Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride

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27 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.
27
Total Reports
3
Deaths Reported
1110.0%
Death Rate

Active Ingredients

Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride

Administration Routes

TopicalUnknownCutaneousAuricular (Otic)Parenteral

Species Affected

Dog 25
Cattle 1
Cat 1

Most Affected Breeds

Retriever - Labrador 6
Retriever (unspecified) 2
Bulldog 2
Poodle (unspecified) 2
Terrier - Jack Russell 1
Rottweiler 1
Corgi - Welsh Cardigan 1
Bichon Frise 1
Retriever - Golden 1
Coton de Tuléar 1

Most Reported Reactions

Emesis 10
Lethargy (see also Central nervous system depression in 'Neurological') 6
Diarrhoea 4
Vomiting 3
Panting 3
Death 3
Behavioural disorder NOS 2
Elevated amylase 2
Vocalisation 2
Licking 2
Abdominal cavity disorder NOS 2
Anaemia NOS 2

Outcome Breakdown

Recovered/Normal
12 (44.4%)
Outcome Unknown
7 (25.9%)
Ongoing
4 (14.8%)
Died
3 (11.1%)
Recovered with Sequela
1 (3.7%)

Data Summary

Metric Value
Total adverse event reports 27
Reports involving death 3
Case-fatality rate (reported events) 1110.0%
Distinct species in reports 3
Distinct breeds in reports 19
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.

Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 27 adverse event reports referencing Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride, including 3 reports in which the animal died — a 1110.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride. Reported administration routes include Topical, Unknown, Cutaneous, Auricular (Otic). 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 Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride reports are Dog (25 reports), Cattle (1 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (6), Retriever (unspecified) (2), Bulldog (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 Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride are Emesis (10), Lethargy (see also Central nervous system depression in 'Neurological') (6), Diarrhoea (4), Vomiting (3). Of the 27 reports with a coded outcome, Recovered/Normal is the leading category at 44.4%. 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 Neomycin Sulfate, Isoflupredone Acetate And Tetracaine Hydrochloride.

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