{"shortAnswer":"Methylene blue is FDA-approved as a drip into a vein for a rare blood disorder. No approval covers memory or mood, where the evidence grade is limited-human: a few small trials. It can cause a deadly reaction with some antidepressants.","url":"https://peptideindex.ai/compound/methylene-blue","status":"fda-approved","statusCheckedAt":"2026-10-26T13:39:14.633Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T17:05:08.853Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204630","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"9cc943d0-1d50-420d-a2d6-dfa4bae0a6a4","object":"compound","slug":"methylene-blue","name":"Methylene blue","attrs":{"name":"Methylene blue","class":"non-peptide","access":[{"type":"approved-product","detail":"Approved by FDA as a prescription drug given by drip into a vein.","indication":"Acquired methemoglobinemia in children and adults.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","brand_names":["ProvayBlue"],"manufacturer":"Provepharm SAS"},{"type":"lawful-compounding","detail":"Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug. A compounded product is not FDA-approved.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"}],"dosing":"From the ProvayBlue label. It is given by drip into a vein over 5 to 30 minutes, at 1 mg per kilogram of body weight. If the blood level stays above 30% or symptoms persist, one more dose of up to 1 mg per kilogram may be given an hour later. People with moderate or severe kidney disease get a single dose. The prescriber sets the dose.","trials":[],"aliases":["methylthionium chloride"],"summary":"A blue dye that is a prescription drug for a rare blood disorder. Drops of it are also promoted online for brain health.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204630","tier":"primary","type":"regulatory","title":"Drugs@FDA: ProvayBlue (methylene blue) injection, application 204630"},{"n":2,"url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","tier":"primary","type":"label","title":"DailyMed: ProvayBlue (methylene blue) injection label, revised February 2024"},{"n":3,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":4,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list, updated May 2026"},{"n":5,"url":"https://www.fda.gov/media/98973/download","tier":"primary","type":"regulatory","title":"FDA guidance: compounded drugs that are essentially copies, January 2018"},{"n":6,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-wellness-and-integrative-medicine-608693-06302020","tier":"primary","type":"regulatory","title":"FDA warning letter: methylene blue capsules sold with COVID-19 claims, 30 June 2020"},{"n":7,"url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020","tier":"primary","type":"regulatory","title":"FDA warning letter: methylene blue products sold with COVID-19 claims, 19 June 2020"},{"n":8,"url":"https://pubmed.ncbi.nlm.nih.gov/27351678/","tier":"peer-reviewed","type":"rct","title":"Randomized trial: methylene blue and brain scans of memory in healthy adults, 2016"},{"n":9,"url":"https://pubmed.ncbi.nlm.nih.gov/27284082/","tier":"peer-reviewed","type":"rct","title":"Randomized crossover trial: methylene blue in bipolar disorder, 2017"},{"n":10,"url":"https://pubmed.ncbi.nlm.nih.gov/17721552/","tier":"peer-reviewed","type":"in-vitro","title":"Enzyme study: methylene blue, MAO A and serotonin toxicity, 2007"},{"n":11,"url":"https://pubmed.ncbi.nlm.nih.gov/38904978/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review and meta-analysis: methylene blue in septic shock, 2024"},{"n":12,"url":"https://pubmed.ncbi.nlm.nih.gov/40879922/","tier":"peer-reviewed","type":"animal","title":"Mouse study: methylene blue and spatial memory after brain injury, 2025"},{"n":13,"url":"https://pubmed.ncbi.nlm.nih.gov/38606972/","tier":"peer-reviewed","type":"reference","title":"Hematology report: methylene blue and G6PD deficiency, 2024"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/34463662/","tier":"peer-reviewed","type":"reference","title":"Review: methylene blue as an antidote for methemoglobinemia, 2021"},{"n":15,"url":"https://clinicaltrials.gov/study/NCT02380573","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT02380573: methylene blue in healthy aging, mild cognitive impairment and Alzheimer's disease"},{"n":16,"url":"https://clinicaltrials.gov/study/NCT01836094","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT01836094: USP methylene blue, memory and brain scans"},{"n":17,"url":"https://www.npr.org/2025/12/15/nx-s1-5634680/methylene-blue-supplement-safety","tier":"established-news","type":"reference","title":"NPR: methylene blue wellness claims and the research, December 2025"}],"known_risks":["The label carries a boxed warning. Methylene blue can cause serotonin syndrome, which can kill, when used with some antidepressants or with opioids [^2].","Methylene blue strongly blocks MAO A, an enzyme. An enzyme study says this may be why it can cause serotonin toxicity in people who take some antidepressants [^10].","People with G6PD deficiency, an inherited red blood cell problem, can have their red blood cells break down. The label says they must not get it [^2] [^13] [^17].","Some people have had serious allergic reactions [^2].","It may harm an unborn baby, the label says [^2].","It can cause confusion, dizziness and trouble seeing. The label advises against driving until these pass [^2].","In the label's study, the most common problems were headache, diarrhea, nausea and muscle jerks. Low potassium, low magnesium and seizure-like events were on the list too [^2].","It can make a finger oxygen monitor read too low. It also turns urine blue [^2] [^17]."],"short_answer":"Methylene blue is FDA-approved as a drip into a vein for a rare blood disorder. No approval covers memory or mood, where the evidence grade is limited-human: a few small trials. It can cause a deadly reaction with some antidepressants.","evidence_grade":"limited-human","open_questions":["Nobody knows if methylene blue by mouth helps memory over time. The 2016 brain scan trial tested one dose in 26 healthy adults [^8].","The bipolar trial found less depression and anxiety in 37 people who also took another drug [^9]. Nobody knows if it helps others with depression.","In septic shock, the 2024 review rated its evidence as low certainty and called for better trials [^11].","Experts quoted by NPR in 2025 called the human findings for brain health early [^17].","Buyers online may not know what is in the bottle. An expert quoted by NPR said oversight of supplements is weak [^17].","A mouse study after brain injury does not show that it helps healthy people think better [^12]."],"section_routes":"The legal way to get methylene blue is ProvayBlue, a prescription drug given by drip into a vein [^1] [^2]. It is approved for acquired methemoglobinemia in children and adults [^2].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^3]. A compounded product is not FDA-approved [^5].\n\nTwo US trials of methylene blue for memory have finished [^15] [^16]. The trials block on this page lists open trials with their dates.","regulatory_as_of":"2026-10-26","section_channels":"Drops of methylene blue are promoted online for brain health and long life [^17]. Many of these products are not labeled as dietary supplements [^17].\n\nIn June 2020, FDA and the Federal Trade Commission sent warning letters to two wellness centers [^6] [^7]. Each sold methylene blue products online with claims about COVID-19. FDA called the products unapproved new drugs and misbranded drugs [^6] [^7]. FDA told consumers not to buy or use such products [^6].","section_evidence":"The evidence grade is limited-human: for memory and mood, there are only a few small trials in people [^8] [^9]. In a 2016 trial, 26 healthy adults took one low dose by mouth or a dummy pill [^8]. An hour later, brain scans showed more activity during memory tasks [^8]. Correct answers on one memory test rose by 7% [^8].\n\nIn a 2017 trial, 37 people with bipolar disorder took it beside their usual drug [^9]. It eased leftover depression and anxiety. It did not help thinking skills [^9].\n\nFor its approved use, the label reports 31 adults with acquired methemoglobinemia [^2]. In 26 of 28 people with a level measured before treatment, the level fell by half or more [^2]. In septic shock, a 2024 review of six trials with 302 patients found it may lower early deaths [^11]. The review rated that evidence as low certainty [^11].\n\nMuch of the brain story comes from animals. In mice with a brain injury, it partly kept memory from getting worse [^12]. That does not show it helps healthy people.","regulatory_status":"fda-approved","section_what_it_is":"Methylene blue is a blue dye that is also a medicine. It has been used in medicine for centuries [^14]. It is not a peptide.