0.15% Ketoconazole, Trizedta (Tromethamine Usp, Disodium Edta Dihydrate)

16 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.

Total Reports

Deaths Reported

620.0%

Death Rate

Active Ingredients

0.15% Ketoconazole, Trizedta (Tromethamine Usp, Disodium Edta Dihydrate)

Administration Routes

Auricular (Otic)UnknownTopical

Species Affected

Dog 16

Most Affected Breeds

Boxer (German Boxer) 3

Pug 2

Dachshund (unspecified) 2

Spaniel - Cocker American 1

Shih Tzu 1

Shepherd Dog - German 1

Retriever - Golden 1

Maltese 1

Terrier - Bull - Staffordshire 1

Terrier (unspecified) 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 4

Lack of efficacy - NOS 3

Monocytosis 3

Seizure NOS 2

Licking 2

Decreased appetite 2

Otitis externa 2

Alopecia 2

Pain NOS 2

Constipation 2

Vocalisation 2

Abnormal radiograph finding 2

Outcome Breakdown

Outcome Unknown

7 (43.8%)

Ongoing

5 (31.3%)

Recovered/Normal

3 (18.8%)

Euthanized

1 (6.3%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.