Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Delamanid
Drug ID BADD_D00602
Description Delamanid is an anti-tuberculosis agent derived from the nitro-dihydro-imidazooxazole class of compounds that inhibits mycolic acid synthesis of bacterial cell wall [A31965]. It is used in the treatment of multidrug-resistant and extensively drug-resistant tuberculosis (TB) in a combination regimen. Emergence of multidrug-resistant and extensively drug-resistant tuberculosis creates clinical challenges for patients, as the disease is associated with a higher mortality rate and insufficient therapeutic response to standardized antituberculosis treatments as [DB00951] and [DB01045]. Multidrug-resistant tuberculosis may also require more than 2 years of chemotherapy and second-line therapies with narrow therapeutic index [A31968]. In a clinical study involving patients with pulmonary multidrug-resistant tuberculosis or extensively drug-resistant tuberculosis, treatment of delamanid in combination with WHO-recommended optimised background treatment regimen was associated with improved treatment outcomes and reduced mortality rate [A31965]. Spontaneous resistance to delamanid was observed during treatment, where mutation in one of the 5 F420 coenzymes responsible for bioactivation of delamanid contributes to this effect [L1407]. Delamanid is approved by the EMA and is marketed under the trade name Deltyba as oral tablets. It is marketed by Otsuka Pharmaceutical Co., Ltd (Tokyo, Japan).
Indications and Usage Indicated for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability [L1407].
Marketing Status Not Available
ATC Code J04AK06
DrugBank ID DB11637
KEGG ID D09785
MeSH ID C516022
PubChem ID 6480466
TTD Drug ID D0S3NU
NDC Product Code Not Available
Synonyms OPC-67683 | delamanid
Chemical Information
Molecular Formula C25H25F3N4O6
CAS Registry Number 681492-22-8
SMILES CC1(CN2C=C(N=C2O1)[N+](=O)[O-])COC3=CC=C(C=C3)N4CCC(CC4)OC5=CC=C(C=C5)OC(F)(F)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.003--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Dry eye06.08.02.001--
Dry throat22.02.05.004; 07.06.01.005--Not Available
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dysphoria19.04.02.004--Not Available
Dyspnoea22.02.01.004; 02.01.03.002--
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Ear pain04.03.01.003--
Electrocardiogram QT prolonged13.14.05.004--
Electrocardiogram ST segment depression13.14.05.005--Not Available
Eosinophilia01.02.04.001--
Eye disorder06.08.03.001--Not Available
Feeling abnormal08.01.09.014--Not Available
Feeling hot08.01.09.009--Not Available
Flank pain20.02.03.006; 08.01.08.007; 15.03.04.003--
Gamma-glutamyltransferase increased13.03.01.011--
Gastritis07.08.02.001--
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal pain07.01.05.005--
Haematoma24.07.01.001--
Haematuria24.07.01.047; 20.02.01.006--
Haemoptysis24.07.01.006; 22.02.03.004; 02.01.02.006--Not Available
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001--Not Available
Herpes zoster23.09.03.002; 11.05.02.003--
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