Nystatin
Generic: NYSTATIN
Basic Information
Manufacturer
AvKARE
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
8fd35f97-5405-2160-ca0f-35034ecd5a92
Indications & Usage
INDICATIONS AND USAGE Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
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 nonspecific myalgia have also been rarely reported.
To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; 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 nonspecific myalgia have also been rarely reported.
To report SUSPECTED ADVERSE REACTIONS contact AvKARE at 1-855-361-3993; email drugsafety@avkare.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.