Ketoconazole + Tromethamine + Disodium Edta Dihydrate
76 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.
76
Total Reports
1
Deaths Reported
130.0%
Death Rate
Active Ingredients
Ketoconazole + Tromethamine + Disodium Edta Dihydrate
Administration Routes
Auricular (Otic)UnknownOther
Species Affected
Dog 75
Unknown 1
Most Affected Breeds
Terrier - Yorkshire 7
Retriever - Labrador 6
Shepherd Dog - Australian 5
Pug 4
Spaniel - Cocker American 3
Poodle (unspecified) 3
Pit Bull 3
Crossbred Canine/dog 3
Maltese 3
Poodle - Miniature 3
Most Reported Reactions
Lack of efficacy - NOS 17
Vomiting 10
Head tilt - ear disorder 9
Ocular discharge 9
Ataxia 8
Behavioural disorder NOS 8
Facial paralysis 7
Nystagmus 7
Vocalisation 6
Hearing decreased 6
Ear infection NOS 6
Lethargy (see also Central nervous system depression in Neurological) 6
Outcome Breakdown
Outcome Unknown
38 (50.7%)
Ongoing
26 (34.7%)
Recovered/Normal
8 (10.7%)
Recovered with Sequela
2 (2.7%)
Died
1 (1.3%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.