Note: This document contains side effect information about nystatin topical. Some dosage forms listed on this page may not apply to the brand name Pediaderm AF.

Applies to nystatin topical: topical cream, topical ointment, topical powder.

Serious side effects of Pediaderm AF

Along with its needed effects, nystatin topical (the active ingredient contained in Pediaderm AF) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking nystatin topical:

• Skin irritation not present before use of this medicine

For Healthcare Professionals

Applies to nystatin topical: topical cream, topical kit, topical ointment, topical powder, vaginal tablet.

Dermatologic

Dermatologic side effects associated with nystatin topical (the active ingredient contained in Pediaderm AF) powder, cream, and ointment have included skin irritation, burning, itching, rash, eczema, and pain on application in less than 0.1% of patients.^[Ref]

Genitourinary

Genitourinary side effects associated with nystatin vaginal tablets have included vaginal irritation, burning, and itching. At least one case of severe vulvovaginitis has also been reported.^[Ref]

A 64-year-old female experienced severe vulvovaginitis while receiving intravaginal nystatin therapy for Candida glabrata infection. She was administered nystatin vaginal tablets, 100,000 units twice daily for 14 days. She returned immediately after having completed the course complaining of intense skin rash in the vulvar area accompanied by severe irritation, burning, and itching. Therapy with a hydrocortisone cream and intramuscular betamethasone dipropionate was initiated. A week later, she had marked improvement with clearing of the vulvovaginal erythema and edema.^[Ref]

Hypersensitivity

Hypersensitivity side effects associated with nystatin topical (the active ingredient contained in Pediaderm AF) powder, cream, and ointment have included allergic reactions and allergic contact dermatitis in less than 0.1% of patients. Stevens-Johnson syndrome has also been reported.