Drug profile

The FDA adverse-event record for Florfenicol, Terbinafine, Betamethasone Acetate

557 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Florfenicol, Terbinafine, Betamethasone Acetate. See the species affected, top reactions, and outcomes below.

557
adverse-event reports
4.3%
death-coded share
Dog
most-reported species
79
Deafness - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
557
Total Reports
24
Deaths Reported
4.3%
Death Rate

Active Ingredients

Florfenicol, Terbinafine, Betamethasone Acetate

Administration Routes

Auricular (Otic)UnknownOphthalmicTopicalOralOther

Species Affected

Dog 419
Cat 112
Unknown 18
Human 8

Most Affected Breeds

Domestic Shorthair 75
Retriever - Labrador 45
Unknown 26
Shih Tzu 23
Chihuahua 21
Dog (unknown) 21
Maltese 20
Bulldog - French 18
Terrier - Yorkshire 17
Retriever - Golden 16

Most Reported Reactions

Deafness 79
Lack of efficacy - NOS 56
Vomiting 45
Head shake - ear disorder 43
Not eating 41
Lethargy (see also Central nervous system depression in 'Neurological') 40
Loss of hearing 38
Head tilt - ear disorder 37
Ataxia 37
Corneal ulcer 34
Horner's syndrome 31
Ear discharge 31

Outcome Breakdown

Outcome Unknown
299 (55.3%)
Recovered/Normal
136 (25.1%)
Ongoing
63 (11.6%)
Recovered with Sequela
19 (3.5%)
Euthanized
13 (2.4%)
Died
11 (2.0%)

Florfenicol, Terbinafine, Betamethasone Acetate Adverse Event Insights

557 reports name Florfenicol, Terbinafine, Betamethasone Acetate; 24 recorded a death outcome (4.3% of reported events, not a population-level mortality rate). Active ingredient: Florfenicol, Terbinafine, Betamethasone Acetate. Administration routes: Auricular (Otic), Unknown, Ophthalmic, Topical.

By species: Dog (419 reports), Cat (112 reports), Unknown (18 reports). By breed: Domestic Shorthair (75), Retriever - Labrador (45), Unknown (26).

Leading clinical signs: Deafness (79), Lack of efficacy - NOS (56), Vomiting (45), Head shake - ear disorder (43). Outcome, 541 coded reports: Outcome Unknown leads at 55.3%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.