Prescription and over-the-counter medicine

Methylene blue Brand names: Provayblue

Methylene blue (Provayblue) is a prescription and over-the-counter medicine with an FDA approval on record since 2016. FDA's NDC Directory lists it from 11 generic labelers.

Generic listed
Boxed warning

Check it at the source: the methylene blue FDA label on DailyMed (effective May 28, 2025, American Regent, Inc.); the NDA 204630 record on Drugs@FDA; every methylene blue label on DailyMed.

Highlights of the record

FDA label of May 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS.

PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. [see Warnings and Precautions ( 5.1 ) and Drug Interactions ( 7.1 )]. WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS See full prescribing information for complete boxed warning. PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids.

Used for

From the label: indications and usage
PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

Forms and strengths

5 mg/ml
10 mg/ml
50 mg/10ml

Injection; injection (solution).

On the market

Earliest approval on file: April 8, 2016 Provayblue, Provepharm Sas; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 7 first December 5, 2023; 7 with a marketed status in Drugs@FDA
Labelers listed (NDC): 12 of which 11 under generic applications, 1 under brand applications, repackagers included; 2 more under the over-the-counter monograph, without an application

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2017 0 Class I among all firms' recalls; latest July 30, 2025; 2 more by firms not listed as its makers
FAERS reports: 1,550 through July 30, 2026

What is methylene blue used for?

From the label: indications and usage
PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. PROVAYBLUE (methylene blue) is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

FDA pharmacologic class: Oxidation-Reduction Agent.

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

Is there a generic for methylene blue (Provayblue)?

The FDA approved the first generic methylene blue on December 5, 2023. 7 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists methylene blue from 11 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

2016 earliest approval on file
2023 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has methylene blue been recalled?

The FDA's Enforcement Report lists 3 recalls naming methylene blue since 2017: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of methylene blue and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
July 30, 2025	Class II	GenoGenix LLC	Lack of Assurance of Sterility
May 17, 2018	Class II	Guardian Pharmacy Services not a listed maker	Lack of sterility assurance.
November 16, 2017	Class II	KRS Global Biotechnology, Inc not a listed maker	Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the methylene blue label say about other medicines?

The methylene blue label names 7 other medicines in its interaction, contraindication or warning sections. The labels of 30 other medicines name methylene blue. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Bupropion	drug interactions	… inhibitors), SNRIs (serotonin and norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Buspirone	drug interactions	… SNRIs (serotonin and norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Clomipramine	drug interactions	… (serotonin and norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Dapsone	warnings and precautions	Methemoglobinemia may not resolve or may rebound after response to treatment with PROVAYBLUE in patients with methemoglobinemia due to aryl amines such as aniline or sulfa drugs such as dapsone.
Dextromethorphan	drug interactions	… MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Linezolid	drug interactions	… reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.
Mirtazapine	drug interactions	… norepinephrine reuptake inhibitors), MAOIs (monoamine oxidase inhibitors), bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, and dextromethorphan because of the potential for serious CNS reactions, including potentially fatal serotonin syndrome.

Other labels that name methylene blue

Check methylene blue against other medicines

What do FAERS reports show for methylene blue?

The FDA Adverse Event Reporting System holds 1,550 reports that list methylene blue among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 939 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Serotonin Syndrome (named in the label)469
Drug Interaction (a use or a product term, not a reaction)358
Drug Ineffective (a use or a product term, not a reaction)303
Hypotension207
Off Label Use (a use or a product term, not a reaction)182
Toxicity To Various Agents140
Overdose (a use or a product term, not a reaction)106
Intentional Overdose (a use or a product term, not a reaction)100

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Methylene blue side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other