nystatin
Brand names: Mycostatin
Nystatin topical powder is an antifungal medicine. It treats fungal infections on your skin.
Drug Shortage Alert
nystatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Upsher-Smith Laboratories, LLC.
View all drug shortages →Drug Pricing (NADAC)
Generic Price
$0.14/unit
Generic Available
Yes (42 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats skin infections caused by Candida, a type of fungus.
Common side effects
Allergic reactions, Burning, Itching
Key warnings
You should not use this medicine if you are allergic to any of its ingredients.
How It Works
Nystatin is an antifungal medicine. It works by killing the fungus or stopping its growth. This helps to clear up the infection on your skin.
How to Take It
Apply the powder to the infected skin two or three times each day. Keep using it until the infection is completely gone. If you have a fungal infection on your feet, put the powder on your feet and inside your shoes.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if nystatin topical powder is harmful to an unborn baby or passes into breast milk.
Missed Dose
Apply the missed dose as soon as you remember. Then, continue with your regular schedule.
Storage
Store at room temperature (68° to 77°F). Keep the container tightly closed and out of reach of children. Avoid excessive heat.
Side Effects (from patient reports)
Based on 14,990 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 26,244 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
26,244
Death-Related Reports
3,637
Hospitalization Reports
11,775
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | NAUSEA | 1,963 |
| 2 | FATIGUE | 1,799 |
| 3 | DIARRHOEA | 1,786 |
| 4 | PNEUMONIA | 1,613 |
| 5 | DYSPNOEA | 1,483 |
| 6 | OFF LABEL USE | 1,376 |
| 7 | VOMITING | 1,326 |
| 8 | PAIN | 1,253 |
| 9 | DRUG INEFFECTIVE | 1,230 |
| 10 | DEATH | 1,187 |
| 11 | PYREXIA | 1,110 |
| 12 | HEADACHE | 1,007 |
| 13 | RASH | 958 |
| 14 | ACUTE KIDNEY INJURY | 957 |
| 15 | COUGH | 933 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not use this medicine if you are allergic to any of its ingredients.
Common Questions
What is nystatin topical powder used for?
How often should I apply the powder?
How long should I use the powder?
Can I use this powder in my mouth?
What should I do if I get a rash after using the powder?
How should I store the powder?
Can I use this powder if I am pregnant?
What should I do if I miss a dose?
Can children use this powder?
What is the strength of nystatin in this powder?
What are the common side effects of nystatin?
What drug class is nystatin?
Is nystatin safe during pregnancy?
Has nystatin been recalled?
Is nystatin currently in shortage?
Active Recalls
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Fagron, Inc
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Fagron, Inc
Related Medications in Polyene Antifungal
Other drugs grouped near nystatin — same-class peers and common alternatives.
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amphotericin B
Ambisome, Fungizone
Amphotericin B liposome is an antifungal medicine.
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anidulafungin
Eraxis
Eraxis is an antifungal medicine.
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atovaquone/proguanil
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Malarone is a drug used to prevent and treat malaria.
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What the FDA Data Shows for nystatin
The FDA label for nystatin (sold under brand names such as Mycostatin) classifies it as a prescription-only medication in the Polyene Antifungal class. This medicine treats skin infections caused by Candida, a type of fungus. Official labeling lists 6 commonly reported side effects, including Allergic reactions, Burning, Itching.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 14,990 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.14.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: July 9, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages