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Nystatin

RxNorm 543546· NYSTATIN· TOPICAL

Polyene Antifungal [EPC] · Torrent Pharmaceuticals Limited

Indications and usage

INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage and administration

DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until health is complete.

Contraindications

CONTRAINDICATIONS Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of their components.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • nausea2,020
  • fatigue1,830
  • diarrhoea1,816
  • pneumonia1,654
  • dyspnoea1,511
  • off label use1,433
  • vomiting1,377
  • drug ineffective1,296
  • pain1,274
  • death1,204
  • pyrexia1,137
  • headache1,036
  • rash980
  • acute kidney injury962
  • cough956
  • asthenia947

Adverse reactions (label)

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream 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. )