Drug profile

The FDA adverse-event record for Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

1,197 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate. See the species affected, top reactions, and outcomes below.

1,197
adverse-event reports
2.3%
death-coded share
Unknown
most-reported species
439
Tubes, Leaking - 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.
1,197
Total Reports
27
Deaths Reported
2.3%
Death Rate

Active Ingredients

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate

Administration Routes

UnknownAuricular (Otic)OtherTopicalOral

Species Affected

Unknown 589
Dog 471
Cat 117
Human 19
Rabbit 1

Most Affected Breeds

Unknown 608
Domestic Shorthair 70
Retriever - Labrador 62
Dog (unknown) 53
Retriever - Golden 32
Shih Tzu 25
Spaniel - Cocker American 22
Pit Bull 19
Crossbred Canine/dog 19
Pug 17

Most Reported Reactions

Tubes, Leaking 439
Lack of efficacy - NOS 124
Ataxia 114
Odor, Abnormal 79
Anorexia 75
Ear discharge 63
Head tilt - ear disorder 63
Head shake - ear disorder 62
Lethargy (see also Central nervous system depression in 'Neurological') 55
Nystagmus 50
Behavioural disorder NOS 44
Underfilling, Package 44

Outcome Breakdown

Outcome Unknown
369 (60.7%)
Recovered/Normal
206 (33.9%)
Died
14 (2.3%)
Euthanized
13 (2.1%)
Recovered with Sequela
6 (1.0%)

Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate Adverse Event Insights

1,197 reports name Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate; 27 recorded a death outcome (2.3% of reported events, not a population-level mortality rate). Active ingredient: Florfenicol/Terbinafine Hydrochloride/Mometasone Furoate. Administration routes: Unknown, Auricular (Otic), Other, Topical.

By species: Unknown (589 reports), Dog (471 reports), Cat (117 reports). By breed: Unknown (608), Domestic Shorthair (70), Retriever - Labrador (62).

Leading clinical signs: Tubes, Leaking (439), Lack of efficacy - NOS (124), Ataxia (114), Odor, Abnormal (79). Outcome, 608 coded reports: Outcome Unknown leads at 60.7%.

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.