Nystatin
Nystaform, Nystatin, Nystop (nystatin) is a small molecule pharmaceutical. Nystatin was first approved as Nystaform on 1982-01-01. It is used to treat chronic mucocutaneous candidiasis, cutaneous candidiasis, mycoses, oral candidiasis, and vulvovaginal candidiasis in the USA.
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Commercial
Trade Name
FDA
EMA
Klayesta, Nilstat, Nystatin, Nystop (discontinued: Candex, Mycostatin, Mykinac, Nilstat, Nysert, Nystatin, Nystex)
CombinationsNystatin triamcinolone (discontinued: Myco-triacet, Mycolog-ii, Mykacet, Mytrex f, Nystaform, Nystatin triamcinolone, Nystatin-triamcinolone)
Drug Products
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Abbreviated New Drug Application (ANDA)
Nystatin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NILSTAT | Chartwell Pharmaceuticals | N-050299 RX | 1982-01-01 | 1 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| klayesta | ANDA | 2025-12-17 |
| mycostatin | ANDA | 2026-03-17 |
| nyamyc | ANDA | 2025-07-09 |
| nystatin | ANDA | 2026-07-24 |
| nystatin and triamcinolone | ANDA | 2011-05-10 |
| nystatin and triamcinolone acetonide | ANDA | 2026-03-02 |
| nystatin cream | ANDA | 2026-01-12 |
| nystatin oral suspension | ANDA | 2026-02-06 |
| nystatin topical powder | ANDA | 2023-08-10 |
| nystop | ANDA | 2026-07-14 |
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Indications
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Agency Specific
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ATC Codes
A: Alimentary tract and metabolism drugs
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07A: Intestinal antiinfectives
— A07AA: Antibiotics, intestinal
— A07AA02: Nystatin
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AA: Antifungal antibiotics, topical
— D01AA01: Nystatin
G: Genito urinary system and sex hormones
— G01: Gynecological antiinfectives and antiseptics
— G01A: Antiinfectives and antiseptics, excl. combinations with corticosteroids
— G01AA: Antibiotics, gynecological
— G01AA01: Nystatin
— G01AA51: Nystatin, combinations
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Clinical
Clinical Trials
67 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 3 | 4 | 2 | 1 | 5 | 14 |
| Candidiasis | D002177 | — | B37 | — | 1 | 3 | 1 | 4 | 9 |
| Infections | D007239 | EFO_0000544 | — | 2 | — | 3 | 1 | 2 | 8 |
| Mucositis | D052016 | EFO_1001898 | — | 2 | 1 | 1 | 1 | 4 | 8 |
| Communicable diseases | D003141 | — | — | 2 | — | 2 | 1 | — | 5 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | 1 | 1 | 1 | 3 |
| Vaginitis | D014627 | EFO_0005757 | N76 | — | — | 2 | 1 | — | 3 |
| Birth weight | D001724 | EFO_0004344 | — | — | — | — | 3 | — | 3 |
| Critical illness | D016638 | — | — | — | — | 1 | 1 | — | 2 |
| Burns | D002056 | — | T30.0 | — | 1 | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | 2 | 2 | — | 4 | 8 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | 1 | — | 4 | 7 |
| Oral lichen planus | D017676 | — | — | 1 | 2 | 1 | — | 3 | 6 |
| Lichen planus | D008010 | — | L43 | 1 | 2 | 1 | — | 2 | 5 |
| Denture stomatitis | D013282 | EFO_1000893 | K12.1 | — | 3 | 1 | — | 1 | 5 |
| Head and neck neoplasms | D006258 | — | — | 2 | 1 | 1 | — | 1 | 4 |
| Bacterial vaginosis | D016585 | EFO_0003932 | — | 1 | — | 2 | — | — | 3 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | 2 | — | — | 2 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 1 | 2 | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | 1 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Aphthous stomatitis | D013281 | EFO_0003938 | K12.0 | 1 | 1 | — | — | 1 | 3 |
| Wounds and injuries | D014947 | — | T14.8 | 2 | 1 | — | — | — | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | — | 1 |
| Kidney transplantation | D016030 | — | — | 1 | 1 | — | — | — | 1 |
| Cross infection | D003428 | — | — | — | 1 | — | — | — | 1 |
| Anastomotic leak | D057868 | — | — | — | 1 | — | — | — | 1 |
| Hiv seropositivity | D006679 | — | — | — | 1 | — | — | — | 1 |
| Non-muscle invasive bladder neoplasms | D000093284 | — | — | 1 | 1 | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | 1 | — | — | — | 1 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 2 | — | — | — | 2 | 4 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Otomycosis | D059249 | — | — | 1 | — | — | — | — | 1 |
| Dental caries | D003731 | EFO_0003819 | K02 | 1 | — | — | — | — | 1 |
| Aids-related complex | D000386 | EFO_0007137 | B20 | 1 | — | — | — | — | 1 |
| Wound infection | D014946 | — | — | 1 | — | — | — | — | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | 1 | — | — | — | — | 1 |
| Geographic atrophy | D057092 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 2 | 2 |
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 1 | 1 |
| Conization | D019092 | — | — | — | — | — | — | 1 | 1 |
| Low-level light therapy | D028022 | — | — | — | — | — | — | 1 | 1 |
| Periodontal diseases | D010510 | — | K05.6 | — | — | — | — | 1 | 1 |
| Neoplasms | D009369 | — | C80 | — | — | — | — | 1 | 1 |
| Burning mouth syndrome | D002054 | EFO_1000850 | — | — | — | — | — | 1 | 1 |
| Herpesviridae infections | D006566 | EFO_0007309 | B00.4 | — | — | — | — | 1 | 1 |
| Patient compliance | D010349 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nystatin |
| INN | nystatin |
| Description | Nystatin, sold under the brand name Mycostatin among others, is an antifungal medication. It is used to treat Candida infections of the skin including diaper rash, thrush, esophageal candidiasis, and vaginal yeast infections. It may also be used to prevent candidiasis in those who are at high risk. Nystatin may be used by mouth, in the vagina, or applied to the skin.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@@H]1OC(=O)C[C@H](O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@]2(O)C[C@H](O)[C@@H](C(=O)O)[C@H](C[C@@H](O[C@@H]3O[C@H](C)[C@@H](O)[C@H](N)[C@@H]3O)/C=C/C=C/C=C/C=C/CC/C=C/C=C/[C@H](C)[C@@H](O)[C@H]1C)O2 |
Identifiers
| PDB | — |
| CAS-ID | 1400-61-9 |
| RxCUI | 7597 |
| ChEMBL ID | CHEMBL450895 |
| ChEBI ID | — |
| PubChem CID | 14960 |
| DrugBank | DB00646 |
| UNII ID | BDF1O1C72E (ChemIDplus, GSRS) |
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Nystatin
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Diphenhydramine
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Nystatin
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Nystatin
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Triamcinolone
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Safety
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3,039 adverse events reported
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