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 approved; investigational
ATC Code J04AK06
DrugBank ID DB11637
KEGG ID D09785
MeSH ID C516022
PubChem ID 6480466
TTD Drug ID D0S3NU
NDC Product Code Not Available
UNII 8OOT6M1PC7
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
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)
Photophobia17.17.02.006; 06.01.01.004--
Prurigo23.03.04.017--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash erythematous23.03.13.029--Not Available
Rash maculo-papular23.03.13.004--
Reticulocytosis01.07.02.002--Not Available
Rhinorrhoea22.12.03.021--
Skin disorder23.03.03.007--Not Available
Sleep disorder19.02.04.001--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Supraventricular extrasystoles02.03.03.011--Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus04.04.01.002; 17.04.07.004--
Tremor17.01.06.002--
Urethral disorder20.07.01.002--Not Available
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Ventricular extrasystoles02.03.04.007--Not Available
Vomiting07.01.07.003--
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Oropharyngeal candidiasis22.07.03.003; 11.03.03.006; 07.05.07.003--Not Available
Lymphatic disorder01.09.01.003--Not Available
Eosinophilic pustular folliculitis23.03.03.051; 01.02.04.012--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Transaminases increased13.03.04.036--Not Available
Tinea versicolour23.11.03.013; 11.03.08.006--Not Available
Paraesthesia oral07.05.05.035; 17.02.06.008--Not Available
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