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Substance · official US FDA label

Nystatine (nystatin)

27 medicines listed on Vimpia contain it, alone or combined. Below, the official US FDA label for nystatin, unchanged.

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This is a US label.

The official US FDA label for nystatin, effective August 19, 2026, describes products sold in the United States. The medicine sold in DR Congo may differ in strength, form or approved uses: ask a pharmacist or a doctor.

Official US FDA label for nystatin

Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. The full label on DailyMed.

Uses

INDICATIONS AND USAGE Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Dosage

US dosage, for products sold in the United States. For a medicine bought in DR Congo, follow its box, its leaflet or your pharmacist.

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.

Side effects

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 Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Medicines that contain it

Names as they are sold. A medicine without an English page links to its French page.

Sources

  • ●Labels: U.S. Food and Drug Administration, openFDA (public domain). Data provided by the U.S. Food and Drug Administration (openFDA), unchanged. DailyMed.
  • ●English names of substances: RxNorm, U.S. National Library of Medicine.
  • ●Marketing authorizations: register of the ACOREP, DR Congo.
  • ●Essential medicines: national list of essential medicines of DR Congo (LNME).
  • ●Composition: public medicines database of France (BDPM), ANSM, open licence.

Public information, for reference only: it does not replace the advice of a pharmacist or a doctor. Vimpia writes nothing about how to use a medicine and translates nothing: the label is the US FDA's, unchanged; names, composition and authorizations come from the official sources above.