Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clofazimine
Drug ID BADD_D00496
Description Clofazimine is a highly lipophilic antimicrobial riminophenazine dye used in combination with other agents, such as [dapsone], for the treatment of leprosy. It was originally described in 1957 and was the prototypical riminophenazine dye - a bright-red dye that, in its clinical use, results in long-lasting discoloration of the skin and bodily fluids.[A203144] Although it carries _in vitro_ activity against other mycobacterium, such as _Mycobacterium tuberculosis_, it is generally considered an ineffective treatment in comparison to classic tuberculosis treatments such as [rifampicin] and [isoniazid].[A203144]
Indications and Usage Clofazimine is indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum.[L13802] To prevent the development of drug resistance, it should be used only in combination with other antimycobacterial leprosy treatments.
Marketing Status approved; investigational
ATC Code J04BA01
DrugBank ID DB00845
KEGG ID D00278
MeSH ID D002991
PubChem ID 2794
TTD Drug ID D0S5UH
NDC Product Code 59349-0030; 46016-2030
UNII D959AE5USF
Synonyms Clofazimine | N,5-Bis(4-chlorophenyl)-3,5-dihydro-3-((1-methylethyl)imino)-2-phenazinamine | Lamprene | B-663 | B 663 | B663 | G-30,320 | G 30,320 | G30,320
Chemical Information
Molecular Formula C27H22Cl2N4
CAS Registry Number 2030-63-9
SMILES CC(C)N=C1C=C2C(=NC3=CC=CC=C3N2C4=CC=C(C=C4)Cl)C=C1NC5=CC=C(C=C5)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)
Abdominal pain upper07.01.05.003--
Anaemia01.03.02.001--
Asthenia08.01.01.001--Not Available
Bladder pain20.02.02.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.001--
Cheilosis23.03.03.026; 07.05.01.002--Not Available
Completed suicide19.12.01.001; 08.04.01.010--Not Available
Constipation07.02.02.001--
Corneal pigmentation06.06.03.013--Not Available
Cystitis20.03.02.002; 11.01.14.001--
Depression19.15.01.001--
Dermatitis23.03.04.002--Not Available
Dermatitis acneiform23.02.01.004--
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dysgeusia07.14.03.001; 17.02.07.003--
Embolism venous24.01.01.003--Not Available
Enteritis07.08.03.002--
Eosinophilia01.02.04.001--
Fatigue08.01.01.002--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009--Not Available
Headache17.14.01.001--
Hepatitis09.01.07.004--Not Available
Hepatomegaly09.01.05.001--Not Available
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hypokalaemia14.05.03.002--
Ichthyosis03.05.01.004; 23.01.02.002--Not Available
Ichthyosis acquired23.01.02.001--Not Available
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