Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Clotrimazole
Drug ID BADD_D00509
Description This drug is a broad spectrum antimycotic or antifungal agent. Clotrimazole's antimycotic properties were discovered in the late 1960s [A174094]. Clotrimazole falls under the _imidazole_ category of _azole_ antifungals, possessing broad-spectrum antimycotic activity [A174094]. It is available in various preparations, including creams, pessaries, and troche formulations (slowly dissolving tablets). As well as its antifungal activity, clotrimazole has become a drug of interest in treating several other diseases such as sickle cell disease, malaria and some cancers [A174094]. The minimal side effect profile of this drug and its uncomplicated metabolic profile have led it to gain widespread acceptance for the treatment of mycotic outbreaks such as vaginal yeast infections as well as athlete's foot [A174097].
Indications and Usage **Topical preparations** Clotrimazole topical cream is indicated for the topical treatment of the following dermal infections [F3088], [F3121]: Tinea pedis, tinea cruris, and tinea corporis due to _Trichophyton rubrum_, _Trichophyton mentagrophytes_, _Epidermophyton floccosum_ Candidiasis due to _Candida albicans_ Tinea versicolor due to _Malassezia furfur_ Diaper rash infected by _Candida albicans_ In some preparations, clotrimazole may be combined with betamethasone dipropionate, a corticosteroid [F3121]. **Oral preparations** The oral troche preparation is indicated for the local treatment of oropharyngeal candidiasis [FDA label]. It is also indicated as a prophylactic drug to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions such as chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation [FDA label]. Troche preparations are not indicated for the treatment of any systemic mycoses [FDA label].
Marketing Status approved; vet_approved
ATC Code A01AB18; D01AC01; G01AF02
DrugBank ID DB00257
KEGG ID D00282
MeSH ID D003022
PubChem ID 2812
TTD Drug ID D09GOS
NDC Product Code 79503-105; 48087-0084; 49706-1545; 51552-0138; 79572-010; 11673-504; 11673-910; 41520-305; 52261-5801; 69822-254; 69842-866; 73076-114; 13746-104; 24885-777; 38779-0019; 62512-0064; 11527-071; 11822-1110; 24909-106; 24909-207; 24909-208; 50382-025; 51672-2037; 51672-2062; 54633-018; 55758-102; 55910-340; 0295-1363; 0363-2062; 63868-690; 67091-196; 67234-009; 67234-014; 68016-414; 68071-2693; 68784-301; 68788-7402; 68788-8330; 69771-032; 0574-0107; 71399-0500; 79481-0014; 62512-0044; 11523-1125; 21130-870; 24909-212; 29978-918; 36800-495; 59779-510; 59779-712; 67510-0638; 68016-035; 70518-2932; 71205-738; 55910-343; 59779-305; 59779-514; 63868-259; 69396-087; 80684-039; 76003-0329; 21130-210; 0113-0857; 41250-421; 45802-434; 51672-1275; 53002-9080; 59088-441; 61360-2037; 68016-859; 68071-3416; 68927-3490; 69070-303; 69396-001; 0054-4146; 11822-0350; 24385-110; 24385-205; 24909-026; 24909-104; 24909-218; 30142-510; 49035-253; 51672-2003; 52389-600; 54633-314; 0295-6307; 63187-501; 68071-4026; 68788-7682; 68788-9665; 70000-0542; 70403-925; 72127-0806; 0904-7822; 48087-0086; 49452-2148; 62512-0060; 11822-3078; 11822-3423; 20276-105; 24909-102; 30142-305; 36800-857; 41415-056; 51672-1260; 63187-559; 68462-181; 68788-8216; 0536-1272; 73538-001; 49964-0014; 13630-0092; 41163-963; 49035-812; 49035-837; 49348-379; 50090-0614; 51824-063; 53002-8400; 54473-096; 55301-857; 61269-220; 0363-2105; 0363-2107; 65923-052; 66267-980; 66977-023; 67510-0657; 68071-2315; 68788-8091; 69848-001; 70673-747; 70795-8020; 71205-438; 0054-8146; 82460-344; 49706-0545; 68981-045; 11523-0963; 11523-6549; 11673-062; 21130-287; 24909-215; 37808-305; 50090-5931; 50804-143; 0363-0220; 0363-1857; 0363-2109; 70518-3396; 70677-1002; 71205-432; 72127-0801; 17337-0512; 43285-0043; 48087-0088; 62991-1035; 11673-857; 36800-508; 47832-071; 49348-793; 50066-111; 51672-2002; 52389-733; 55315-008; 55621-003; 68071-2317; 68071-2614; 69842-062; 70000-0493; 0536-1181; 0536-1265; 71205-434; 71399-0501; 77338-312; 10135-671; 62512-0066; 11822-0220; 11822-0351; 24909-100; 24909-203; 24909-214; 41250-745; 0168-0133; 49348-279; 51824-093; 52389-647; 52410-3024; 53943-990; 55614-650; 59088-476
UNII G07GZ97H65
Synonyms Clotrimazole | Klotrimazole | Mycelex | FB b 5097 | Lotrimin | Bay b 5097 | Canesten | Kanesten
Chemical Information
Molecular Formula C22H17ClN2
CAS Registry Number 23593-75-1
SMILES C1=CC=C(C=C1)C(C2=CC=CC=C2)(C3=CC=CC=C3Cl)N4C=CN=C4
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)
Muscle spasms15.05.03.004--
Nausea07.01.07.001--
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.004--
Panic attack19.06.04.0010.000160%-
Pollakiuria20.02.02.007--
Pruritus23.03.12.0010.000401%
Pyrexia08.05.02.0030.000160%
Rash23.03.13.0010.000706%-
Skin exfoliation23.03.07.003---
Skin irritation23.03.04.009---
Tachycardia02.03.02.0070.000160%-
Urticaria10.01.06.001; 23.04.02.001--
Vaginal discharge21.08.02.002--
Vaginal haemorrhage21.08.01.001; 24.07.03.0050.000401%
Vomiting07.01.07.003--
Vulvovaginal discomfort21.08.02.0050.000160%-
Vanishing bile duct syndrome09.02.03.0030.000160%-
Haemorrhage24.07.01.002---
Cystitis noninfective20.03.02.001--
Skin haemorrhage23.06.07.001; 24.07.01.103---
Vulvovaginal burning sensation21.08.02.007---
Vulvovaginal pain21.08.02.0090.000353%
Vulvovaginal swelling21.08.02.0160.000353%-
Drug-induced liver injury09.01.07.023; 12.03.01.0440.000241%-
Illness08.01.03.0910.000241%-
Therapeutic product ineffective08.06.01.057---
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ADReCS-Target
Drug Name ADR Term Target
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