85/100 · Critical
Manufactured by Allegis Holdings LLC
Hydrocortisone Lotion Adverse Events: High Seriousness and Diverse Reactions
229,207 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCORTISONE LOTION is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allegis Holdings LLC. Based on analysis of 229,207 FDA adverse event reports, HYDROCORTISONE LOTION 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 LOTION 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 LOTION.
Hydrocortisone Lotion 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 229,207 adverse event reports for this medication, which is primarily manufactured by Allegis Holdings Llc.
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.
Diverse range of reactions, including systemic and gastrointestinal issues, suggests broad potential risks. Report volume is substantial, with over 229,000 reports, providing a comprehensive dataset for analysis.
Patients taking Hydrocortisone Lotion should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocortisone lotion can cause serious systemic reactions and should be used with caution, especially in patients with pre-existing conditions. Warnings include potential for exacerbation of underlying conditions and serious infections. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrocortisone Lotion received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,590 classified reports. The score accounts for 229,207 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: 32,034, Male: 23,634, Unknown: 130. The most frequently reported age groups are age 43 (1,429 reports), age 44 (1,197 reports), age 40 (1,043 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 63,590 classified reports for HYDROCORTISONE LOTION:
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 lotion can cause serious systemic reactions and should be used with caution, especially in patients with pre-existing conditions. Warnings include potential for exacerbation of underlying conditions and serious infections.
If you are taking Hydrocortisone Lotion, 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 potential serious side effects. Report any adverse reactions to the FDA's MedWatch program for ongoing safety surveillance. 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 lotion, and healthcare providers should be vigilant in managing patient risks and reporting adverse events.
The FDA has received approximately 229,207 adverse event reports associated with Hydrocortisone Lotion. 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 Lotion include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Nausea. By volume, the top reported reactions are: Off Label Use (8,924 reports), Drug Ineffective (7,048 reports), Fatigue (5,579 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 Lotion.
Out of 63,590 classified reports, 53,046 (83.4%) were classified as serious and 10,544 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 Lotion break down by patient sex as follows: Female: 32,034, Male: 23,634, 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 Lotion adverse events are: age 43: 1,429 reports, age 44: 1,197 reports, age 40: 1,043 reports, age 60: 838 reports, age 65: 838 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 Lotion adverse event reports is Allegis Holdings 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 Hydrocortisone Lotion 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 Lotion 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 Lotion 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 Lotion's adverse event data include: High number of serious reactions (53,046) out of total reports (63,590).. Diverse reactions include systemic effects like pneumonia and liver enzyme increases, as well as local skin reactions.. Multiple reports of drug ineffectiveness and off-label use suggest potential misuse or inefficacy issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocortisone lotion can cause serious systemic reactions and should be used with caution, especially in patients with pre-existing conditions. Warnings include potential for exacerbation of underlying conditions and serious infections. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrocortisone Lotion.
Follow prescribed usage guidelines strictly to avoid potential serious side effects. Report any adverse reactions to the FDA's MedWatch program for ongoing safety surveillance.
Hydrocortisone Lotion has 229,207 adverse event reports on file with the FDA. Diverse range of reactions, including systemic and gastrointestinal issues, suggests broad potential risks. The volume of reports for Hydrocortisone Lotion reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hydrocortisone lotion, and healthcare providers should be vigilant in managing patient risks and reporting adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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