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What the FDA labels say about taking them together

Mirtazapine and tapentadol

Tapentadol's FDA label of February 26, 2026 names mirtazapine in its drug interactions section; the mirtazapine label PlainMeds reads does not name tapentadol. The tapentadol 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 mirtazapine FDA label on DailyMed (effective August 6, 2025, Organon LLC); the tapentadol FDA label on DailyMed (effective February 26, 2026, Hikma Pharmaceuticals USA Inc.).

What does the mirtazapine label say about tapentadol?

Mirtazapine's label (effective August 6, 2025) does not name tapentadol in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (REMERON), Organon LLC, effective August 6, 2025 (SPL set 98ad1917-a094-44f5-a28f-a64a8cfcd887), via openFDA; the full label on DailyMed

What does the tapentadol label say about mirtazapine?

Tapentadol label, drug interactions

Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. … (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as …

Tapentadol label, warnings and precautions

Serotonergic drugs include selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonergic neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and drugs that impair metabolism of serotonin (including monoamine oxidase inhibitors, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) [see Drug Interactions (7) ].

Source: FDA drug label (TAPENTADOL), Hikma Pharmaceuticals USA Inc., effective February 26, 2026 (SPL set 863f3fd3-1e8d-41b0-855f-8f9a29237cda), 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

36Mirtazapine generic labelers
4Tapentadol generic labelers
MirtazapineTapentadol
Labeled forDepressionPain
Boxed warningYesYes
Pharmacy cost (NADAC)$0.063 per tablet 15 mg tablet$14.48 per tablet 100 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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