Gentamicin + Mometasone + Clotrimazole

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274 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
274
Total Reports
22
Deaths Reported
800.0%
Death Rate

Active Ingredients

Gentamicin + Mometasone + Clotrimazole

Administration Routes

Auricular (Otic)UnknownTopicalOralIntraocularOtherOphthalmic

Species Affected

Dog 261
Cat 13

Most Affected Breeds

Retriever - Labrador 44
Shih Tzu 13
Spaniel - Cocker American 11
Pit Bull 11
Retriever - Golden 11
Crossbred Canine/dog 10
Boxer (German Boxer) 9
Chihuahua 9
Maltese 8
Shepherd Dog - German 8

Most Reported Reactions

Emesis 74
Vomiting 44
Lethargy (see also Central nervous system depression in 'Neurological') 36
Lack of efficacy - NOS 32
Behavioural disorder NOS 25
Diarrhoea 16
Not eating 15
Other abnormal test result NOS 13
Death by euthanasia 13
Anorexia 12
Seizure NOS 12
Lethargy (see also Central nervous system depression in Neurological) 12

Outcome Breakdown

Recovered/Normal
116 (42.3%)
Outcome Unknown
74 (27.0%)
Ongoing
50 (18.2%)
Euthanized
13 (4.7%)
Recovered with Sequela
12 (4.4%)
Died
9 (3.3%)

Data Summary

Metric Value
Total adverse event reports 274
Reports involving death 22
Case-fatality rate (reported events) 800.0%
Distinct species in reports 2
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Gentamicin + Mometasone + Clotrimazole Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 274 adverse event reports referencing Gentamicin + Mometasone + Clotrimazole, including 22 reports in which the animal died — a 800.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Gentamicin + Mometasone + Clotrimazole. Reported administration routes include Auricular (Otic), Unknown, Topical, Oral. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Gentamicin + Mometasone + Clotrimazole reports are Dog (261 reports), Cat (13 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (44), Shih Tzu (13), Spaniel - Cocker American (11) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Gentamicin + Mometasone + Clotrimazole are Emesis (74), Vomiting (44), Lethargy (see also Central nervous system depression in 'Neurological') (36), Lack of efficacy - NOS (32). Of the 274 reports with a coded outcome, Recovered/Normal is the leading category at 42.3%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Gentamicin + Mometasone + Clotrimazole.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial