Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Methylene blue
Drug ID BADD_D02475
Description Methylene blue is an oxidation-reduction agent. The intravenous form of methylene blue is approved by the FDA for the treatment of pediatric and adult patients with acquired methemoglobinemia. Historically, it has been widely used in Africa to treat malaria, but now it disappeared when chloroquine (CQ) and other drugs entered the market. Its use as an urinary tract antiseptic has also been investigated. Methylthioninium chloride (INN, or methylene blue, proposed trade name Rember) is an investigational drug being developed by the University of Aberdeen and TauRx Therapeutics that has been shown in early clinical trials to be an inhibitor of Tau protein aggregation. The drug is of potential interest for the treatment of patients with Alzheimer's disease.
Indications and Usage Indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. Other clinical applications of methylene blue include improvement of hypotension associated with various clinical states, an antiseptic in urinary tract infections, treatment of hypoxia and hyperdynamic circulation in cirrhosis of liver and severe hepatopulmonary syndrome, and treatment of ifofosamide induced neurotoxicity.
Marketing Status approved; investigational
ATC Code V04CG05; V03AB17
DrugBank ID DB09241
KEGG ID D02312; D10537
MeSH ID D008751
PubChem ID 6099
TTD Drug ID D09NYS
NDC Product Code 54288-147; 73379-101; 0517-0371; 0517-0381; 51927-1115; 0517-0125; 68022-7067; 73379-102; 54288-159; 0517-0374; 17223-0030; 69575-4026; 71052-652
UNII T42P99266K
Synonyms Methylene Blue | Blue, Methylene | Methylthioninium Chloride | Methylthionine Chloride | Swiss Blue | Blue, Swiss | Basic Blue 9 | Blue 9, Basic | Methylene Blue N | Blue N, Methylene | Chromosmon | Urolene Blue | Blue, Urolene
Chemical Information
Molecular Formula C16H18ClN3S
CAS Registry Number 61-73-4
SMILES CN(C)C1=CC2=C(C=C1)N=C3C=CC(=[N+](C)C)C=C3S2.[Cl-]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Agitation17.02.05.012; 19.06.02.0010.000366%
Anaemia01.03.02.0010.000183%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.000183%
Anaphylactic shock10.01.07.002; 24.06.02.0040.000274%-
Blindness06.02.10.003; 17.17.01.0030.000183%-
Chromaturia20.02.01.0020.000274%
Clonus17.02.05.0020.000183%-
Confusional state17.02.03.005; 19.13.01.0010.000366%
Delirium19.13.02.0010.000183%
Depressed level of consciousness17.02.04.0020.000183%
Drug ineffective08.06.01.0060.000805%-
Drug interaction08.06.03.0010.000183%-
Dyskinesia17.01.02.0060.000183%
Encephalopathy17.13.02.0010.001098%
Haemolytic anaemia01.06.03.0020.000274%-
Hyperreflexia17.02.01.0020.000183%-
Hypertension24.08.02.0010.000183%
Hypotension24.06.03.0020.000274%
Injection site erythema08.02.03.001; 12.07.03.001; 23.03.06.0150.000403%-
Injection site necrosis08.02.03.020; 12.07.03.0200.000274%-
Injection site reaction08.02.03.014; 12.07.03.0150.000183%
Leukopenia01.02.02.0010.000183%-
Muscle rigidity15.05.04.001; 17.05.02.0050.000183%-
Mydriasis06.05.03.004; 17.02.11.0030.000274%-
Necrosis08.03.03.001; 24.04.02.0060.000183%-
Nervous system disorder17.02.10.0010.000183%-
Neurotoxicity12.03.01.011; 17.02.10.0020.000183%-
Neutropenia01.02.03.0040.000183%-
Pruritus23.03.12.0010.000403%
Pupillary reflex impaired06.05.03.009; 17.02.11.0070.000183%-
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ADReCS-Target
Drug Name ADR Term Target
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