Pet Drug Reports

Hydrocortisone + Ketoconazoleadverse event reports that FDA received

Combination of 2 active ingredients

The Green Book lists no brand name for exactly these active ingredients.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

Read this first. FDA says this about the data:

An API dataset query result cannot be used to estimate the risk associated with the product or compare one drug or device product with another. When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event. This dataset should not be the sole source of information for clinical decision-making or other assumptions about the safety or effectiveness of a product. The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine publishes these words. Source: Adverse Event Reports for Animal Drugs and Devices, read on . The data have the reports that FDA received through .

This page is not veterinary advice. For an animal that is ill, speak to a veterinarian.

Contacting a veterinarianHow to report to FDA

From March 2012 to May 2026, FDA received 85 adverse event reports that name a drug with hydrocortisone and ketoconazole as its active ingredients. Of the 85 reports, 79 (92.9%) are about dogs. 6 reports are about cats (7.1%).

In January to March 2026, FDA received 2 reports that name this drug. The signs that appear in the largest number of the 85 reports are "Lack of efficacy - NOS" and "Loss of hearing". A report is not proof that a drug caused a sign.

Fewer than 20 reports named this drug in the 12 months before June 2026, so this page gives no change. Reports about dogs are 92.9% of the reports that name this drug, and 72.6% of all reports.

Search engines list a drug page with 500 reports or more in all years. The page also needs 30 reports or more in the 12 months to June 2026. This page is under one of these numbers. The site keeps the page and keeps it out of search engines.

Since the last update of the FDA data

The latest update of the FDA data, recorded on , changed no count of this page.

January to March 2026 is the latest closed quarter in the data. In that quarter FDA received 2 reports that name hydrocortisone + ketoconazole: 2 dog, 0 cat, 0 horse, 0 other or not given.

All updatesFeed of updates (RSS)

Signs that the reports list

A sign is a coded term from the report. The words in brackets are a plain gloss of the term. The percentage is the share of the 85 reports that list the sign. One report can list more than one sign.

The sign that is in the largest number of the reports comes first.

  1. Lack of efficacy - NOS[the product did not have the expected effect]18.8%16 reports
  2. Loss of hearing15.3%13 reports
  3. Ataxia[unsteady, uncoordinated movement]11.8%10 reports
  4. Ear discharge11.8%10 reports
  5. Ocular discharge11.8%10 reports
  6. Deafness9.4%8 reports
  7. Ear infection NOS[NOS: not otherwise specified]9.4%8 reports
  8. Anorexia[not eating]8.2%7 reports
  9. Behavioural disorder NOS[behaviour change, type not specified]8.2%7 reports
  10. Erythema (for urticaria see Immune SOC)8.2%7 reports
  11. Head shake - ear disorder8.2%7 reports
  12. Lethargy[unusually tired or inactive]8.2%7 reports
  13. Nystagmus[rapid involuntary eye movement]8.2%7 reports
  14. Pain NOS[NOS: not otherwise specified]8.2%7 reports
Show the next 16 signs
  1. Ear canal disorder7.1%6 reports
  2. Facial paralysis7.1%6 reports
  3. Head tilt - ear disorder7.1%6 reports
  4. Vocalisation[crying out or unusual noise]7.1%6 reports
  5. Vomiting7.1%6 reports
  6. Anisocoria5.9%5 reports
  7. Corneal ulcer5.9%5 reports
  8. Cough5.9%5 reports
  9. Crust5.9%5 reports
  10. Diarrhoea[diarrhea]5.9%5 reports
  11. Eye disorder NOS (for Photophobia see neurological)5.9%5 reports
  12. Nasal dryness5.9%5 reports
  13. Vestibular disorder NOS[NOS: not otherwise specified]5.9%5 reports
  14. Closed eyelid4.7%4 reports
  15. Dry eye4.7%4 reports
  16. Ear canal erythema4.7%4 reports

The list shows 30 of 285 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

The share is of all 85 reports that name hydrocortisone + ketoconazole. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog48 reports

No chart: no month has 5 or more reports.

Cat1 report

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given0 reports

No chart: no month has 5 or more reports.

