Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Miconazole nitrate
Drug ID BADD_D01458
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 D00882
MeSH ID D008825
PubChem ID 68553
TTD Drug ID D00AXJ
NDC Product Code 50090-2231; 50066-199; 79503-106; 60524-001; 17337-0530; 68016-073; 41520-616; 65197-103; 42669-071; 72189-345; 42213-398; 70518-2338; 55319-081; 51927-1154; 11673-982; 37808-242; 70000-0040; 23667-817; 23667-808; 0363-0730; 69842-988; 59726-988; 11701-045; 66267-960; 11523-0544; 0363-0199; 23667-812; 11523-1272; 49706-5971; 69842-950; 72288-070; 43689-0025; 63736-026; 63187-885; 50923-1213; 41520-825; 11014-0358; 68754-201; 51672-2070; 0113-0916; 51672-2001; 49035-199; 56062-081; 68599-0207; 11523-4140; 23667-804; 55301-211; 21130-040; 44577-205; 53329-169; 51927-0099; 11509-0081; 37808-199; 0363-0081; 68016-291; 49781-064; 52000-021; 50066-277; 0472-0730; 52935-0009; 11014-0343; 50090-5674; 0536-1134; 41250-982; 11523-4327; 63868-198; 49348-833; 53329-162; 49035-730; 59088-244; 38779-0038; 0713-0252; 30142-081; 70000-0009; 68599-0206; 36800-199; 0113-0214; 37205-589; 49348-689; 11701-067; 49035-737; 12258-242; 51316-005; 72071-101; 68016-731; 52000-061; 68071-2657; 68754-200; 12578-488; 24385-590; 49348-355; 0904-5415; 50066-070; 69396-014; 63736-013; 49348-530; 21130-737; 72288-825; 72654-001; 11014-0045; 36800-081; 0363-0637; 11673-199; 68071-2419; 63347-502; 41520-222; 72288-199; 68016-070; 59779-773; 11086-040; 0316-0231; 21130-121; 0113-0081; 61269-730; 63736-023; 11509-0825; 11523-0919; 62654-147; 42669-072; 55315-737; 86014-205; 63736-010; 0363-1497; 68981-035; 0363-0557; 59208-001; 30142-737; 55545-0400; 23667-819; 59726-989; 0113-9001; 21130-341; 68788-7519; 30142-982; 50090-4356; 70000-0025; 36800-782; 62172-202; 0904-7734; 61269-736; 0363-0737; 29784-145; 0713-0197; 49035-345; 69256-825; 59779-737; 61269-735; 49035-731; 0472-1738; 58980-818; 51672-2035; 59779-839; 0472-0735; 51927-0100; 0113-0825; 63736-017; 0113-7070; 73921-012; 70518-3202; 25119-0824; 37808-825; 37808-928; 0316-0232; 0316-0225; 55315-815; 51552-0122; 50090-2718; 46063-552; 11673-737; 41520-916; 71358-077; 41520-154; 43285-0288; 49035-347; 68788-7374; 63736-019; 21130-102; 41250-199; 51824-078; 49452-4775; 49706-5977; 0363-2070; 11822-0199; 69256-081; 12258-241; 21130-825; 55301-916; 69070-304; 41250-081; 30142-825; 71730-070; 59088-478; 11822-0800; 37205-583; 0363-5201; 24385-606; 69740-328; 63347-810; 69740-329; 0363-5203; 0113-7825; 16864-040; 36800-070; 59088-442; 11701-038; 17518-857; 49706-5972; 11822-1104; 11673-391; 50090-5607; 30142-199; 55910-698; 63736-025; 53329-171; 11673-825; 53329-080; 53329-774; 11822-7310; 0113-7199; 59779-199; 68788-7917; 11673-049; 41250-825; 63347-503; 36800-825; 49348-872; 68788-8107; 49035-341; 43553-0003; 21130-982; 63736-015; 41250-497; 72288-497; 41163-825; 0884-0293; 62991-1104; 73736-115; 55910-081; 24909-202; 11014-0058; 41163-081; 53329-079; 46122-577; 49348-645; 63736-532
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 C18H15Cl4N3O4
CAS Registry Number 22832-87-7
SMILES C1=CC(=C(C=C1Cl)Cl)COC(CN2C=CN=C2)C3=C(C=C(C=C3)Cl)Cl.[N+](=O)(O)[O-]
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)
Abdominal pain07.01.05.002--
Chills15.05.03.016; 08.01.09.001--
Headache17.14.01.001--
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Skin irritation23.03.04.009--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vaginal discharge21.08.02.002--
Vomiting07.01.07.003--
Vulvovaginal pruritus23.03.12.009; 21.08.02.004--Not Available
Vulvovaginal burning sensation21.08.02.007--Not Available
Vulvovaginal pain21.08.02.009--
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