At a glance
- Methylene blue is an FDA-approved drug, marketed as Provayblue, Methylene (first approval: April 8, 2016).
- PubMed lists 4,592 publications mentioning it, including 281 randomized controlled trials and 346 animal-only studies.
- ClinicalTrials.gov lists 343 registered studies testing it (72 active).
- FDA's adverse event system (FAERS) holds 2,094 reports mentioning it; 1,886 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA204630 | PROVAYBLUE | Approved, marketed | April 8, 2016 | PROVEPHARM SAS |
| ANDA215636 | METHYLENE BLUE | Approved, marketed | December 5, 2023 | ZYDUS LIFESCIENCES |
| ANDA217561 | METHYLENE BLUE | Approved, marketed | November 21, 2024 | NEXUS |
| ANDA216955 | METHYLENE BLUE | Approved, marketed | November 22, 2024 | STERISCIENCE |
| ANDA216959 | METHYLENE BLUE | Approved, marketed | December 17, 2024 | HIKMA |
| ANDA217380 | METHYLENE BLUE | Approved, marketed | January 23, 2025 | MEITHEAL |
| ANDA219363 | METHYLENE BLUE | Approved, marketed | July 30, 2025 | XIROMED |
| ANDA219550 | METHYLENE BLUE | Approved, marketed | December 23, 2025 | CHENGDU SHUODE |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Synthesis, spectroscopic and DFT investigation of a dual-fluorophore methylene blue-naphthalimide probe for selective Cu2+ ions sensing and HeLa cell imaging.
- Pharmacotherapy Management of Calcium Channel Blocker Toxicity in the Emergency Department.
- Bronchoscopic biological sealing of a bronchopleural fistula in post-tuberculous lung disease: a case report.
- Reply: Serratus Anterior Plane Block with Methylene Blue and Ropivacaine for Analgesia in Prosthetic Breast Augmentation: A Randomized Controlled Trial.
- Adjunctive Strategies to Enhance Antimicrobial Photodynamic Therapy in Oral Infections: A Systematic Review of Randomized Controlled Trials.
- Early Administration of Methylene Blue Attenuates Mitochondrial Dysfunction and Cognitive Deficits in a Model of Huntington's Disease.
- Exploring Geiger Count Thresholds for Sentinel Node Identification in Melanoma: Is 10 % Still Optimal?
- Characteristics of Cell Damage at the Division Stage and Nuclear Aberrations in the Buccal Epithelium Cytogram of Individuals with Impaired Carbohydrate Metabolism.
- Robotic-assisted transduodenal ampullectomy for a neuroendocrine tumour: A step-by-step surgical video.
- The Impact of Antimicrobial Photodynamic Therapy (aPDT) with Various Photosensitizers on the Bond Strength of Orthodontic Brackets.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 343
- Active
- 72
- With posted results
- 32
Conditions studied
Show 40 more studies
All 343 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,094
- Serious
- 1,886
- With death outcome
- 273
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) WARNING: SEROTONIN SYNDROME WITH CONCOMITANT USE OF SEROTONERGIC DRUGS AND OPIOIDS Methylene blue may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of methylene blue 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. Methylene blue may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs and opioids. Avoid concomitant use of Methylene blue with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs) and opioids. ( 5.1 , 7.1 ) - GUNA-KIDNEY
- METHYLENE BLUE
- METHYLENE BLUE
- Methylene blue
- Methylene blue
- Methylene Blue
- Methylene Blue
- UROGESIC BLUE
- Methylene blue
- METHYLENE BLUE
- Ozipco 1% METHYLENE BLUE
- Methylene blue
- Methylene Blue
- Uretron D/S
- Methylene blue
- Uro-MP
- Me NaPhos MB Hyo 1
- UROGESIC BLUE
- PROVAYBLUE
- Celltem
- Arthcal 1% METHYLENE BLUE
- Methylene Blue
- Methylene Blue
- URELLE
Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.