Nystatin

Mechanism-of-action class: Ergosterol Synthesis Inhibitors.

• Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.

• Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.contraindicated

Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. [see PRECAUTIONS: General ].

Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Metabolism

Nystatin is not absorbed from intact skin or mucous membrane.

• Apr 14, 1971NDANDA050299Chartwell Molecules
• May 25, 1976ANDAANDA061966Cosette
• Dec 11, 1979ANDAANDA062225Padagis Us
• Dec 22, 1983ANDAANDA062474Heritage
• Jan 16, 1984ANDAANDA062506Teva
• Feb 13, 1984ANDAANDA062472Padagis Us
• Oct 29, 1984ANDAANDA062512Pharmobedient
• Nov 13, 1987ANDAANDA062840Actavis Mid Atlantic

1. 1Nausea2,0217.5%
2. 2Fatigue1,8316.8%
3. 3Diarrhoea1,8166.8%
4. 4Pneumonia1,6566.2%
5. 5Dyspnoea1,5115.6%
6. 6Off Label Use1,4335.3%
7. 7Vomiting1,3775.1%
8. 8Drug Ineffective1,2964.8%
9. 9Pain1,2744.7%
10. 10Death1,2044.5%
11. 11Pyrexia1,1384.2%
12. 12Headache1,0363.9%
13. 13Rash9803.6%
14. 14Acute Kidney Injury9623.6%
15. 15Cough9563.6%

Recent PubMed references pinned to Nystatin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Fabrication and Evaluation of PVA-NYS-THY Nanofiber Scaffolds as Antifungal Agents Against Fluconazoleresistant Candida glabrata.
  Archives of Razi Institute · 2025 · Romina A, Mohaddeseh L, Mansour B, et al.
  PMID 42226981DOI 10.32598/ARI.80.5.3399
• Systemic toxicity assessment of tissue conditioners modified with nystatin and chlorhexidine in a rat model of denture stomatitis.
  Journal of applied oral science : revista FOB · 2026 · Moraes GS, Albach T, Sugio CYC, et al.
  PMID 42207095DOI 10.1590/1678-7765-2025-0811
• Label-Free Visualization of the Antifungal Polyene Drug, Nystatin, in Biological Membranes Using Raman Microscopy.
  Analytical chemistry · 2026 · Tipping WJ, Bilal Z, Wells RC, et al.
  PMID 42081300DOI 10.1021/acs.analchem.5c07342
• Combination treatment of topical nystatin and systemic meglumine antimoniate in the BALB/c - Leishmania(Leishmania) amazonensis model.
  Experimental parasitology · 2026 · Silva-Figueiredo M, Castro Côrtes LM, Dias-Lopes G, et al.
  PMID 41932422DOI 10.1016/j.exppara.2026.109133
• Repurposing an Antifungal Drug as an Effective Insulin Aggregation Inhibitor.
  Chemistry, an Asian journal · 2026 · Das A, Dalabehera NR, Pahal S, et al.
  PMID 41875250DOI 10.1002/asia.70704
• Synergistic Antifungal Activity of Zinc Pyrithione and Nystatin against Multi-Drug-Resistant Candida (Candidozyma) auris: Evidence from In Vitro and In Vivo Models.
  ACS infectious diseases · 2026 · Pimentel LR, Lucini F, Coferri LC, et al.
  PMID 41746963DOI 10.1021/acsinfecdis.5c00822
• Scanning Electrochemical Microscopy of Nystatin-Treated Yeast Used for Biofuel Cells.
  Sensors (Basel, Switzerland) · 2026 · Blazevic K, Zinovicius A, Rozene J, et al.
  PMID 41600401DOI 10.3390/s26020605
• Research and Application of the Polyene Macrolide Antibiotic Nystatin.
  Molecules (Basel, Switzerland) · 2026 · Liu X, Zhuo J, Chen Z, et al.
  PMID 41599380DOI 10.3390/molecules31020330

The 10 most recently updated of 64 ClinicalTrials.gov registrations naming Nystatin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027)
  Recruiting · Phase 1 · Phase 2 · Interventional · 32 enrolled · Merck Sharp & Dohme LLC
  NCT06637423updated 2026-06-12
• A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015)
  Active not recruiting · Phase 3 · Interventional · 450 enrolled · Merck Sharp & Dohme LLC
  NCT06356311updated 2026-02-27
• Precision Medicine Approach for Early Dementia & Mild Cognitive Impairment
  Completed · Phase 3 · Interventional · 73 enrolled · Alzheimer's Prevention and Reversal Project, Inc.
  NCT05894954updated 2026-02-18
• A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
  Recruiting · Phase 1 · Interventional · 42 enrolled · Astellas Institute for Regenerative Medicine
  NCT03178149updated 2026-01-13
• Safety and Efficacy Trial of TV5M01 for Radiation-Induced Mucositis in Head and Neck Cancer Patients.
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 40 enrolled · Fundacion Clinica Valle del Lili
  NCT06875791updated 2025-04-01
• Efficacy of Topical Treatment With Clobetasol in Symptomatic Oral Lichen Planus.
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 90 enrolled · Malmö University
  NCT04364555updated 2024-12-04
• Oral Mucositis Management in Pediatric Oncology Patients
  Completed · Interventional · 30 enrolled · Zubeyde Ezgi Ercelik
  NCT06711315updated 2024-12-02
• Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against Pathogens
  Active not recruiting · Phase 1 · Interventional · 200 enrolled · Danylo Halytsky Lviv National Medical University
  NCT06616168updated 2024-09-27
• Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy
  Completed · Phase 1 · Interventional · 45 enrolled · American University of Beirut Medical Center
  NCT03399331updated 2024-08-07
• Processed Amniotic Fluid (pAF) for the Treatment of Chronic Wounds
  Terminated · Phase 1 · Phase 2 · Interventional · 1 enrolled · University of Utah
  NCT04438174updated 2024-06-07

Frequently asked questions

How does Nystatin work?

Mechanism-of-action class: Ergosterol Synthesis Inhibitors.

What is Nystatin used for?

According to FDA labeling, Nystatin carries indications including: Nyamyc® (Nystatin Topical Powder, USP) is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nyamyc® (Nystatin Topical Powder, USP) is not indicated for systemic, oral, intravaginal or ophthalmic use.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Nystatin?

Nystatin is classified as Antibiotics, Polyene Antifungal, Ergosterol Synthesis Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Nystatin?

Nystatin is marketed under brand names including Bio-Statin, Nyamyc, Nystop.

What are the contraindications for Nystatin?

Nystatin labeling lists contraindications including: Nyamyc® (Nystatin Topical Powder, USP) is contraindicated in patients with a history of hypersensitivity to any of its components.. Always consult the full prescribing information and a clinician.