Florfenicol, Terbinafine, Mometasone

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14 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.
14
Total Reports
2
Deaths Reported
1430.0%
Death Rate

Active Ingredients

Florfenicol, Terbinafine, Mometasone

Administration Routes

Auricular (Otic)UnknownTopical

Species Affected

Dog 14

Most Affected Breeds

Bulldog - French 2
Maltese 2
Retriever - Labrador 2
Terrier - Yorkshire 1
American Pit Bull Terrier 1
Poodle - Toy 1
Greater Swiss Mountain Dog 1
Boxer (German Boxer) 1
Terrier (unspecified) 1
Shepherd Dog - German 1

Most Reported Reactions

Ear infection NOS 4
Lack of efficacy - NOS 3
Inappropriate urination 3
Tachycardia 3
Decreased drinking 3
Elevated serum alkaline phosphatase (ALP) 3
Prescribing error 3
Stenotic ear canal 3
Proteinuria 2
Blood and lymphatic system disorder NOS 2
Disorder of red blood cell NOS 2
Hyperproteinaemia 2

Outcome Breakdown

Outcome Unknown
5 (35.7%)
Ongoing
4 (28.6%)
Recovered/Normal
3 (21.4%)
Euthanized
2 (14.3%)

Data Summary

Metric Value
Total adverse event reports 14
Reports involving death 2
Case-fatality rate (reported events) 1430.0%
Distinct species in reports 1
Distinct breeds in reports 11
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, Mometasone Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 14 adverse event reports referencing Florfenicol, Terbinafine, Mometasone, including 2 reports in which the animal died — a 1430.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Florfenicol, Terbinafine, Mometasone. Reported administration routes include Auricular (Otic), Unknown, 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, Mometasone reports are Dog (14 reports), with Dog accounting for the largest share. Within those species, Bulldog - French (2), Maltese (2), Retriever - Labrador (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, Mometasone are Ear infection NOS (4), Lack of efficacy - NOS (3), Inappropriate urination (3), Tachycardia (3). Of the 14 reports with a coded outcome, Outcome Unknown is the leading category at 35.7%. 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, Mometasone.

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