82/100 · Critical
Manufactured by Cosette Pharmaceuticals, Inc.
Nystatin Ointment Adverse Events: High Serious Reaction Rate
56,750 FDA adverse event reports analyzed
Last updated: 2026-05-12
NYSTATIN OINTMENT is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cosette Pharmaceuticals, Inc.. Based on analysis of 56,750 FDA adverse event reports, NYSTATIN OINTMENT has a safety score of 82 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 OINTMENT include NAUSEA, DIARRHOEA, FATIGUE, PNEUMONIA, DYSPNOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NYSTATIN OINTMENT.
Nystatin Ointment has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 56,750 adverse event reports for this medication, which is primarily manufactured by Cosette Pharmaceuticals, Inc..
The most commonly reported adverse events include Nausea, Diarrhoea, Fatigue. Of classified reports, 78.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nystatin ointment reports include a high number of serious reactions, particularly pneumonia and respiratory failure.
The most common reactions are nausea, diarrhea, and fatigue, indicating gastrointestinal and general discomfort. Death reports are notable, with 1105 cases, highlighting the severity of adverse events.
Patients taking Nystatin Ointment should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nystatin ointment has been associated with serious respiratory issues and death, and caution should be exercised, especially in patients with pre-existing respiratory conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nystatin Ointment received a safety concern score of 82/100 (high concern). This is based on a 78.3% serious event ratio across 25,127 classified reports. The score accounts for 56,750 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: 14,391, Male: 8,812, Unknown: 42. The most frequently reported age groups are age 66 (467 reports), age 63 (451 reports), age 67 (449 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 25,127 classified reports for NYSTATIN OINTMENT:
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 ointment has been associated with serious respiratory issues and death, and caution should be exercised, especially in patients with pre-existing respiratory conditions.
If you are taking Nystatin Ointment, here are important things to know. The most commonly reported side effects include nausea, diarrhoea, fatigue, 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 inform their healthcare provider if they experience any serious symptoms, such as respiratory issues or signs of infection. Follow the prescribed usage and dosage instructions carefully to minimize the risk of adverse reactions. 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 is closely monitoring the safety of Nystatin ointment, and healthcare providers should report any adverse events to the agency.
The FDA has received approximately 56,750 adverse event reports associated with Nystatin Ointment. 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 Ointment include Nausea, Diarrhoea, Fatigue, Pneumonia, Dyspnoea. By volume, the top reported reactions are: Nausea (1,885 reports), Diarrhoea (1,713 reports), Fatigue (1,710 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 Ointment.
Out of 25,127 classified reports, 19,668 (78.3%) were classified as serious and 5,459 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 Ointment break down by patient sex as follows: Female: 14,391, Male: 8,812, 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 Ointment adverse events are: age 66: 467 reports, age 63: 451 reports, age 67: 449 reports, age 52: 448 reports, age 62: 430 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 Ointment 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 Ointment 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 Ointment 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 Ointment has a safety concern score of 82 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. Nystatin ointment reports include a high number of serious reactions, particularly pneumonia and respiratory failure.
Key safety signals identified in Nystatin Ointment's adverse event data include: Pneumonia and respiratory failure are significant serious reactions.. Death reports are a key safety signal, with 1105 cases.. A high number of serious reactions (78.3%) indicates a concerning safety profile.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nystatin ointment has been associated with serious respiratory issues and death, and caution should be exercised, especially in patients with pre-existing respiratory conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nystatin Ointment.
Patients should inform their healthcare provider if they experience any serious symptoms, such as respiratory issues or signs of infection. Follow the prescribed usage and dosage instructions carefully to minimize the risk of adverse reactions.
Nystatin Ointment has 56,750 adverse event reports on file with the FDA. The most common reactions are nausea, diarrhea, and fatigue, indicating gastrointestinal and general discomfort. The volume of reports for Nystatin Ointment reflects both the drug's usage level and the vigilance of the reporting community.
The FDA is closely monitoring the safety of Nystatin ointment, and healthcare providers should report any adverse events to the agency. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Cosette Pharmaceuticals, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with NYSTATIN OINTMENT:
Drugs related to NYSTATIN OINTMENT based on therapeutic use, drug class, or shared indications: