Molecule
Methylene blue is an oxidation-reduction agent indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. It is available as injection for intravenous use. MedsAcross supplies Methylene blue for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Methylene blue is a water soluble thiazine dye that promotes a non-enyzmatic redox conversion of metHb to hemoglobin. In situ, methylene blue is first converted to leucomethylene blue (LMB) via NADPH reductase. It is the LMB molecule which then reduces the ferric iron of metHb to the ferrous state of normal hemoglobin.
Source: US FDA prescribing information
Administer 1 mg/kg intravenously over 5-30 minutes. If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose. Administer a single dose of 1 mg/kg in patients with moderate or severe renal impairment.
Source: US FDA prescribing information
PROVAYBLUE is contraindicated in the following conditions: Severe hypersensitivity reactions to methylene blue or any other thiazine dye. Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia. PROVAYBLUE is contraindicated in the following conditions: Severe hypersensitivity to methylene blue Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
Source: US FDA prescribing information
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. Hypersensitivity: If severe or life threatening allergic reaction occurs, discontinue PROVAYBLUE, treat the allergic reaction, and monitor until signs and symptoms resolve. Lack of Effectiveness: Consider alternative treatments if there is no resolution of methemoglobinemia after 2 doses. Hemolytic Anemia: Discontinue PROVAYBLUE and transfuse. Interference with In-Vivo Monitoring Devices: Use methods other than pulse oximetry to assess oxygen saturation.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: Serotonin Syndrome with Concomitant Use of Serotonergic Drugs Anaphylaxis Lack of Effectiveness Hemolytic Anemia Interference with In-Vivo Monitoring Devices Effects on Ability to Drive and Operate Machinery Interference with Laboratory Tests The most commonly reported adverse reactions (>2%) included headache, hypokalemia, diarrhea, hypomagnesemia, myoclonus, nausea, and seizure-like phenomena.
Source: US FDA prescribing information
Clinically significant drug interactions with PROVAYBLUE are described below: The concomitant use of PROVAYBLUE with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Although the mechanism is not clearly understood, literature reports suggest PROVAYBLUE is a potent reversible inhibitor of monoamine oxidase. Avoid concomitant use of PROVAYBLUE with medicinal products that enhance serotonergic transmission including antidepressants like SSRIs (selective serotonin reuptake 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.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not refrigerate or freeze. Keep the ampule or the vial in the original package to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Methylene blue, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Methylene blue 50 mg/10 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Methylene blue 100 mg/10 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Methylene blue 10 mg/2 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Provayblue 10 mg/2 mL injectionIntravenous | American Regent | US FDA | Available on request |
| Provayblue 50 mg/10 mL injectionIntravenous | American Regent | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 5 presentations of Methylene blue and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Methylene blue, including Provayblue.
Yes. The US FDA first approved Methylene blue on 8 April 2016, according to Drugs@FDA.
Yes. Methylene blue has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Methylene blue is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Methylene blue is classified under ATC code V03AB17 (Methylene blue).
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