Genta/Momet/Clotrim Ear Oint

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2,462 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.
2,462
Total Reports
69
Deaths Reported
280.0%
Death Rate

Active Ingredients

Genta/Momet/Clotrim Ear Oint

Administration Routes

Auricular (Otic)TopicalUnknownOralOphthalmicOtherIntraocularRectal

Species Affected

Dog 2,177
Unknown 241
Cat 38
Human 6

Most Affected Breeds

Crossbred Canine/dog 438
Unknown 249
Retriever - Labrador 184
Terrier - Yorkshire 95
Chihuahua 77
Retriever - Golden 75
Pug 70
Boxer (German Boxer) 63
Shepherd Dog - German 61
Shih Tzu 61

Most Reported Reactions

Deafness 1,318
Drug administration duration too long 371
Partial deafness 342
Incorrect dose administered NOS 148
Overdose 148
Underdose 129
Product problem 111
Loss of hearing 85
Lack of efficacy - NOS 76
Drug dose prescribing error 73
Product Defect, General 72
Lethargy (see also Central nervous system depression in 'Neurological') 71

Outcome Breakdown

Recovered with Sequela
1,224 (55.1%)
Recovered/Normal
421 (18.9%)
Outcome Unknown
265 (11.9%)
Ongoing
243 (10.9%)
Euthanized
43 (1.9%)
Died
26 (1.2%)

Data Summary

Metric Value
Total adverse event reports 2,462
Reports involving death 69
Case-fatality rate (reported events) 280.0%
Distinct species in reports 4
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/Momet/Clotrim Ear Oint Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 2,462 adverse event reports referencing Genta/Momet/Clotrim Ear Oint, including 69 reports in which the animal died — a 280.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Genta/Momet/Clotrim Ear Oint. Reported administration routes include Auricular (Otic), Topical, Unknown, 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/Momet/Clotrim Ear Oint reports are Dog (2,177 reports), Unknown (241 reports), Cat (38 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (438), Unknown (249), Retriever - Labrador (184) 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/Momet/Clotrim Ear Oint are Deafness (1,318), Drug administration duration too long (371), Partial deafness (342), Incorrect dose administered NOS (148). Of the 2,222 reports with a coded outcome, Recovered with Sequela is the leading category at 55.1%. 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/Momet/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

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial