85/100 · Critical
Manufactured by Cosette Pharmaceuticals, Inc.
High Safety Concerns with Nystatin Cream, Especially for Older Adults
56,819 FDA adverse event reports analyzed
Last updated: 2026-05-12
NYSTATIN CREAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cosette Pharmaceuticals, Inc.. Based on analysis of 56,819 FDA adverse event reports, NYSTATIN CREAM has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for NYSTATIN CREAM include NAUSEA, FATIGUE, DIARRHOEA, PNEUMONIA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NYSTATIN CREAM.
Nystatin Cream has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 56,819 adverse event reports for this medication, which is primarily manufactured by Cosette Pharmaceuticals, Inc..
The most commonly reported adverse events include Nausea, Fatigue, Diarrhoea. Of classified reports, 78.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including pneumonia, kidney injury, and death, are common.
A wide range of reactions, from nausea to respiratory failure, indicates diverse safety issues. The majority of reports (78.2%) are serious, highlighting significant safety concerns.
Patients taking Nystatin Cream should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nystatin cream may interact with other medications, and its use in unapproved indications is common, potentially leading to adverse drug interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nystatin Cream received a safety concern score of 85/100 (high concern). This is based on a 78.2% serious event ratio across 25,176 classified reports. The score accounts for 56,819 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 14,428, Male: 8,822, Unknown: 42. The most frequently reported age groups are age 66 (468 reports), age 63 (452 reports), age 67 (449 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 25,176 classified reports for NYSTATIN CREAM:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Nystatin cream may interact with other medications, and its use in unapproved indications is common, potentially leading to adverse drug interactions.
If you are taking Nystatin Cream, here are important things to know. The most commonly reported side effects include nausea, fatigue, diarrhoea, pneumonia, dyspnoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any unusual symptoms to their healthcare provider immediately. Avoid using Nystatin cream for unapproved indications unless specifically advised by a healthcare professional. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA should closely monitor this drug due to high serious event rates. Healthcare providers should be cautious when prescribing it, especially to older adults.
The FDA has received approximately 56,819 adverse event reports associated with Nystatin Cream. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Nystatin Cream include Nausea, Fatigue, Diarrhoea, Pneumonia, Dyspnoea. By volume, the top reported reactions are: Nausea (1,887 reports), Fatigue (1,714 reports), Diarrhoea (1,713 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nystatin Cream.
Out of 25,176 classified reports, 19,697 (78.2%) were classified as serious and 5,479 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Nystatin Cream break down by patient sex as follows: Female: 14,428, Male: 8,822, Unknown: 42. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Nystatin Cream adverse events are: age 66: 468 reports, age 63: 452 reports, age 67: 449 reports, age 52: 448 reports, age 62: 431 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Nystatin Cream adverse event reports is Cosette Pharmaceuticals, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Nystatin Cream include: Off Label Use, Vomiting, Pain, Drug Ineffective, Death. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Nystatin Cream to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Nystatin Cream has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Serious adverse events, including pneumonia, kidney injury, and death, are common.
Key safety signals identified in Nystatin Cream's adverse event data include: Multiple reports of severe respiratory issues (pneumonia, respiratory failure).. High incidence of kidney-related issues (renal failure, chronic kidney disease).. Significant number of fatalities reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nystatin cream may interact with other medications, and its use in unapproved indications is common, potentially leading to adverse drug interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nystatin Cream.
Patients should report any unusual symptoms to their healthcare provider immediately. Avoid using Nystatin cream for unapproved indications unless specifically advised by a healthcare professional.
Nystatin Cream has 56,819 adverse event reports on file with the FDA. A wide range of reactions, from nausea to respiratory failure, indicates diverse safety issues. The volume of reports for Nystatin Cream reflects both the drug's usage level and the vigilance of the reporting community.
The FDA should closely monitor this drug due to high serious event rates. Healthcare providers should be cautious when prescribing it, especially to older adults. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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