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)
Intestinal obstruction07.13.01.002--Not Available
Jaundice01.06.04.004; 23.03.03.030; 09.01.01.004--Not Available
Lymphadenopathy01.09.01.002--Not Available
Nausea07.01.07.001--
Neuralgia17.02.07.005--
Oedema14.05.06.010; 08.01.07.006--Not Available
Photosensitivity reaction23.03.09.003--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Skin discolouration23.03.03.005--Not Available
Somnolence19.02.05.003; 17.02.04.006--
Splenic infarction01.09.02.004; 24.04.08.024--Not Available
Vascular pain24.03.02.026--Not Available
Visual acuity reduced17.17.01.011; 06.02.10.012--
Visual impairment06.02.10.013--Not Available
Vomiting07.01.07.003--
Weight decreased13.15.01.005--
Embolism24.01.01.009--
Decreased appetite14.03.01.005; 08.01.09.028--
Cystitis noninfective20.03.02.001--
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