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What the FDA labels say about taking them together

Codeine and mirtazapine

Codeine's FDA label of December 22, 2025 names mirtazapine in its drug interactions section; the mirtazapine label PlainMeds reads does not name codeine. The codeine 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 codeine FDA label on DailyMed (effective December 22, 2025, Hikma Pharmaceuticals USA Inc.); the mirtazapine FDA label on DailyMed (effective August 6, 2025, Organon LLC).

What does the codeine label say about mirtazapine?

Codeine 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 effect 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 …

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

What does the mirtazapine label say about codeine?

Mirtazapine's label (effective August 6, 2025) does 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 (REMERON), Organon LLC, effective August 6, 2025 (SPL set 98ad1917-a094-44f5-a28f-a64a8cfcd887), 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

1Codeine generic labelers
36Mirtazapine generic labelers
CodeineMirtazapine
Labeled forPainDepression
Boxed warningYesYes
Pharmacy cost (NADAC)$0.726 per tablet 30 mg tablet$0.063 per tablet 15 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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