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What the FDA labels say about taking them together

Buprenorphine/naloxone and tramadol

Buprenorphine/naloxone's FDA label of July 26, 2026 names tramadol in its drug interactions section; the tramadol labels PlainMeds reads (3) do not name buprenorphine/naloxone. The buprenorphine/naloxone label: “The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome.”

Check it at the source: the buprenorphine/naloxone FDA label on DailyMed (effective July 26, 2026, Hikma Pharmaceuticals USA Inc.); the tramadol FDA label on DailyMed (effective March 5, 2026, Lupin Pharmaceuticals, Inc.).

What does the buprenorphine/naloxone label say about tramadol?

Buprenorphine/naloxone label, drug interactions

Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and …

Source: FDA drug label (buprenorphine and naloxone), Hikma Pharmaceuticals USA Inc., effective July 26, 2026 (SPL set 713db2c6-0544-4633-b874-cfbeaf93db89), via openFDA; the full label on DailyMed

What does the tramadol label say about buprenorphine/naloxone?

Tramadol's label (effective March 5, 2026) and its 2 other brand-application labels do not name buprenorphine/naloxone in these sections. A label lists what its studies and reports found; it is not a complete list.

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.

These are the ingredient's own label sentences, repeated in a combination product's or a biosimilar's label. The ingredient pair sets them out with both labels side by side.

Both medicines on the record

26Buprenorphine/naloxone generic labelers
39Tramadol generic labelers
Buprenorphine/naloxoneTramadol
Labeled forOpioid use disorderPain
Boxed warningNoYes
Pharmacy cost (NADAC)$0.521 per tablet 2-0.5 mg sl 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)

What next?