Pet Drug Reports

Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate (Easotic)adverse event reports that FDA received

Combination of 3 active ingredients

The name in brackets is a brand name with 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.

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From March 2012 to June 2026, FDA received 1,861 adverse event reports that name this drug. Its active ingredients are gentamicin sulfate, hydrocortisone aceponate and miconazole nitrate. Of the 1,861 reports, 817 (43.9%) are about dogs.

In January to March 2026, FDA received 38 reports that name this drug. The signs that appear in the largest number of the 1,861 reports are "Dispenser, Abnormal", "Uncoded sign" and "Difficulty of Use". A report is not proof that a drug caused a sign.

Reports that name this drug rose by 4.2% in the 12 months to June 2026, compared with the 12 months before. Reports for all animal drugs fell by 4.6% in the same periods. The newest months can get more reports in a later update. Reports about dogs are 43.9% of the reports that name this drug, and 72.6% of all reports.

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 38 reports that name gentamicin sulfate + hydrocortisone aceponate + miconazole nitrate: 37 dog, 0 cat, 0 horse, 1 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 1,861 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. Dispenser, Abnormal[a product quality report, not a sign in an animal]32.8%611 reports
  2. Uncoded sign[a sign with no matching dictionary term]16.7%311 reports
  3. Difficulty of Use[a product quality report, not a sign in an animal]16.4%305 reports
  4. Loss of hearing16.3%304 reports
  5. Product defect, product difficult to use/handle[a product quality report, not a sign in an animal]8.6%160 reports
  6. Hearing affected7.9%147 reports
  7. Administration device NOS, priming issue7%130 reports
  8. Product Defect, General[a product quality report, not a sign in an animal]5.9%110 reports
  9. Lack of efficacy - NOS[the product did not have the expected effect]4.5%83 reports
  10. Administration device NOS, abnormal3.9%73 reports
  11. Appearance, Abnormal[a product quality report, not a sign in an animal]3%56 reports
  12. Administration device NOS, malfunction3%55 reports
  13. Containers, Damaged[a product quality report, not a sign in an animal]2.5%47 reports
  14. Lethargy[unusually tired or inactive]2.5%47 reports
Show the next 16 signs
  1. Vomiting2%38 reports
  2. Underfilling, Container[a product quality report, not a sign in an animal]1.9%35 reports
  3. Containers, Leaking[a product quality report, not a sign in an animal]1.7%32 reports
  4. Deafness1.5%27 reports
  5. Diarrhoea[diarrhea]1.1%21 reports
  6. Lack of efficacy (bacteria) - NOS[the product did not have the expected effect: target not specified]1.1%21 reports
  7. Behavioural disorder NOS[behaviour change, type not specified]1%19 reports
  8. Pinnal erythema1%18 reports
  9. Product problem[a product quality report, not a sign in an animal]1%18 reports
  10. Head shake - ear disorder0.9%17 reports
  11. Ataxia[unsteady, uncoordinated movement]0.9%16 reports
  12. Containers, Abnormal[a product quality report, not a sign in an animal]0.8%15 reports
  13. Not eating0.8%15 reports
  14. Application site erythema[reddened skin where the product was applied]0.8%14 reports
  15. Head tilt - ear disorder0.8%14 reports
  16. Ear discharge0.7%13 reports

The list shows 30 of 437 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

  • Dog43.9%817
  • Cat0.9%17
  • Human exposure0.5%9

The share is of all 1,861 reports that name gentamicin sulfate + hydrocortisone aceponate + miconazole nitrate. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog396 reports. Largest count in one month: 15 (Dec 2024)
Cat3 reports

No chart: no month has 5 or more reports.

Horse0 reports

No chart: no month has 5 or more reports.

Other or not given416 reports. Largest count in one month: 21 (Sep 2025)

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 gentamicin sulfate + hydrocortisone aceponate + miconazole nitrate, by the year in which FDA received them and by species
YearDogCatHorseOther or not givenAll species
20265600157
202511700119236
2024921074167
2023621084147
2022421099142
2021530099152
2020680078146
201700011
2016300710
20156220130194
201411340116233
20139340157254
2012564062122

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

What the reports record

Outcome at the time of the report

  • Recovered/Normal15.4%287
  • Recovered with Sequela[recovered, with a lasting effect]1.9%35
  • Ongoing1.5%28
  • Died0.4%7
  • Euthanized0.6%12
  • Outcome Unknown25.6%476

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 1,861 reports that name gentamicin sulfate + hydrocortisone aceponate + miconazole nitrate.

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

Kind of report

  • Safety issue38.8%722
  • Lack of expected effectiveness3.9%72
  • Both safety and lack of expected effectiveness2.3%43
  • Manufacturing or product defect55%1,024
  • Other0%0

843 reports say if the event was serious. 58.6% 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%22
  • 1 to 3 years5.3%99
  • 4 to 7 years8.1%151
  • 8 to 11 years14.5%270
  • 12 years and over13.8%256
  • Age not given57.1%1,063

Weight of the animal

  • Under 5 kg (11 lb)5.6%104
  • 5 to 9.9 kg (11 to 22 lb)10.5%195
  • 10 to 24.9 kg (22 to 55 lb)11.5%214
  • 25 to 44.9 kg (55 to 99 lb)12%224
  • 45 kg and over (99 lb and over)1.7%32
  • Weight not given58.7%1,092

Breed, where the report gives one breed

A breed with many animals has many reports.

Route in the report

  • Auricular (Otic)29.4%548
  • Topical1.5%27
  • Oral1.1%20
  • Ophthalmic0.2%4
  • Buccal0.1%1
  • Irrigation0.1%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.

Brand names

  • Easotic

What the Green Book records give

Applications with an approval in force
1
Approved species
Dogs
Dose forms
Otic Suspension
Routes
Otic
Sale
RX (prescription)
Earliest approval date in the records

The species, dose forms and routes are the words of the Green Book records for all the applications together. One product can have fewer. The label of a product gives its approved use.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand nameActive ingredientsSponsorApproved speciesApplication
EasoticGentamicin Sulfate, Hydrocortisone aceponate, Miconazole NitrateVirbac AH, Inc.DogsNADA 141-330

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. Gentamicin Sulfate + Hydrocortisone aceponate + Miconazole Nitrate: adverse event reports that FDA received. https://petdrugreports.com/drug/gentamicin-sulfate-hydrocortisone-aceponate-miconazole-nitrate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of . Reports received through .

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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 section of this page lists the brand names with 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 197 reports in the 12 months to June 2026. It received 189 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 1,861 reports received from March 2012 to June 2026, 38.8% are about a safety issue only. 6.2% are about a lack of expected effectiveness, alone or with a safety issue. 55% are about a defect of the product or its package.