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nystatin

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Brand names: Mycostatin

Polyene Antifungal Rx

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.

Feeling sick to your stomach
1,958
Feeling very tired
1,795
Loose, watery stools
1,781
Lung infection
1,612
Difficulty breathing
1,478
Using the medicine for a condition it is not approved for
1,376
Throwing up
1,323
Discomfort or aching
1,252
Medicine not working
1,228
The end of life
1,187

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

Female 15,167 (62%)
Male 9,079 (37%)

Age Distribution

0–17 1,344
18–44 2,403
45–64 6,622
65–74 4,385
75+ 3,109

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

DEATH 1,181
PNEUMONIA 353
SEPSIS 294
RESPIRATORY FAILURE 233
DYSPNOEA 229
RENAL FAILURE 209
NAUSEA 185
ASTHENIA 182
DIARRHOEA 182
OFF LABEL USE 181

Reactions in Hospitalization Reports

PNEUMONIA 1,367
NAUSEA 1,097
DIARRHOEA 945
VOMITING 921
DYSPNOEA 895
PYREXIA 803
FATIGUE 780
URINARY TRACT INFECTION 634
OFF LABEL USE 589
PAIN 587

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?
It is used to treat fungal infections of the skin.
How often should I apply the powder?
Apply it two or three times a day.
How long should I use the powder?
Keep using it until the infection is completely gone.
Can I use this powder in my mouth?
No, this powder is for skin use only.
What should I do if I get a rash after using the powder?
Stop using the powder and talk to your doctor.
How should I store the powder?
Store it at room temperature, away from heat and moisture.
Can I use this powder if I am pregnant?
Talk to your doctor before using it if you are pregnant.
What should I do if I miss a dose?
Apply it as soon as you remember.
Can children use this powder?
Yes, children can use this powder.
What is the strength of nystatin in this powder?
It contains 100,000 units of nystatin per gram.
What are the common side effects of nystatin?
The most commonly reported side effects of nystatin include Allergic reactions, Burning, Itching, Rash, Eczema. Based on 14,990 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is nystatin?
nystatin belongs to the Polyene Antifungal drug class. It requires a prescription (Rx). This medicine treats skin infections caused by Candida, a type of fungus.
Is nystatin safe during pregnancy?
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. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has nystatin been recalled?
There are 2 recalls associated with nystatin products. Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. Check the recalls section below for full details and affected products.
Is nystatin currently in shortage?
Yes, nystatin is currently listed as to be discontinued by the FDA. Affected manufacturer: Upsher-Smith Laboratories, LLC. Visit the FDA Drug Shortages database for the latest updates.

Active Recalls

Class II December 11, 2023

Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.

Fagron, Inc

Class II December 11, 2023

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 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

All federal data sources used on this page