Florfenicol, Terbinafine, Betamethasone Acetate Gel

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15 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.
15
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Florfenicol, Terbinafine, Betamethasone Acetate Gel

Administration Routes

Auricular (Otic)

Species Affected

Dog 14
Cat 1

Most Affected Breeds

Shih Tzu 2
Chihuahua 2
Retriever - Golden 2
Domestic Shorthair 1
Sheepdog (unspecified) 1
Terrier - Boston 1
Bloodhound 1
Dog (other) 1
Terrier - Jack Russell 1
Shepherd Dog - German 1

Most Reported Reactions

Loss of hearing 3
Deafness 2
Vomiting 2
Restlessness 2
Lethargy (see also Central nervous system depression in 'Neurological') 2
Application site inflammation 2
Vestibular disorder NOS 1
Inappetence 1
Swelling around eye 1
Hyphaemia 1
Third eyelid extrusion 1
Thrombocytopenia 1

Outcome Breakdown

Recovered/Normal
8 (53.3%)
Outcome Unknown
5 (33.3%)
Recovered with Sequela
1 (6.7%)
Ongoing
1 (6.7%)

Data Summary

Metric Value
Total adverse event reports 15
Reports involving death 0
Case-fatality rate (reported events) 0.0%
Distinct species in reports 2
Distinct breeds in reports 12
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.

Florfenicol, Terbinafine, Betamethasone Acetate Gel Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 15 adverse event reports referencing Florfenicol, Terbinafine, Betamethasone Acetate Gel, 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 ingredient on file: Florfenicol, Terbinafine, Betamethasone Acetate Gel. Reported administration route is Auricular (Otic). 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 Florfenicol, Terbinafine, Betamethasone Acetate Gel reports are Dog (14 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Shih Tzu (2), Chihuahua (2), Retriever - Golden (2) 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 Florfenicol, Terbinafine, Betamethasone Acetate Gel are Loss of hearing (3), Deafness (2), Vomiting (2), Restlessness (2). Of the 15 reports with a coded outcome, Recovered/Normal is the leading category at 53.3%. 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 Florfenicol, Terbinafine, Betamethasone Acetate Gel.

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