0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta

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12 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.
12
Total Reports
1
Deaths Reported
830.0%
Death Rate

Active Ingredients

0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta

Administration Routes

Auricular (Otic)

Species Affected

Dog 11
Cat 1

Most Affected Breeds

Bulldog - English 2
Retriever - Golden 1
Shiba Inu 1
Chihuahua 1
Poodle - Standard 1
Domestic Shorthair 1
Deutsche Dogge, Great Dane 1
Spaniel - Boykin 1
Rottweiler 1
Terrier - Bull - Staffordshire 1

Most Reported Reactions

Deafness 4
Application site reaction NOS 2
Loss of hearing 2
Application site reddening 2
Deafness NOS 1
Behavioural disorder NOS 1
Death by euthanasia 1
Mucus in eye 1
Nasal discharge 1
Schirmer tear test 1
Keratoconjunctivitis sicca 1
Corneal ulcer 1

Outcome Breakdown

Outcome Unknown
4 (33.3%)
Recovered/Normal
4 (33.3%)
Recovered with Sequela
2 (16.7%)
Euthanized
1 (8.3%)
Ongoing
1 (8.3%)

Data Summary

Metric Value
Total adverse event reports 12
Reports involving death 1
Case-fatality rate (reported events) 830.0%
Distinct species in reports 2
Distinct breeds in reports 11
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.

0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 12 adverse event reports referencing 0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta, including 1 reports in which the animal died — a 830.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: 0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta. Reported administration route is 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 0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta reports are Dog (11 reports), Cat (1 reports), with Dog accounting for the largest share. Within those species, Bulldog - English (2), Retriever - Golden (1), Shiba Inu (1) 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 0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta are Deafness (4), Application site reaction NOS (2), Loss of hearing (2), Application site reddening (2). Of the 12 reports with a coded outcome, Outcome Unknown is the leading category at 33.3%. 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 0.15% Ketoconazole, 0.15% Chlorhexidine In Usp Trizedta.

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