Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Efinaconazole
Drug ID BADD_D00750
Description Efinaconazole is a 14 alpha-demethylase inhibitor indicated in the treatment of fungal infection of the nail, known as onychomycosis. It was approved for use in Canada and the USA in 2014 and is marketed by Valeant Pharmaceuticals North America LLC under the name Jublia.
Indications and Usage Indicated in the treatment of fungal infection of the nail, known as onychomycosis.
Marketing Status approved
ATC Code D01AC19
DrugBank ID DB09040
KEGG ID D10021
MeSH ID C431707
PubChem ID 489181
TTD Drug ID D0G4BI
NDC Product Code 46438-0644; 76397-018; 65015-896; 66039-930; 46016-1642; 66064-1024; 68259-1314; 70600-001; 51686-0012; 76397-017; 0187-5400; 51265-541; 51557-001; 76397-006; 58175-0606
UNII J82SB7FXWB
Synonyms efinaconazole | KP 103 | KP103 | KP-103 | Jublia
Chemical Information
Molecular Formula C18H22F2N4O
CAS Registry Number 164650-44-6
SMILES CC(C(CN1C=NC=N1)(C2=C(C=C(C=C2)F)F)O)N3CCC(=C)CC3
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)
Application site dermatitis23.03.04.014; 12.07.01.018; 08.02.01.0180.000433%Not Available
Application site erythema23.03.06.005; 12.07.01.001; 08.02.01.0010.002772%Not Available
Application site irritation08.02.01.003; 12.07.01.0030.001671%Not Available
Application site pain12.07.01.004; 08.02.01.0040.002536%Not Available
Application site pruritus23.03.12.004; 12.07.01.005; 08.02.01.0050.000669%Not Available
Application site rash12.07.01.016; 08.02.01.016; 23.03.13.008--Not Available
Blister23.03.01.001; 12.01.06.0020.007354%Not Available
Chest pain08.01.08.002; 02.02.02.011; 22.12.02.003--Not Available
Condition aggravated08.01.03.0040.000433%Not Available
Dermatitis23.03.04.0020.001435%Not Available
Dermatitis contact23.03.04.004; 12.03.01.040; 10.01.01.0030.001199%Not Available
Drug ineffective08.06.01.006--Not Available
Dry skin23.03.03.0010.000669%
Erythema23.03.06.0010.005781%Not Available
Hypersensitivity10.01.03.0030.001003%
Hypoaesthesia23.03.03.081; 17.02.06.023--Not Available
Ingrowing nail23.02.05.0110.000669%Not Available
Instillation site pain08.02.01.008; 12.07.01.008--Not Available
Nail discolouration23.02.05.0010.005682%
Nail disorder23.02.05.0020.001003%
Pain08.01.08.0040.001337%
Pain in extremity15.03.04.0100.000669%
Paronychia11.02.01.054; 23.11.04.006--
Pruritus23.03.12.0010.001337%
Rash23.03.13.0010.003775%Not Available
Rash erythematous23.03.13.0290.000669%Not Available
Scab23.03.03.004--Not Available
Skin disorder23.03.03.0070.000433%Not Available
Skin exfoliation23.03.07.0030.001770%Not Available
Skin irritation23.03.04.0090.001337%Not Available
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