85/100 · Critical
Manufactured by CVS Pharmacy
Hydrocortisone Cream Adverse Events: High Seriousness and Diverse Reactions
229,712 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCORTISONE CREAM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS Pharmacy. Based on analysis of 229,712 FDA adverse event reports, HYDROCORTISONE 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 HYDROCORTISONE CREAM 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 CREAM.
Hydrocortisone 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 229,712 adverse event reports for this medication, which is primarily manufactured by Cvs Pharmacy.
The most commonly reported adverse events include Off Label Use, Drug Ineffective, Fatigue. Of classified reports, 83.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving systemic effects and infections.
A wide range of reactions are reported, indicating diverse safety concerns. Reports of fatalities and severe conditions like pneumonia and systemic lupus erythematosus are notable. The drug is frequently reported to be ineffective, suggesting potential issues with its efficacy. There are significant reports of weight changes and gastrointestinal issues, which could be related to prolonged use.
Patients taking Hydrocortisone Cream should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocortisone cream can cause systemic effects and infections, and should be used with caution, especially in patients with pre-existing conditions. It is important to follow the prescribed treatment plan and avoid off-label use. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrocortisone Cream received a safety concern score of 85/100 (high concern). This is based on a 83.3% serious event ratio across 63,925 classified reports. The score accounts for 229,712 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: 32,248, Male: 23,746, Unknown: 132. The most frequently reported age groups are age 43 (1,432 reports), age 44 (1,203 reports), age 40 (1,046 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,925 classified reports for HYDROCORTISONE 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.
Hydrocortisone cream can cause systemic effects and infections, and should be used with caution, especially in patients with pre-existing conditions. It is important to follow the prescribed treatment plan and avoid off-label use.
If you are taking Hydrocortisone Cream, 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 the prescribed treatment plan and avoid using the cream for off-label purposes. Monitor for any signs of systemic effects or infections and report them 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 cream, and updates will be provided based on new data. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 229,712 adverse event reports associated with Hydrocortisone 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 Hydrocortisone Cream include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Nausea. By volume, the top reported reactions are: Off Label Use (8,931 reports), Drug Ineffective (7,070 reports), Fatigue (5,595 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 Cream.
Out of 63,925 classified reports, 53,272 (83.3%) were classified as serious and 10,653 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 Cream break down by patient sex as follows: Female: 32,248, Male: 23,746, Unknown: 132. 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 Cream adverse events are: age 43: 1,432 reports, age 44: 1,203 reports, age 40: 1,046 reports, age 60: 843 reports, age 65: 842 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 Cream adverse event reports is Cvs Pharmacy. 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 Cream include: Rash, Pain, Diarrhoea, Headache, 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 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.
Hydrocortisone 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. The majority of adverse events are serious, with a high percentage of reports involving systemic effects and infections.
Key safety signals identified in Hydrocortisone Cream's adverse event data include: High number of serious adverse events (53,272 out of 63,925 total, 83.3%). Diverse reactions including systemic lupus erythematosus, pneumonia, and weight changes. Reports of fatalities and severe conditions like pericarditis and duodenal ulcer perforation. Frequent reports of drug ineffectiveness and off-label use. Multiple reports of gastrointestinal issues and infections. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocortisone cream can cause systemic effects and infections, and should be used with caution, especially in patients with pre-existing conditions. It is important to follow the prescribed treatment plan and avoid off-label use. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrocortisone Cream.
Follow the prescribed treatment plan and avoid using the cream for off-label purposes. Monitor for any signs of systemic effects or infections and report them to your healthcare provider immediately.
Hydrocortisone Cream has 229,712 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Hydrocortisone Cream reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hydrocortisone cream, and updates will be provided based on new data. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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