Hydrocortisone acetate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Hydrocortisone acetate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Corticosteroid
Also reported as: Hydrocortisone Acetate Cream Usp

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From March 2004 to June 2026, FDA received 3,564 adverse event reports that name Hydrocortisone acetate. In these reports the drug is a suspect or interacting product.

In the same period, 1,802 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 372 reports in the 12 months to June 2026 and 500 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Hydrocortisone acetate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 72 reports that name Hydrocortisone acetate.
In January to March 2026, FDA received 70.
In April to June 2025, FDA received 73.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 439 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 3,500 of the 3,564 reports (98.2%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 439 terms.

Reaction terms in the reports that name Hydrocortisone acetate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,564 reports
Drug ineffectivethe medicine did not work as expected	1,851	51.9%
Abdominal discomfortstomach discomfort	1,783	50%
Systemic lupus erythematosuslupus, an autoimmune disease	1,778	49.9%
Painpain, site not specified	1,729	48.5%
Alopeciahair loss	1,718	48.2%
Fatiguetiredness	1,714	48.1%
Rashskin rash	1,682	47.2%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	1,667	46.8%
Pemphigus	1,666	46.7%
Glossodynia	1,653	46.4%
Swelling	1,642	46.1%
Hand deformity	1,621	45.5%
Hepatic enzyme increasedraised liver enzymes	1,612	45.2%
Infusion related reactiona reaction during or soon after an infusion	1,604	45%
Wound	1,598	44.8%
Pericarditisinflammation of the sac around the heart	1,596	44.8%
Arthropathy	1,589	44.6%
Synovitis	1,549	43.5%
Hypersensitivityan allergic-type reaction	1,502	42.1%
Drug intolerancethe medicine was not tolerated	1,495	41.9%
Discomfort	1,479	41.5%
Joint swellinga swollen joint	1,454	40.8%
Anti-cyclic citrullinated peptide antibody positive	1,439	40.4%
Condition aggravatedthe condition being treated got worse	1,434	40.2%
Off label useused for a purpose or in a way not on the label	1,370	38.4%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	1,320	37%
Duodenal ulcer perforation	1,290	36.2%
Helicobacter infection	1,275	35.8%
Contraindicated product administered	1,245	34.9%
Arthralgiajoint pain	1,202	33.7%
General physical health deteriorationgeneral decline in health	1,183	33.2%
Rheumatoid factor positive	1,182	33.2%
Blistera blister	1,162	32.6%
Treatment failurethe treatment did not work	1,100	30.9%
Product use issuea problem in how the product was used	1,097	30.8%
Musculoskeletal stiffnessstiffness in muscles or joints	992	27.8%
Hypertensionhigh blood pressure	978	27.4%
Blood cholesterol increasedraised cholesterol	974	27.3%
Confusional stateconfusion	974	27.3%
Type 2 diabetes mellitustype 2 diabetes	967	27.1%
Headachehead pain	966	27.1%
Dyspnoeashortness of breath	949	26.6%
Therapeutic product effect decreased	923	25.9%
Intentional product use issuedeliberate use not as intended	900	25.3%
Impaired healingslow healing	892	25%
Rheumatic fever	887	24.9%
Folliculitis	882	24.7%
Injurya physical injury	873	24.5%
Vomitingbeing sick	863	24.2%
Infectionan infection, type not specified	859	24.1%

Download all 439 terms of Hydrocortisone acetate (CSV)

The counts add to more than 3,564 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Hydrocortisone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Hydrocortisone	Generic name	21,263
Hydrocortisone acetate (this page)	Generic name	3,564
Hydrocortisone sodium succinate	Generic name	2,343
Alkindi Sprinkle	Brand name	313
Cortef	Brand name	588
Cortifoam	Brand name	321
Cortisone	Brand name	6,186
Diprospan	Brand name	345

