Ketoconazole + Tris-Edta + Phytosphingosine

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

0.0%

Death Rate

Active Ingredients

Ketoconazole + Tris-Edta + Phytosphingosine

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 16

Most Affected Breeds

Retriever - Labrador 4

Shih Tzu 2

Shar Pei 1

Terrier - Boston 1

Chihuahua 1

Dog (unknown) 1

Shepherd Dog - Australian 1

Poodle (unspecified) 1

Setter - English 1

Terrier (unspecified) 1

Most Reported Reactions

Behavioural disorder NOS 4

Lack of efficacy - NOS 3

Vomiting 3

Nasal dryness 3

Vocalisation 2

Pinnal erythema 2

Head shake - ear disorder 2

Uncomfortable 2

Unsteady gait 2

Corneal ulcer 2

Panting 2

Horner's syndrome 2

Outcome Breakdown

Outcome Unknown

6 (37.5%)

Ongoing

6 (37.5%)

Recovered/Normal

4 (25.0%)

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