Florfenicol + Mometasone Furoate + Terbinafine

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286 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.
286
Total Reports
19
Deaths Reported
660.0%
Death Rate

Active Ingredients

FlorfenicolMometasone FuroateTerbinafine

Administration Routes

Auricular (Otic)UnknownIntraocularTopicalOphthalmic

Species Affected

Dog 241
Cat 38
Human 5
Unknown 2

Most Affected Breeds

Poodle (unspecified) 26
Domestic Shorthair 24
Beagle 24
Unknown 20
Retriever - Labrador 19
Retriever - Golden 14
Dog (unknown) 13
Chihuahua 12
Bulldog - French 11
Shih Tzu 7

Most Reported Reactions

Lack of efficacy (fungi) - NOS 46
Head shake - ear disorder 39
Lack of efficacy - NOS 37
Ear discharge 36
Lack of efficacy (bacteria) - NOS 30
Ataxia 29
Vomiting 27
Not eating 25
Head tilt - ear disorder 24
Decreased appetite 21
Ear pain 20
Ear canal erythema 20

Outcome Breakdown

Outcome Unknown
118 (41.5%)
Recovered/Normal
97 (34.2%)
Ongoing
30 (10.6%)
Recovered with Sequela
20 (7.0%)
Euthanized
15 (5.3%)
Died
4 (1.4%)

Data Summary

Metric Value
Total adverse event reports 286
Reports involving death 19
Case-fatality rate (reported events) 660.0%
Distinct species in reports 4
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 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 286 adverse event reports referencing Florfenicol + Mometasone Furoate + Terbinafine, including 19 reports in which the animal died — a 660.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Florfenicol, Mometasone Furoate, Terbinafine. Reported administration routes include Auricular (Otic), Unknown, Intraocular, 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 + Mometasone Furoate + Terbinafine reports are Dog (241 reports), Cat (38 reports), Human (5 reports), with Dog accounting for the largest share. Within those species, Poodle (unspecified) (26), Domestic Shorthair (24), Beagle (24) 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 are Lack of efficacy (fungi) - NOS (46), Head shake - ear disorder (39), Lack of efficacy - NOS (37), Ear discharge (36). Of the 284 reports with a coded outcome, Outcome Unknown is the leading category at 41.5%. 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.

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