Betamethasone + Florfenicol + Terbinafine
2,221 adverse event reports submitted to the FDA
Active Ingredients
Administration Routes
Species Affected
Most Affected Breeds
Most Reported Reactions
Outcome Breakdown
Data Summary
| Metric | Value |
|---|---|
| Total adverse event reports | 2,221 |
| Reports involving death | 38 |
| Case-fatality rate (reported events) | 170.0% |
| Distinct species in reports | 5 |
| 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 + Florfenicol + Terbinafine Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 2,221 adverse event reports referencing Betamethasone + Florfenicol + Terbinafine, including 38 reports in which the animal died — a 170.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Betamethasone, Florfenicol, Terbinafine. 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 Betamethasone + Florfenicol + Terbinafine reports are Dog (1,955 reports), Cat (136 reports), Unknown (115 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (296), Dog (unknown) (198), Unknown (132) 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 + Florfenicol + Terbinafine are Lack of efficacy - NOS (1,128), Ear discharge (159), Loss of hearing (112), Vomiting (100). Of the 2,106 reports with a coded outcome, Outcome Unknown is the leading category at 60.3%. 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 Betamethasone + Florfenicol + Terbinafine.
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
Read our methodology — how this data is sourced, computed, and verified.