Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Miconazole
Drug ID BADD_D01457
Description Miconazole is a broad-spectrum azole antifungal with some activity against Gram-positive bacteria as well.[A203636] It is widely used to treat mucosal yeast infections, including both oral and vaginal infections; although intravenous miconazole is no longer available, a wide variety of suppositories, creams, gels, and tablet-based products are available.[L14021, L14024, L14027, L14033, L14396] Miconazole is thought to act primarily through the inhibition of fungal CYP450 14α-lanosterol demethylase activity.[A203636, A203639] Miconazole was first synthesized in 1969 and first granted FDA approval on January 8, 1974, for sale by INSIGHT Pharmaceuticals as a topical cream.[A214523, L14021] It is currently available as a variety of prescription and over the counter products. Despite having been in clinical use for an extended period, resistance to miconazole among susceptible organisms is relatively low.[A203636]
Indications and Usage For topical application in the treatment of tinea pedis (athlete’s foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis (moniliasis), and in the treatment of tinea versicolor.
Marketing Status Prescription; Discontinued; OTC
ATC Code A01AB09; A07AC01; D01AC02; G01AF04; J02AB01; S02AA13
DrugBank ID DB01110
KEGG ID D00416
MeSH ID D008825
PubChem ID 4189
TTD Drug ID D00AXJ
NDC Product Code 49452-4723; 17337-0529; 67777-316; 51927-0102; 51927-2094; 61825-303; 72742-2500; 55545-0411; 38779-0239
Synonyms Miconazole | R-14,889 | R 14,889 | R14,889 | Miconazole Nitrate | Nitrate, Miconazole | Miconasil Nitrate | Nitrate, Miconasil | Monistat | Brentan | Dactarin
Chemical Information
Molecular Formula C18H14Cl4N2O
CAS Registry Number 22916-47-8
SMILES C1=CC(=C(C=C1Cl)Cl)COC(CN2C=CN=C2)C3=C(C=C(C=C3)Cl)Cl
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)
Immune system disorder10.02.01.001--Not Available
Infection11.01.08.002--Not Available
Instillation site pain12.07.01.008; 08.02.01.008--Not Available
Lymphopenia01.02.02.002--Not Available
Malaise08.01.01.003--
Mouth ulceration07.05.06.004--Not Available
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Neutropenia01.02.03.004--Not Available
Oral discomfort07.05.05.001--Not Available
Oral pain07.05.03.002--
Pain08.01.08.004--
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Skin irritation23.03.04.009--Not Available
Stevens-Johnson syndrome12.03.01.014; 23.03.01.007; 11.07.01.005; 10.01.03.020--
Stomatitis07.05.06.005--
Tongue ulceration07.14.01.003--Not Available
Tooth disorder07.09.05.001--Not Available
Toothache07.09.06.001--
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Upper respiratory tract infection11.01.13.009; 22.07.03.011--
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Gingival pruritus07.05.05.012--Not Available
Infestation23.09.05.001; 11.09.01.001--Not Available
Mediastinal disorder22.09.03.001--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Ill-defined disorder08.01.03.049--Not Available
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