Prescription medication · Polyene Antifungal
nystatin
Also sold as Mycostatin. This medicine treats skin infections caused by Candida, a type of fungus.
Data updated 2026-05-15
- 26,244
- FDA reportsModerately reported
- In shortage
- FDA status
What the data shows
nystatin (Mycostatin) is a prescription Polyene Antifungal, reported at a middle-of-the-pack volume (26,244 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
nystatin (Mycostatin) is a prescription Polyene Antifungal. This medicine treats skin infections caused by Candida, a type of fungus.
Nystatin topical powder is an antifungal medicine. It treats fungal infections on your skin.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from nystatin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of nystatin's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of nystatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Apply the missed dose as soon as you remember. Then, continue with your regular schedule.
This is a plain-language summary of nystatin's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 26,244 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for nystatin, by number of reports
- Feeling sick to your stomach
Feeling sick to your stomach
1,958 reports
- Feeling very tired
Feeling very tired
1,795 reports
- Loose, watery stools
Loose, watery stools
1,781 reports
- Lung infection
Lung infection
1,612 reports
- Difficulty breathing
Difficulty breathing
1,478 reports
- Throwing up
Throwing up
1,323 reports
- Discomfort or aching
Discomfort or aching
1,252 reports
- The end of life
The end of life
1,187 reports
- Fever
Fever
1,110 reports
- Pain in your head
Pain in your head
1,005 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for nystatin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where nystatin sits
nystatin has more FDA adverse-event reports than 61% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is nystatin; the line is the median (50th percentile).
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
Reports Mentioning Death
3,637
13.9% of reports — not proof of cause
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 |
| 7 | VOMITING | 1,326 |
| 8 | PAIN | 1,253 |
| 10 | DEATH | 1,187 |
| 11 | PYREXIA | 1,110 |
| 12 | HEADACHE | 1,007 |
| 13 | RASH | 958 |
| 14 | ACUTE KIDNEY INJURY | 957 |
| 15 | COUGH | 933 |
| 16 | ASTHENIA | 932 |
| 17 | CHRONIC KIDNEY DISEASE | 889 |
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
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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 26,244 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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