Clotrimazole + Gentamicin Sulfate: adverse event reports that FDA received

Name: Clotrimazole + Gentamicin Sulfate: adverse event reports that FDA received, by year and species
Creator: Pet Drug Reports
License: https://creativecommons.org/publicdomain/zero/1.0/

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 2 Oct 2026. The data have the reports that FDA received through 26 Jun 2026.

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

Contacting a veterinarian How to report to FDA

From July 2013 to October 2025, FDA received 22 adverse event reports that name a drug with clotrimazole and gentamicin sulfate as its active ingredients. Of the 22 reports, 21 (95.5%) are about dogs. 1 report is about cats (4.5%).

In January to March 2026, FDA received no reports that name this drug. 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 95.5% 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 11 Oct 2026, changed no count of this page.

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

All updates Feed 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 22 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.

Lack of efficacy - NOS[the product did not have the expected effect]18.2%4 reports
Ear discharge13.6%3 reports
Ear infection NOS[NOS: not otherwise specified]13.6%3 reports
Other ear disorder NOS[NOS: not otherwise specified]13.6%3 reports
Vomiting13.6%3 reports
Ataxia[unsteady, uncoordinated movement]9.1%2 reports
Cardiac disorder NOS[heart problem, type not specified]9.1%2 reports
Elevated alanine aminotransferase (ALT)[a liver enzyme above the normal range]9.1%2 reports
Lethargy[unusually tired or inactive]9.1%2 reports
Other abnormal test result NOS[abnormal laboratory result, type not specified]9.1%2 reports
Otitis externa[outer ear inflammation]9.1%2 reports
Pruritus[itching]9.1%2 reports
Weight loss9.1%2 reports
Abscess NOS[NOS: not otherwise specified]4.5%1 reports

Show the next 16 signs

Allergic reaction4.5%1 reports
Allergy NOS[NOS: not otherwise specified]4.5%1 reports
Application site excoriation[excoriation where the product was applied]4.5%1 reports
Application site irritation[irritation where the product was applied]4.5%1 reports
Application site papule[papule where the product was applied]4.5%1 reports
Application site pruritus[itching where the product was applied]4.5%1 reports
Application site self trauma[self trauma where the product was applied]4.5%1 reports
Atopic allergy NOS[NOS: not otherwise specified]4.5%1 reports
Bacterial skin infection NOS[NOS: not otherwise specified]4.5%1 reports
Behavioural disorder NOS[behaviour change, type not specified]4.5%1 reports
Bronchitis4.5%1 reports
Cardiac failure4.5%1 reports
Circling - neurological disorder4.5%1 reports
Deafness4.5%1 reports
Death4.5%1 reports
Dermal cyst(s)4.5%1 reports

The list shows 30 of 80 coded signs. A report is not proof that a drug caused a sign. Download all signs (CSV)

Reports by species

Dog95.5%21
Cat4.5%1

The share is of all 22 reports that name clotrimazole + gentamicin sulfate. The other reports give a different species or no species.

Reports for each month, Jul 2021 to Jun 2026

Dog6 reports

No chart: no month has 5 or more reports.

Cat0 reports

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 clotrimazole + gentamicin sulfate, by the year in which FDA received them and by species
Year	Dog	Cat	All species
2025	2	0	2
2024	1	0	1
2022	2	0	2
2021	2	0	2
2020	2	0	2
2019	3	1	4
2017	1	0	1
2016	2	0	2
2014	5	0	5
2013	1	0	1

2025 has the reports that FDA received through Oct 2025. Download the years (CSV)

What the reports record

Outcome at the time of the report

Recovered/Normal31.8%7
Recovered with Sequela[recovered, with a lasting effect]4.5%1
Ongoing13.6%3
Died4.5%1
Euthanized0%0
Outcome Unknown45.5%10

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 22 reports that name clotrimazole + gentamicin sulfate.

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

Kind of report

Safety issue100%22
Lack of expected effectiveness0%0
Both safety and lack of expected effectiveness0%0
Manufacturing or product defect0%0
Other0%0

22 reports say if the event was serious. 86.4% 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 year9.1%2
1 to 3 years27.3%6
4 to 7 years31.8%7
8 to 11 years13.6%3
12 years and over9.1%2
Age not given9.1%2

Weight of the animal

Under 5 kg (11 lb)13.6%3
5 to 9.9 kg (11 to 22 lb)4.5%1
10 to 24.9 kg (22 to 55 lb)36.4%8
25 to 44.9 kg (55 to 99 lb)22.7%5
45 kg and over (99 lb and over)13.6%3
Weight not given9.1%2

Breed, where the report gives one breed

Domestic Shorthair4.5%1
Beagle4.5%1
Bichon Frise4.5%1
Boxer4.5%1
French Bulldog4.5%1
Chinese Crested Dog – Hairless4.5%1
Great Pyrenees4.5%1
Maltese4.5%1

A breed with many animals has many reports.

Route in the report

Auricular (Otic)54.5%12
Topical4.5%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.

No approved product has exactly this set of active ingredients. The ingredient field of a report can be incomplete. The approved products below have all the ingredients of this page and one or more other ingredients.

Applications in the Green Book of 2 Nov 2026, pioneer applications (NADA) first
Brand name	Active ingredients	Sponsor	Approved species	Application
Otomax	Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate	Intervet, Inc.	Dogs	NADA 140-896
Mometamax Otic Suspension	Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate	Intervet, Inc.	Dogs	NADA 141-177
Vetro-Max	Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate	Fougera Pharmaceuticals, LLC	Dogs	ANADA 200-283
GBC Ointment	Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate	Cronus Pharma Specialities India Private Ltd.	Dogs	ANADA 200-287
Mometavet	Clotrimazole, Gentamicin Sulfate, Mometasone furoate	Dechra Veterinary Products LLC	Dogs	ANADA 200-536
Tri-Otic Ointmentapproval withdrawn	Betamethasone Valerate, Clotrimazole, Gentamicin Sulfate	Med-Pharmex, Inc.	Dogs	ANADA 200-229

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.

FDA pages for this drug

How to Report Animal Drug and Device Side Effects and Product ProblemsThe FDA page that tells an owner or a veterinarian how to send a report.
Animal Drugs @ FDAThe search page of the Green Book, the FDA list of approved animal drugs.

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

Cite this page

Pet Drug Reports. Clotrimazole + Gentamicin Sulfate: adverse event reports that FDA received. https://petdrugreports.com/drug/clotrimazole-gentamicin-sulfate/ Source: FDA Center for Veterinary Medicine, openFDA Animal and Veterinary adverse event reports, export of 30 Oct 2026. Reports received through 26 Jun 2026.

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 2 reports in the 12 months to June 2026. It received 1 report 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 22 reports received from July 2013 to October 2025, 100% are about a safety issue only.