The month is the month in which FDA received the report. Each chart has its own scale. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

Reports by year

  • Dog
  • Cat
  • Horse
  • Other or not given
Reports that name hydrocortisone + ketoconazole, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
202670007
20251100011
20241600016
202381009
202260006
202120002
202030003
201940004
201854009
201761007
201620002
201520002
201430003
201320002
201220002

2026 has the reports that FDA received through May 2026. Download the years (CSV)

What the reports record

Outcome at the time of the report

  • Recovered/Normal14.1%12
  • Recovered with Sequela[recovered, with a lasting effect]4.7%4
  • Ongoing44.7%38
  • Died1.2%1
  • Euthanized2.4%2
  • Outcome Unknown31.8%27

An outcome in a report is not proof that the drug caused it. The person who sends the report gives the outcome. Each share is of the 85 reports that name hydrocortisone + ketoconazole.

A report about more than one animal can have more than one outcome.

Kind of report

  • Safety issue81.2%69
  • Lack of expected effectiveness7.1%6
  • Both safety and lack of expected effectiveness9.4%8
  • Manufacturing or product defect1.2%1
  • Other1.2%1

83 reports say if the event was serious. 62.7% of them have the serious flag. The person who sends the report sets the flag.

Show age, weight, breed and route

Age of the animal

  • Under 1 year1.2%1
  • 1 to 3 years18.8%16
  • 4 to 7 years28.2%24
  • 8 to 11 years31.8%27
  • 12 years and over20%17
  • Age not given0%0

Weight of the animal

  • Under 5 kg (11 lb)10.6%9
  • 5 to 9.9 kg (11 to 22 lb)30.6%26
  • 10 to 24.9 kg (22 to 55 lb)25.9%22
  • 25 to 44.9 kg (55 to 99 lb)24.7%21
  • 45 kg and over (99 lb and over)3.5%3
  • Weight not given4.7%4

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Auricular (Otic)51.8%44
  • Topical7.1%6
  • Parenteral1.2%1

Each bar is on a scale of 0 to 100%.

Approved animal drugs with these active ingredients (FDA Green Book)

This section is reference data. It has no report count.

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand.

The Green Book lists no approved animal drug with these active ingredients. FDA also receives reports for human drugs and compounded drugs that veterinarians prescribe.

Other pages with one of these ingredients

A report names a drug by its set of active ingredients. Each set has its own page. The list is in order of name.

Next in the A to Z list

All drugs by active ingredient. Brand names A to Z

FDA pages for this drug

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

Cite this page

Pet Drug Reports. Hydrocortisone + Ketoconazole: adverse event reports that FDA received. https://petdrugreports.com/drug/hydrocortisone-ketoconazole/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

Where the data come from

The counts come from the openFDA Animal and Veterinary adverse event files, export of 30 Oct 2026. The files have the reports that the FDA Center for Veterinary Medicine received through 26 Jun 2026. The files mask brand and manufacturer names. The site counts a drug by the active ingredients that each record gives, and gives no count to a brand, an application or a company. Ingredient names and the lists of approved products follow the FDA Green Book of 2 Nov 2026. The site does not use the application number that a record has.

The site does not publish report text, lot numbers or details of a reporter. FDA's record is the authority. See how the site counts reports, the data sources and the corrections page.

Questions about these reports

Which brand are these reports about?

The openFDA records give the value "MSK" for the brand name and for the manufacturer name of each drug. FDA says that MSK means "masked". So the site cannot count a report for a brand. The Green Book lists no brand name for exactly these active ingredients.

Do the reports show that the drug caused the signs?

No. FDA states this about the data.

When looking at the results, be aware that there is no certainty that the reported drug or device caused the adverse event.

The adverse event may have been related to an underlying disease, other drugs used at the same time or other non-drug related sources.

FDA Center for Veterinary Medicine. Source: Adverse Event Reports for Animal Drugs and Devices

How many reports did FDA receive in the latest 12 months?

FDA received 10 reports in the 12 months to June 2026. It received 13 reports in the 12 months before. FDA says that a report can take 3 to 6 months to reach the public data. The newest months can get more reports in a later update.

What kinds of report are in the count?

Of the 85 reports received from March 2012 to May 2026, 81.2% are about a safety issue only. 16.5% are about a lack of expected effectiveness, alone or with a safety issue. 1.2% are about a defect of the product or its package.