What the FDA labels say about taking them together
Amiodarone and naldemedine
Naldemedine's FDA label of July 25, 2025 names amiodarone in its drug interactions section; the amiodarone labels PlainMeds reads (2) do not name naldemedine. The naldemedine label: “P-glycoprotein (P-gp) Inhibitors Clinical Impact Increase in plasma naldemedine concentrations Intervention Monitor for potential naldemedine-related adverse reactions. …”
Check it at the source: the amiodarone FDA label on DailyMed (effective December 9, 2025, Chartwell RX, LLC); the naldemedine FDA label on DailyMed (effective July 25, 2025, BioDelivery Sciences International Inc).
What does the amiodarone label say about naldemedine?
Amiodarone's label (effective December 9, 2025) and its 1 other brand-application label do not name naldemedine 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 naldemedine label say about amiodarone?
Naldemedine label, drug interactionsP-glycoprotein (P-gp) Inhibitors (e.g., amiodarone, captopril, cyclosporine, quercetin, quinidine, verapamil) 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; …
Source: FDA drug label (SYMPROIC), NDA208854 (Bdsi), as published by BioDelivery Sciences International Inc, effective July 25, 2025 (SPL set b1a1256c-a1eb-4abe-ab1e-30e4711afd16), 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
| Amiodarone | Naldemedine | |
|---|---|---|
| Labeled for | n/a | n/a |
| Boxed warning | Yes | No |
| Pharmacy cost (NADAC) | $0.122 per tablet 200 mg tablet | $16.26 per tablet 0.2 mg tablet |
| Shortage now | No current entry | No 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?
- Check more medicines together
- up to five at once