85/100 · Critical
Manufactured by Target Corporation
Hydrocortisone 1% Adverse Events Show High Serious Reaction Rate
229,310 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCORTISONE 1% is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Target Corporation. Based on analysis of 229,310 FDA adverse event reports, HYDROCORTISONE 1% 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 1% include OFF LABEL USE, DRUG INEFFECTIVE, FATIGUE, CONDITION AGGRAVATED, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROCORTISONE 1%.
Hydrocortisone 1% 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 229,310 adverse event reports for this medication, which is primarily manufactured by Target Corporation.
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. High percentage of serious adverse events (83.4%) indicates significant safety concerns.
A wide range of reactions reported, including serious conditions like pneumonia and death. Report volume is substantial, with over 229,000 reports, providing a comprehensive dataset.
Patients taking Hydrocortisone 1% should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocortisone 1% can cause serious adverse events, and its use should be strictly monitored, 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.
Hydrocortisone 1% received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,656 classified reports. The score accounts for 229,310 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: 32,068, Male: 23,665, Unknown: 130. The most frequently reported age groups are age 43 (1,430 reports), age 44 (1,197 reports), age 40 (1,044 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,656 classified reports for HYDROCORTISONE 1%:
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 1% can cause serious adverse events, and its use should be strictly monitored, especially in patients with pre-existing respiratory conditions.
If you are taking Hydrocortisone 1%, here are important things to know. The most commonly reported side effects include off label use, drug ineffective, fatigue, condition aggravated, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Follow prescribed usage guidelines strictly to avoid misuse and potential serious adverse events. Report any unusual symptoms or side effects to healthcare providers promptly. 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 1% and may require additional safety studies or label changes based on ongoing data.
The FDA has received approximately 229,310 adverse event reports associated with Hydrocortisone 1%. 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 1% include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Nausea. By volume, the top reported reactions are: Off Label Use (8,925 reports), Drug Ineffective (7,056 reports), Fatigue (5,584 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 1%.
Out of 63,656 classified reports, 53,091 (83.4%) were classified as serious and 10,565 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 1% break down by patient sex as follows: Female: 32,068, Male: 23,665, Unknown: 130. 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 1% adverse events are: age 43: 1,430 reports, age 44: 1,197 reports, age 40: 1,044 reports, age 60: 840 reports, age 65: 839 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 1% adverse event reports is Target Corporation. 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 1% include: Rash, Pain, Headache, Diarrhoea, Arthralgia. 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 1% 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 1% 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. High percentage of serious adverse events (83.4%) indicates significant safety concerns.
Key safety signals identified in Hydrocortisone 1%'s adverse event data include: Pneumonia and other respiratory issues are frequently reported, suggesting potential respiratory risks.. Death and serious infections are among the most severe reactions reported.. Intentional product use issues and off-label use are common, indicating misuse or abuse.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocortisone 1% can cause serious adverse events, and its use should be strictly monitored, 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 Hydrocortisone 1%.
Follow prescribed usage guidelines strictly to avoid misuse and potential serious adverse events. Report any unusual symptoms or side effects to healthcare providers promptly.
Hydrocortisone 1% has 229,310 adverse event reports on file with the FDA. A wide range of reactions reported, including serious conditions like pneumonia and death. The volume of reports for Hydrocortisone 1% reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hydrocortisone 1% and may require additional safety studies or label changes based on ongoing data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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