85/100 · Critical
Manufactured by A2A Integrated Pharmaceuticals, LLC
Hydrocortisone Spray Adverse Events: High Seriousness and Diverse Reactions
229,196 FDA adverse event reports analyzed
Last updated: 2026-05-12
HYDROCORTISONE SPRAY is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by A2A Integrated Pharmaceuticals, LLC. Based on analysis of 229,196 FDA adverse event reports, HYDROCORTISONE SPRAY 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 SPRAY 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 SPRAY.
Hydrocortisone Spray 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 229,196 adverse event reports for this medication, which is primarily manufactured by A2a Integrated Pharmaceuticals, 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. 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 indicate potential for significant respiratory and gastrointestinal issues. The drug is frequently reported to be ineffective or to cause conditions to worsen. There are notable reports of weight changes and musculoskeletal issues.
Patients taking Hydrocortisone Spray should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Hydrocortisone spray may interact with other corticosteroids and should not be used in patients with known hypersensitivity to the drug. It is contraindicated in patients with certain infections and should be used with caution in patients with a hist This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Hydrocortisone Spray received a safety concern score of 85/100 (high concern). This is based on a 83.4% serious event ratio across 63,581 classified reports. The score accounts for 229,196 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: 32,032, Male: 23,627, 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 63,581 classified reports for HYDROCORTISONE SPRAY:
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 spray may interact with other corticosteroids and should not be used in patients with known hypersensitivity to the drug. It is contraindicated in patients with certain infections and should be used with caution in patients with a hist
If you are taking Hydrocortisone Spray, 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 instructions carefully to avoid misuse and potential serious side effects. Report any unusual symptoms or worsening of existing conditions 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 spray and has not issued any specific warnings or recalls. However, healthcare providers should be vigilant about the potential for serious adverse events and should monitor patients closely.
The FDA has received approximately 229,196 adverse event reports associated with Hydrocortisone Spray. 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 Spray include Off Label Use, Drug Ineffective, Fatigue, Condition Aggravated, Nausea. By volume, the top reported reactions are: Off Label Use (8,923 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 Spray.
Out of 63,581 classified reports, 53,039 (83.4%) were classified as serious and 10,542 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 Spray break down by patient sex as follows: Female: 32,032, Male: 23,627, 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 Spray 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 Spray adverse event reports is A2a Integrated Pharmaceuticals, 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 Spray 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 Spray 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 Spray 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 Spray's adverse event data include: High percentage of serious adverse events (83.4%). Diverse reactions including systemic lupus erythematosus, pneumonia, and systemic health deterioration. Frequent reports of gastrointestinal issues like diarrhea and abdominal pain. Significant number of reports involving respiratory issues such as dyspnea and wheezing. Reports of weight changes and musculoskeletal stiffness. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Hydrocortisone spray may interact with other corticosteroids and should not be used in patients with known hypersensitivity to the drug. It is contraindicated in patients with certain infections and should be used with caution in patients with a hist Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Hydrocortisone Spray.
Follow prescribed usage instructions carefully to avoid misuse and potential serious side effects. Report any unusual symptoms or worsening of existing conditions to your healthcare provider immediately.
Hydrocortisone Spray has 229,196 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 Spray reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of hydrocortisone spray and has not issued any specific warnings or recalls. However, healthcare providers should be vigilant about the potential for serious adverse events and should monitor patients closely. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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