Betamethasone + Clotrimazole + Gentamicin

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77 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.
77
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

BetamethasoneClotrimazoleGentamicin

Administration Routes

Auricular (Otic)UnknownOralHemodialysisTopical

Species Affected

Dog 70
Unknown 7

Most Affected Breeds

Unknown 10
Retriever - Labrador 9
Crossbred Canine/dog 7
Pug 4
Maltese 4
Poodle (unspecified) 3
Terrier - Yorkshire 3
Dog (other) 3
Chihuahua 3
Schnauzer (unspecified) 3

Most Reported Reactions

Deafness 20
Partial deafness 16
Drug administration duration too long 16
Temporary deafness 15
Underdose 6
Application site erythema 6
Application site pain 4
Application site papule 3
Vomiting 3
Overdose 3
Containers, Leaking 2
Incorrect route of drug administration 2

Outcome Breakdown

Outcome Unknown
31 (44.9%)
Recovered/Normal
21 (30.4%)
Recovered with Sequela
10 (14.5%)
Ongoing
7 (10.1%)

Data Summary

Metric Value
Total adverse event reports 77
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 2
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.

Betamethasone + Clotrimazole + Gentamicin Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 77 adverse event reports referencing Betamethasone + Clotrimazole + Gentamicin, including 0 reports in which the animal died — a 0.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Betamethasone, Clotrimazole, Gentamicin. Reported administration routes include Auricular (Otic), Unknown, Oral, Hemodialysis. 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 Betamethasone + Clotrimazole + Gentamicin reports are Dog (70 reports), Unknown (7 reports), with Dog accounting for the largest share. Within those species, Unknown (10), Retriever - Labrador (9), Crossbred Canine/dog (7) 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 Betamethasone + Clotrimazole + Gentamicin are Deafness (20), Partial deafness (16), Drug administration duration too long (16), Temporary deafness (15). Of the 69 reports with a coded outcome, Outcome Unknown is the leading category at 44.9%. 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 Betamethasone + Clotrimazole + Gentamicin.

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