Genta/Betamet/Clotrim Ear Oint
511 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 | 511 |
| Reports involving death | 10 |
| Case-fatality rate (reported events) | 200.0% |
| Distinct species in reports | 3 |
| Distinct breeds in reports | 20 |
| 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.
Genta/Betamet/Clotrim Ear Oint Adverse Event Insights
The FDA Center for Veterinary Medicine database currently holds 511 adverse event reports referencing Genta/Betamet/Clotrim Ear Oint, including 10 reports in which the animal died — a 200.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Genta/Betamet/Clotrim Ear Oint. Reported administration routes include Auricular (Otic), Unknown, Topical, Oral. 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 Genta/Betamet/Clotrim Ear Oint reports are Dog (403 reports), Unknown (94 reports), Cat (14 reports), with Dog accounting for the largest share. Within those species, Unknown (96), Crossbred Canine/dog (79), Retriever - Labrador (43) 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 Genta/Betamet/Clotrim Ear Oint are Deafness (225), Partial deafness (47), Drug administration duration too long (41), Applicator, Abnormal (27). Of the 417 reports with a coded outcome, Recovered with Sequela is the leading category at 45.3%. 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 Genta/Betamet/Clotrim Ear Oint.
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.