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 Miconazole is indicated for the local treatment of oropharyngeal candidiasis in adult patients and for the adjunctive treatment of diaper dermatitis complicated by candidiasis in immunocompetent patients aged four weeks and older.[L14021, L14024] Miconazole is available as both a suppository and cream for the treatment of vaginal yeast infections and the relief of associated vulvar itching and irritation.[L14027] Lastly, miconazole cream is effective in treating athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm infections (tinea corporis),[L14033] pityriasis (formerly tinea) versicolor,[A203633] and cutaneous candidiasis.[A203630]
Marketing Status approved; investigational; vet_approved
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 51927-0102; 67777-316; 49452-4723; 17337-0529; 72742-2500; 61825-303; 51927-2094; 42669-073
UNII 7NNO0D7S5M
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
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)
Toxic epidermal necrolysis11.07.01.006; 10.01.01.006; 23.03.01.008; 12.03.01.015--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Vaginal discharge21.08.02.002--
Vaginal haemorrhage24.07.03.005; 21.08.01.001--
Vomiting07.01.07.003--
Vulvovaginal discomfort21.08.02.005--Not Available
Wheezing22.03.01.009--
Gingival pruritus07.09.13.011--Not Available
Vulvovaginal pruritus23.03.12.009; 21.08.02.004--Not Available
Infestation23.11.01.002; 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
Blood disorder01.05.01.004--Not Available
Hepatobiliary disease09.01.08.003--Not Available
Application site discomfort12.07.01.034; 08.02.01.034--Not Available
Regurgitation07.01.07.004--Not Available
Vulvovaginal burning sensation21.08.02.007--Not Available
Burning mouth syndrome07.05.05.013; 17.02.06.016--Not Available
Oropharyngeal pain07.05.05.004; 22.12.03.016--
Vulvovaginal pain21.08.02.009--
Vulvovaginal erythema23.03.06.017; 21.08.02.011--Not Available
Vulvovaginal swelling21.08.02.016--Not Available
Vulvovaginal inflammation21.14.02.014--Not Available
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