Nystatin Oral Suspension
Generic: NYSTATIN
Basic Information
Manufacturer
Xttrium Laboratories, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
4a670371-d373-1ba6-e063-6394a90a13b6
Indications & Usage
INDICATIONS AND USAGE Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc.
at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Xttrium Laboratories, Inc.
at 1-800-587-3721 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.