65/100 · Elevated
Manufactured by Amneal Pharmaceuticals NY LLC
Fludrocortisone Acetate Adverse Events: Common Mild Reactions with Some Serious Cases
4,832 FDA adverse event reports analyzed
Last updated: 2026-05-12
FLUDROCORTISONE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals NY LLC. Based on analysis of 4,832 FDA adverse event reports, FLUDROCORTISONE ACETATE has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for FLUDROCORTISONE ACETATE include FATIGUE, FALL, DIZZINESS, NAUSEA, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FLUDROCORTISONE ACETATE.
Fludrocortisone Acetate has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 4,832 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Ny Llc.
The most commonly reported adverse events include Fatigue, Fall, Dizziness. Of classified reports, 72.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue, falls, and dizziness are the most common reactions, often mild to moderate in severity.
Serious adverse events such as death, pneumonia, and sepsis are reported but less frequent. Drug interactions and off-label use are noted as key safety signals. The majority of reactions are non-serious, but the presence of serious events warrants caution.
Patients taking Fludrocortisone Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Fludrocortisone Acetate can cause falls and dizziness, which may increase the risk of injury. It is important to monitor patients for these symptoms, especially the elderly. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Fludrocortisone Acetate received a safety concern score of 65/100 (elevated concern). This is based on a 72.0% serious event ratio across 2,085 classified reports. The score accounts for 4,832 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 1,003, Male: 936, Unknown: 3. The most frequently reported age groups are age 72 (44 reports), age 74 (41 reports), age 68 (40 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 2,085 classified reports for FLUDROCORTISONE ACETATE:
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.
Fludrocortisone Acetate can cause falls and dizziness, which may increase the risk of injury. It is important to monitor patients for these symptoms, especially the elderly.
If you are taking Fludrocortisone Acetate, here are important things to know. The most commonly reported side effects include fatigue, fall, dizziness, nausea, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of falls and dizziness, especially those with pre-existing conditions or the elderly. Ensure proper dosing and avoid off-label use to reduce the risk of adverse events. 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 continues to monitor the safety of Fludrocortisone Acetate, and updates will be provided as necessary. Patients should report any adverse reactions to their healthcare provider.
The FDA has received approximately 4,832 adverse event reports associated with Fludrocortisone Acetate. 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 Fludrocortisone Acetate include Fatigue, Fall, Dizziness, Nausea, Death. By volume, the top reported reactions are: Fatigue (146 reports), Fall (144 reports), Dizziness (135 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Fludrocortisone Acetate.
Out of 2,085 classified reports, 1,502 (72.0%) were classified as serious and 583 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 Fludrocortisone Acetate break down by patient sex as follows: Female: 1,003, Male: 936, Unknown: 3. 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 Fludrocortisone Acetate adverse events are: age 72: 44 reports, age 74: 41 reports, age 68: 40 reports, age 65: 37 reports, age 71: 37 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 Fludrocortisone Acetate adverse event reports is Amneal Pharmaceuticals Ny Llc. 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 Fludrocortisone Acetate include: Diarrhoea, Headache, Off Label Use, Pneumonia, Hypotension. 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 Fludrocortisone Acetate 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.
Fludrocortisone Acetate has a safety concern score of 65 out of 100 (elevated 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. Fatigue, falls, and dizziness are the most common reactions, often mild to moderate in severity.
Key safety signals identified in Fludrocortisone Acetate's adverse event data include: Frequent reports of falls and dizziness suggest a risk of falls and balance issues.. Death and pneumonia are serious adverse events that occur in a significant number of reports.. Off-label use and drug interactions are common, indicating potential misuse and interaction risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Fludrocortisone Acetate can cause falls and dizziness, which may increase the risk of injury. It is important to monitor patients for these symptoms, especially the elderly. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Fludrocortisone Acetate.
Monitor patients for signs of falls and dizziness, especially those with pre-existing conditions or the elderly. Ensure proper dosing and avoid off-label use to reduce the risk of adverse events.
Fludrocortisone Acetate has 4,832 adverse event reports on file with the FDA. Serious adverse events such as death, pneumonia, and sepsis are reported but less frequent. The volume of reports for Fludrocortisone Acetate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Fludrocortisone Acetate, and updates will be provided as necessary. Patients should report any adverse reactions to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Amneal Pharmaceuticals NY LLC and compare their safety profiles:
The following drugs share commonly reported adverse reactions with FLUDROCORTISONE ACETATE:
Drugs related to FLUDROCORTISONE ACETATE based on therapeutic use, drug class, or shared indications: