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What the FDA labels say about taking them together

Methylene blue and vortioxetine

Vortioxetine's FDA label of March 5, 2025 names methylene blue in its contraindications section; the methylene blue label PlainMeds reads does not name vortioxetine. The vortioxetine label: “Starting TRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.”

Check it at the source: the methylene blue FDA label on DailyMed (effective May 28, 2025, American Regent, Inc.); the vortioxetine FDA label on DailyMed (effective March 5, 2025, Takeda Pharmaceuticals America, Inc.).

What does the methylene blue label say about vortioxetine?

Methylene blue's label (effective May 28, 2025) does not name vortioxetine in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (PROVAYBLUE), NDA204630 (Provepharm Sas), as published by American Regent, Inc., effective May 28, 2025 (SPL set 4f6848e5-35ed-4046-b13c-3032b5ba3232), via openFDA; the full label on DailyMed

What does the vortioxetine label say about methylene blue?

Vortioxetine label, contraindications

Starting TRINTELLIX in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2) ].

Vortioxetine label, drug interactions

In a patient who is being treated with linezolid or intravenous methylene blue. [see Dosage and Administration (2.4), Contraindications (4), Warnings and Precautions (5.2) ] Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of TRINTELLIX with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when TRINTELLIX is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. …

Vortioxetine label, warnings and precautions

If it is necessary to initiate treatment with an MAOI such as linezolid or intravenous methylene blue in a patient taking TRINTELLIX, discontinue TRINTELLIX before initiating treatment with the MAOI [see Contraindications (4), Drug Interactions (7.1) ].

Source: FDA drug label (Trintellix), Takeda Pharmaceuticals America, Inc., effective March 5, 2025 (SPL set 1a5b68e2-14d0-419d-9ec6-1ca97145e838), 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

11Methylene blue generic labelers
0Vortioxetine generic labelers
Methylene blueVortioxetine
Labeled forn/aDepression
Boxed warningYesYes
Pharmacy cost (NADAC)n/a$17.20 per tablet 10 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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