Sum of the separately reported names: 34,923. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Hydrocortisone acetate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	2	2	0	1	1	0	0	1	0
2005	6	6	2	0	3	1	0	5	0
2006	19	19	3	3	11	5	0	8	0
2007	9	9	1	0	4	1	0	7	0
2008	9	6	0	2	1	0	0	3	3
2009	4	4	1	1	3	0	0	3	0
2010	5	5	1	1	1	0	0	5	0
2011	12	10	1	0	4	0	0	7	2
2012	8	3	0	0	1	0	0	3	5
2013	9	5	0	0	2	0	0	5	4
2014	13	10	3	0	4	0	3	5	3
2015	10	4	1	0	2	0	0	3	6
2016	18	11	0	0	5	1	0	10	7
2017	21	14	0	0	5	0	0	14	7
2018	32	10	0	0	3	1	0	9	22
2019	63	34	5	3	5	2	0	27	29
2020	107	89	2	12	16	14	1	78	18
2021	437	408	8	46	45	168	3	381	29
2022	597	553	65	189	199	314	10	487	44
2023	523	479	176	235	285	314	43	442	44
2024	653	637	363	383	439	413	125	614	16
2025	665	655	442	478	499	489	184	616	10
2026	342	339	278	269	286	270	158	324	3

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Hydrocortisone acetate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Hydrocortisone acetate, by the year in which FDA received them
Year	Reports
2004	2
2005	6
2006	19
2007	8
2008	7
2009	6
2010	6
2011	12
2012	13
2013	5
2014	13
2015	22
2016	26
2017	30
2018	49
2019	105
2020	200
2021	594
2022	618
2023	580
2024	660
2025	441
2026	142

Reports that name Hydrocortisone acetate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Hydrocortisone acetate
Age	Reports	Share
Under 2	13	0.4%
2 to 11	52	1.5%
12 to 17	23	0.6%
18 to 44	1,654	46.4%
45 to 64	458	12.9%
65 to 74	59	1.7%
75 and over	175	4.9%
Age not given	1,130	31.7%

Sex of the patient in the reports that name Hydrocortisone acetate
Sex	Reports	Share
Female	2,564	71.9%
Male	435	12.2%
Unknown or not given	565	15.9%

Type of reporter in the reports that name Hydrocortisone acetate
Reporter	Reports	Share
Physician	707	19.8%
Pharmacist	24	0.7%
Other health professional	2,336	65.5%
Lawyer	3	0.1%
Consumer or non-health professional	481	13.5%
Not given	13	0.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 10.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Hydrocortisone acetate record
Indication as recorded (MedDRA)	Reports	Share
Rheumatoid arthritis	1,653	46.4%
Colitis ulcerative	79	2.2%
Eczema	32	0.9%
Adverse event	26	0.7%
Psoriasis	23	0.6%
Crohn's disease	20	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,564 reports.

Drugs in the same reports

Other drugs that the reports of Hydrocortisone acetate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	2,396
Cimzia	2,222
Desoximetasone	2,453
Folic acid	2,534
Humira	2,220
Methotrexate	2,502
Orencia	2,249
Prednisone	2,651
Rituximab	2,181
Sulfasalazine	2,494

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Hydrocortisone same ingredient
Hydrocortisone sodium succinate same ingredient
Alkindi Sprinkle same ingredient
Cortef same ingredient
Cortifoam same ingredient
Cortisone same ingredient
Hydrocortisone butyrate same class
Halobetasol propionate same class
Fml same class
Iluvien same class
Hydrocodone/Acetaminophen next in the A to Z list
Hydrocortisone Probutate next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Hydrocortisone acetateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Hydrocortisone acetate: adverse event reports that FDA received. https://reportedreactions.com/drug/hydrocortisone-acetate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Hydrocortisone acetate as a suspect or interacting product. The 1,802 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Hydrocortisone acetate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Hydrocortisone acetate?

No. It is a count of what people reported to FDA: 3,564 reports from March 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (65.5%), physician (19.8%) and consumer or non-health professional (13.5%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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