Nystatin
Generic: NYSTATIN
Basic Information
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
28b4e26e-206a-4e8a-abfe-774b780e91c3
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 Pharmaceutical Associates, Inc.
at 1-800-845-8210 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 Pharmaceutical Associates, Inc.
at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.