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What the label lists and what reports show

Nystatin and triamcinolone side effects

Nystatin and triamcinolone's FDA label lists its adverse reactions in its own words. FAERS holds 108 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is application site pain (8 reports).

  • Generic listed

Check it at the source: the nystatin and triamcinolone FDA label on DailyMed (effective January 12, 2026, Crown Laboratories); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

A single case (approximately one percent of patients studied) of acneiform eruption occurred with use of combined nystatin and triamcinolone acetonide in clinical studies. Nystatin is virtually nontoxic and nonsensitizing and is well tolerated by all age groups, even during prolonged use. Rarely, irritation may occur. The following local adverse reactions are reported infrequently with topical corticosteroids (reactions are listed in an approximate decreasing order of occurrence): burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, perioral secondary infection, skin atrophy, striae and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/

Source: FDA drug label, Crown Laboratories, effective January 12, 2026 (SPL set 54aae5d3-e482-4da0-a1b2-0ed70e6c2915), via openFDA; the full label on DailyMed

What do FAERS reports show?

108 reports list nystatin and triamcinolone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 6 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, none is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)23
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)11
  • Application Site Pain8
  • Pruritus8
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)6
  • Diarrhoea5
  • Off Label Use (a use or a product term, not a reaction)5
  • Pain5
  • Rash5
  • Accidental Exposure To Product4
  • Application Site Pruritus4
  • Burning Sensation4
  • Drug Effective For Unapproved Indication (a use or a product term, not a reaction)4
  • Fatigue4
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)4
  • Nausea4
  • Urinary Tract Infection4
  • Weight Decreased4
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)4
  • Application Site Erythema3
  • Condition Aggravated (a use or a product term, not a reaction)3
  • Expired Product Administered (a use or a product term, not a reaction)3
  • Headache3
  • Incorrect Route Of Product Administration3
  • Joint Swelling3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Nystatin and triamcinolone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions