Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate
1,197 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 | 1,197 |
| Reports involving death | 27 |
| Case-fatality rate (reported events) | 230.0% |
| Distinct species in reports | 5 |
| 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.
Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 1,197 adverse event reports referencing Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate, including 27 reports in which the animal died — a 230.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate. Reported administration routes include Unknown, Auricular (Otic), Other, 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 Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate reports are Unknown (589 reports), Dog (471 reports), Cat (117 reports), with Unknown accounting for the largest share. Within those species, Unknown (608), Domestic Shorthair (70), Retriever - Labrador (62) 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 Hydrochloride/Mometasone Furoate are Tubes, Leaking (439), Lack of efficacy - NOS (124), Ataxia (114), Odor, Abnormal (79). Of the 608 reports with a coded outcome, Outcome Unknown is the leading category at 60.7%. 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 Hydrochloride/Mometasone Furoate.
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.