\n\nThe approved drug is ProvayBlue, a liquid given by drip into a vein [^1] [^2]. It treats acquired methemoglobinemia, a rare blood disorder [^2] [^17]. The dye also strongly blocks MAO A, an enzyme that acts on serotonin [^10].\n\nOnline, drops of it are promoted for brain health and long life [^17]. Its color can stain the tongue and urine blue [^17].","section_is_it_legal":"Methylene blue is FDA-approved: Drugs@FDA lists ProvayBlue, a prescription drug given by drip into a vein, as an approved drug [^1]. That approval covers one use, acquired methemoglobinemia in children and adults [^2]. It does not cover pills or drops taken by mouth for memory, mood or energy. Checked 26 October 2026.\n\nIn June 2020, FDA sent warning letters about methylene blue products sold online with COVID-19 claims [^6] [^7]. FDA called them unapproved new drugs and misbranded drugs [^6] [^7]. A news report says it is not clear that methylene blue can be sold as a dietary supplement [^17].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^3]. Methylene blue is the active part of ProvayBlue [^1]. It is not on FDA's 503A category list [^4]. Compounded drugs are not FDA-approved, and FDA has not reviewed them before sale [^5]. A pharmacy may not regularly make copies of a drug that is on the market [^5].","unofficial_channels":[{"type":"clinic-or-med-spa","what_it_is":"Wellness centers that sold methylene blue capsules and other methylene blue products on their websites with claims about COVID-19.","enforcement":[{"date":"2020-06-19","text":"FDA and Federal Trade Commission warning letter to a wellness center that sold methylene blue products online with COVID-19 claims.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020"},{"date":"2020-06-30","text":"FDA and Federal Trade Commission warning letter to a wellness center that sold methylene blue capsules online with COVID-19 claims.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-wellness-and-integrative-medicine-608693-06302020"}],"legal_position":{"text":"FDA called these products unapproved new drugs and misbranded drugs. Shipping them across state lines is prohibited under federal law.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020"},"documented_risks":[{"text":"The products were sold to prevent or treat COVID-19. FDA and the Federal Trade Commission said no study was known to show that they could.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020"},{"text":"FDA advised consumers not to buy or use products it had not approved that were sold with COVID-19 claims.","source_url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-wellness-and-integrative-medicine-608693-06302020"}]}]},"provenance":{"name":{"fact_id":"be946375-1c8c-4f5d-9bf6-7c4e97a5726f","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","source_type":"primary","captured_at":"2026-10-26T10:01:26.553Z","checked_at":"2026-10-26T17:05:08.825Z","confidence":1,"stale":false},"class":{"fact_id":"9fef1bc5-29f9-4620-9a90-c30a75f08318","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","source_type":"primary","captured_at":"2026-10-26T10:01:26.553Z","checked_at":"2026-10-26T17:05:08.830Z","confidence":1,"stale":false},"access":{"fact_id":"940447de-3d0b-4fc0-80e0-d6b50e5d910a","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204630","source_type":"primary","captured_at":"2026-10-26T10:01:28.938Z","checked_at":"2026-10-26T13:39:14.607Z","confidence":1,"stale":false},"dosing":{"fact_id":"d772b0c7-204d-410e-a40b-260688eebc2f","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","source_type":"primary","captured_at":"2026-10-26T10:01:26.553Z","checked_at":"2026-10-26T17:05:08.845Z","confidence":1,"stale":false},"trials":{"fact_id":"5fceb92a-d770-48d7-9473-2482a2127d82","source_url":"https://clinicaltrials.gov/api/v2/studies?query.intr=USP+methylene+blue&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","source_type":"primary","captured_at":"2026-10-26T17:05:16.187Z","checked_at":"2026-10-26T17:05:16.187Z","confidence":1,"stale":false},"aliases":{"fact_id":"93f0999a-9ef7-4d11-9713-b9b86f602bb3","source_url":"https://pubmed.ncbi.nlm.nih.gov/17721552/","source_type":"peer-reviewed","captured_at":"2026-10-26T10:03:20.784Z","checked_at":"2026-10-26T17:05:08.827Z","confidence":1,"stale":false},"summary":{"fact_id":"6e74aae5-458e-4c1b-8e85-0b12a0770c74","source_url":"https://www.npr.org/2025/12/15/nx-s1-5634680/methylene-blue-supplement-safety","source_type":"established-news","captured_at":"2026-10-26T10:03:20.029Z","checked_at":"2026-10-26T17:05:08.817Z","confidence":1,"stale":false},"citations":{"fact_id":"1e1c8685-4c58-4413-8e46-c7e11211503c","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","source_type":"primary","captured_at":"2026-10-26T10:01:26.553Z","checked_at":"2026-10-26T17:05:08.853Z","confidence":1,"stale":false},"known_risks":{"fact_id":"4f0ed138-95fa-4795-ad6a-a35ce13a7d62","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","source_type":"primary","captured_at":"2026-10-26T10:01:26.553Z","checked_at":"2026-10-26T13:39:14.621Z","confidence":1,"stale":false},"short_answer":{"fact_id":"dca3b1ab-32e4-40e7-8c7d-79c2058f1492","source_url":"https://peptideindex.ai/methodology#short-answer","source_type":"reference","captured_at":"2026-10-25T00:14:44.418Z","checked_at":"2026-10-26T17:05:08.821Z","confidence":1,"stale":false,"label":"our 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septic shock, 2024","url":"https://pubmed.ncbi.nlm.nih.gov/38904978/"},{"n":12,"title":"Mouse study: methylene blue and spatial memory after brain injury, 2025","url":"https://pubmed.ncbi.nlm.nih.gov/40879922/"}],"section_what_it_is":[{"n":14,"title":"Review: methylene blue as an antidote for methemoglobinemia, 2021","url":"https://pubmed.ncbi.nlm.nih.gov/34463662/"},{"n":1,"title":"Drugs@FDA: ProvayBlue (methylene blue) injection, application 204630","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204630"},{"n":2,"title":"DailyMed: ProvayBlue (methylene blue) injection label, revised February 2024","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232"},{"n":17,"title":"NPR: methylene blue wellness claims and the research, December 2025","url":"https://www.npr.org/2025/12/15/nx-s1-5634680/methylene-blue-supplement-safety"},{"n":10,"title":"Enzyme study: methylene blue, MAO A and serotonin toxicity, 2007","url":"https://pubmed.ncbi.nlm.nih.gov/17721552/"}],"section_is_it_legal":[{"n":1,"title":"Drugs@FDA: ProvayBlue (methylene blue) injection, application 204630","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204630"},{"n":2,"title":"DailyMed: ProvayBlue (methylene blue) injection label, revised February 2024","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232"},{"n":6,"title":"FDA warning letter: methylene blue capsules sold with COVID-19 claims, 30 June 2020","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/center-wellness-and-integrative-medicine-608693-06302020"},{"n":7,"title":"FDA warning letter: methylene blue products sold with COVID-19 claims, 19 June 2020","url":"https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020"},{"n":17,"title":"NPR: methylene blue wellness claims and the research, December 2025","url":"https://www.npr.org/2025/12/15/nx-s1-5634680/methylene-blue-supplement-safety"},{"n":3,"title":"FDA: bulk drug substances used in compounding under section 503A","url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"},{"n":4,"title":"FDA: 503A bulk drug substances category list, updated May 2026","url":"https://www.fda.gov/media/94155/download"},{"n":5,"title":"FDA guidance: compounded drugs that are essentially copies, January 2018","url":"https://www.fda.gov/media/98973/download"}]},"channelsOpener":"This section describes what happens and is not a recommendation.","sources":["https://clinicaltrials.gov/api/v2/studies?query.intr=USP+methylene+blue&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState","https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4f6848e5-35ed-4046-b13c-3032b5ba3232","https://peptideindex.ai/methodology#evidence-grade","https://peptideindex.ai/methodology#short-answer","https://pubmed.ncbi.nlm.nih.gov/17721552/","https://pubmed.ncbi.nlm.nih.gov/27351678/","https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204630","https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/north-isle-wellness-center-607947-06192020","https://www.npr.org/2025/12/15/nx-s1-5634680/methylene-blue-supplement-safety"],"verified_at":"2026-10-26T17:05:08.853Z","published_at":"2026-10-26T17:05:15.404Z","parent":null,"children":[],"snapshots":{"trials":{"snapshot_at":"2026-10-26T17:05:16.187Z","stale":false,"notice":"A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}