibitors may result in an increase in tramadol …”

Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the tramadol FDA label on DailyMed (effective March 5, 2026, Lupin Pharmaceuticals, Inc.).

What does the amiodarone label say about tramadol?

Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do not name tramadol 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 tramadol label say about amiodarone?

Tramadol label, warnings and precautions

Risks of Concomitant Use or Discontinuation of Cytochrome P450 2D6 Inhibitors The concomitant use of tramadol hydrochloride extended-release tablets with all cytochrome P450 2D6 inhibitors (e.g., amiodarone, quinidine) may result in an increase in tramadol plasma levels and a decrease in the levels of the active metabolite, M1.

Source: FDA drug label (Tramadol Hydrochloride Extended-Release, NDA022370), Trigen Laboratories, LLC, effective January 23, 2026 (SPL set c0bc7218-3fd0-4646-96f4-25355fc84aa9), via openFDA

Source: FDA drug label (Tramadol Hydrochloride, NDA214044), TruPharma, LLC, effective January 25, 2023 (SPL set aea56ff9-94ac-47a8-8f15-8790d538973b), via openFDA

Source: FDA drug label (TRAMADOL HYDROCHLORIDE), Lupin Pharmaceuticals, Inc., effective March 5, 2026 (SPL set 46bb9ae6-3ee8-463c-badb-c7a45a89b84b), 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
39Tramadol generic labelers
AmiodaroneTramadol
Labeled forn/aPain
Boxed warningYesYes
Pharmacy cost (NADAC)$0.122 per tablet 200 mg tablet$0.0248 per tablet 50 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)

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