Home FDA labels 8d9b172d-a817-43b1-9cd9-24243b311f28 Nystatin openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
Brand name Nystatin
Generic name NYSTATIN
Manufacturer A-S Medication Solutions
Product type HUMAN PRESCRIPTION DRUG
SPL set ID e069d495-7f1a-4970-8f4d-aa93d124b3fc
SPL ID 8d9b172d-a817-43b1-9cd9-24243b311f28
Version 9
Effective date 2023-02-04
Source export date 2026-10-12
Source partition 12
Source file https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:52:03 Harmonized routes table Harmonized routes ORAL
Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
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Adverse reactions sections page 1 of 1 · 1 matching rows.
adverse reactions 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 non-specific myalgia have also been rarely reported.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.