Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride
3,430 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 | 3,430 |
| Reports involving death | 86 |
| Case-fatality rate (reported events) | 250.0% |
| 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.
Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 3,430 adverse event reports referencing Florfenicol + Mometasone Furoate + Terbinafine Hydrochloride, including 86 reports in which the animal died — a 250.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Florfenicol, Mometasone Furoate, Terbinafine Hydrochloride. Reported administration routes include Unknown, Auricular (Otic), Topical, Other. 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 + Mometasone Furoate + Terbinafine Hydrochloride reports are Dog (2,198 reports), Unknown (674 reports), Cat (471 reports), with Dog accounting for the largest share. Within those species, Unknown (761), Domestic Shorthair (294), Retriever - Labrador (197) 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 + Mometasone Furoate + Terbinafine Hydrochloride are Lack of efficacy - NOS (552), Ataxia (474), Head tilt - ear disorder (349), Vomiting (301). Of the 2,760 reports with a coded outcome, Outcome Unknown is the leading category at 52.1%. 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 + Mometasone Furoate + Terbinafine Hydrochloride.
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.