Clotrimazole + Gentamicin + Mometasone

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845 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.
845
Total Reports
12
Deaths Reported
140.0%
Death Rate

Active Ingredients

ClotrimazoleGentamicinMometasone

Administration Routes

Auricular (Otic)UnknownTopical

Species Affected

Dog 821
Unknown 17
Cat 5
Human 2

Most Affected Breeds

Unknown 129
Retriever - Labrador 90
Pit Bull 46
Chihuahua 43
Terrier - Yorkshire 39
Shepherd Dog - German 32
Retriever - Golden 32
Boxer (German Boxer) 24
Maltese 21
Terrier (unspecified) 17

Most Reported Reactions

Temporary deafness 459
PR-EAR(S), LESION(S) 275
Loss of hearing 228
Deafness 77
Partial deafness 7
Potency, Low 7
Vomiting 5
Underdose 4
Drug administration duration too long 4
Lethargy (see also Central nervous system depression in 'Neurological') 4
Unclassifiable adverse event 4
Lot # and /or Expiration date missing 4

Outcome Breakdown

Ongoing
351 (42.3%)
Outcome Unknown
240 (29.0%)
Recovered/Normal
204 (24.6%)
Recovered with Sequela
22 (2.7%)
Died
8 (1.0%)
Euthanized
4 (0.5%)

Data Summary

Metric Value
Total adverse event reports 845
Reports involving death 12
Case-fatality rate (reported events) 140.0%
Distinct species in reports 4
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 3

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

Clotrimazole + Gentamicin + Mometasone Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 845 adverse event reports referencing Clotrimazole + Gentamicin + Mometasone, including 12 reports in which the animal died — a 140.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Clotrimazole, Gentamicin, Mometasone. Reported administration routes include Auricular (Otic), Unknown, Topical. 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 Clotrimazole + Gentamicin + Mometasone reports are Dog (821 reports), Unknown (17 reports), Cat (5 reports), with Dog accounting for the largest share. Within those species, Unknown (129), Retriever - Labrador (90), Pit Bull (46) 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 Clotrimazole + Gentamicin + Mometasone are Temporary deafness (459), PR-EAR(S), LESION(S) (275), Loss of hearing (228), Deafness (77). Of the 829 reports with a coded outcome, Ongoing 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 Clotrimazole + Gentamicin + Mometasone.

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