85/100 · Critical
Manufactured by Sun Pharmaceutical Industries, Inc.
Hydrocortisone Acetate Adverse Events: High Seriousness and Diverse Reactions
298,939 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCORTISONE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Sun Pharmaceutical Industries, Inc.. Based on analysis of 298,939 FDA adverse event reports, HYDROCORTISONE ACETATE 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 HYDROCORTISONE ACETATE include OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, CONDITION AGGRAVATED, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCORTISONE ACETATE.
Hydrocortisone Acetate 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 298,939 adverse event reports for this medication, which is primarily manufactured by Sun Pharmaceutical Industries, Inc..
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Fatigue. Of classified reports, 83.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Hydrocortisone Acetate reports show a high percentage of serious adverse events (83.4%).
The most common reactions include fatigue, rash, and pain, indicating a broad range of potential side effects. Reports indicate a significant number of serious conditions such as pneumonia, systemic lupus erythematosus, and pericarditis.
Patients taking Hydrocortisone Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocortisone Acetate can cause serious conditions like pneumonia and systemic lupus erythematosus, and should be used with caution, especially in patients with pre-existing respiratory or gastrointestinal issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrocortisone Acetate received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 69,002 classified reports. The score accounts for 298,939 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: 35,397, Male: 25,090, Unknown: 136. The most frequently reported age groups are age 43 (1,913 reports), age 44 (1,608 reports), age 40 (1,166 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 69,002 classified reports for HYDROCORTISONE 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.
Hydrocortisone Acetate can cause serious conditions like pneumonia and systemic lupus erythematosus, and should be used with caution, especially in patients with pre-existing respiratory or gastrointestinal issues.
If you are taking Hydrocortisone Acetate, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, fatigue, condition aggravated, rash. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed dosage and duration of use strictly to minimize the risk of adverse events. Report any unusual symptoms to your healthcare provider immediately. 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 Hydrocortisone Acetate, and updates will be provided as new data becomes available.
The FDA has received approximately 298,939 adverse event reports associated with Hydrocortisone 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 Hydrocortisone Acetate include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Rash. By volume, the top reported reactions are: Off Label Use (10,132 reports), Drug Ineffective (8,687 reports), Fatigue (7,069 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Hydrocortisone Acetate.
Out of 69,002 classified reports, 57,569 (83.4%) were classified as serious and 11,433 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 Hydrocortisone Acetate break down by patient sex as follows: Female: 35,397, Male: 25,090, Unknown: 136. 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 Hydrocortisone Acetate adverse events are: age 43: 1,913 reports, age 44: 1,608 reports, age 40: 1,166 reports, age 60: 907 reports, age 59: 896 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 Hydrocortisone Acetate adverse event reports is Sun Pharmaceutical Industries, 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 Hydrocortisone Acetate include: Pain, Nausea, Arthralgia, Diarrhoea, Headache. 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 Hydrocortisone 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.
Hydrocortisone Acetate 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. Hydrocortisone Acetate reports show a high percentage of serious adverse events (83.4%).
Key safety signals identified in Hydrocortisone Acetate's adverse event data include: High percentage of serious adverse events (83.4%). Diverse range of reactions including systemic lupus erythematosus and pericarditis. Significant number of reports involving respiratory and gastrointestinal issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocortisone Acetate can cause serious conditions like pneumonia and systemic lupus erythematosus, and should be used with caution, especially in patients with pre-existing respiratory or gastrointestinal issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrocortisone Acetate.
Follow prescribed dosage and duration of use strictly to minimize the risk of adverse events. Report any unusual symptoms to your healthcare provider immediately.
Hydrocortisone Acetate has 298,939 adverse event reports on file with the FDA. The most common reactions include fatigue, rash, and pain, indicating a broad range of potential side effects. The volume of reports for Hydrocortisone Acetate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Hydrocortisone Acetate, and updates will be provided as new data becomes available. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Sun Pharmaceutical Industries, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with HYDROCORTISONE ACETATE:
Drugs related to HYDROCORTISONE ACETATE based on therapeutic use, drug class, or shared indications: