Nystatin
RxNorm 312059· NYSTATIN· ORAL
Polyene Antifungal [EPC] · Chartwell RX, LLC
Indications and usage
INDICATIONS AND USAGE Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Dosage and administration
DOSAGE AND ADMINISTRATION The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.
Contraindications
CONTRAINDICATIONS Nystatin tablets are 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 Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General. ) Gastrointestinal Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC. at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
View more: Full FDA label on DailyMed →Label effective 20251217