Methylene Blue: uses, dosing, side effects & brands
Methylene Blue is an oxidation-reduction agent sold in the U.S. under 2 brand and generic names, for cyanosis, herpes simplex and methemoglobinemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Oxidation-Reduction Agent
- Treats (across its forms)
- Cyanosis, Herpes Simplex and Methemoglobinemia
- Available as
- Injectable · Solution
- Sold as
- 2 products — Methylene Blue and Provayblue
- Prescription?
- Prescription only
- Generic available?
- Yes
- Boxed warning
- Boxed warning
How methylene blue is dosed
From the FDA label for Methylene Blue (application ANDA215636). Other methylene blue products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administer 1 mg/kg intravenously over 5-30 minutes. ( 2.1 ) 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. ( 2.1 ) Administer a single dose of 1 mg/kg in patients with moderate or severe renal impairment. ( 2.2 ) 2.1 Dosage and Administration Ensure patent venous access prior to administration of methylene blue injection. Do not administer methylene blue injection subcutaneously. Administer methylene blue injection 1 mg/kg intravenously over 5-30 minutes. If the methemoglobin level remains greater than 30% or if clinical signs and symptoms persist, a repeat dose of methylene blue injection 1 mg/kg may be given one hour after the first dose. If methemoglobinemia does not resolve after 2 doses of methylene blue injection, consider initiating alternative interventions for treatment of methemoglobinemia. 2.2 Recommended Dosage for Renal Impairment The recommended dosage of methylene blue injection in patients with moderate or severe renal impairment (eGFR 15 - 59 mL/min/1.73 m 2 ) is a single dose of 1 mg/kg. If the methemoglobin level remains greater than 30% or if the clinical symptoms persist 1 hour after dosing, consider initiating alternative interventions for the treatment of methemoglobinemia. 2.3 Preparation Methylene blue injection is hypotonic and may be diluted before use in a…
Methylene Blue side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Serotonin Syndrome with Concomitant Use of Serotonergic Drugs [see Warnings and Precautions ( 5.1 )] Anaphylaxis [see Warnings and Precautions ( 5.2 )] Lack of Effectiveness [see Warnings and Precautions ( 5.3 )] Hemolytic Anemia [see Warnings and Precautions ( 5.4 )] Interference with In-Vivo Monitoring Devices [see Warnings and Precautions ( 5.5 )] Effects on Ability to Drive and Operate Machinery [see Warnings and Precautions ( 5.6 )] Interference with Laboratory Tests [see Warnings and Precautions ( 5.7 )] The most commonly reported adverse reactions (≥2%) included headache, hypokalemia, diarrhea, hypomagnesemia, myoclonus, nausea, and seizure-like phenomena. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of methylene blue injection in adults with acquired methemoglobinemia was assessed in 24 patients who received at least 1 dose of methylene blue injection [see…
Who shouldn’t take methylene blue
Methylene blue is contraindicated in the following conditions: Severe hypersensitivity reactions to methylene blue or any other thiazine dye [see Warnings and Precautions ( 5.2 )] . Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia [see Warnings and Precautions ( 5.3 , 5.4 )]. Methylene blue is contraindicated in the following conditions ( 4 ): Severe hypersensitivity to methylene blue Patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
Methylene Blue drug interactions
Clinically significant drug interactions with methylene blue are described below: The concomitant use of methylene blue with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Although the mechanism is not clearly understood, literature reports suggest methylene blue is a potent reversible inhibitor of monoamine oxidase. Avoid concomitant use of methylene blue 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. If the intravenous use of methylene blue cannot be avoided in patients treated with serotonergic medicinal products, choose the lowest possible dose and observe the patient closely for CNS effects for up to 4 hours after administration [see Warning and Precautions ( 5.1 ) and Clinical Pharmacology ( 12.3 )] .
Every methylene blue product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Injectable | No data | — | View → | |
| 2 | Not yet rated | Prescription | Injectable | No data | — | View → |
Methylene Blue recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
What people report to the FDA about methylene blue
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,605 reports naming methylene blue, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- serotonin syndrome518 reports
- hypotension212 reports
- encephalopathy92 reports
- confusional state81 reports
- toxic encephalopathy80 reports
- agitation79 reports
- blood creatine phosphokinase increased76 reports
- acute kidney injury73 reports
Read these as a signal, not a rate. A report does not mean methylene blue caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Related calculators
Frequently asked questions
What is methylene blue?
Methylene Blue is an oxidation-reduction agent used to treat Cyanosis, Herpes Simplex, Methemoglobinemia, Poisoning.
What kind of drug is methylene blue?
The FDA classifies methylene blue as an oxidation-reduction agent. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take methylene blue with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run methylene blue against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is methylene blue sold under?
We track 2 methylene blue-containing products in the U.S.: Methylene Blue and Provayblue. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does methylene blue come in?
Across the brands we track, methylene blue is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic methylene blue?
Yes. Our catalog lists 1 generic methylene blue product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Has methylene blue been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions methylene blue. The most recent: Methylene Blue for Injection (Jul 30, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Methylene Blue: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/methylene-blue
- MLA
- “Methylene Blue: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/methylene-blue.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for methylene blue on DailyMed (NIH) ↗ — including its boxed warning in full.