Ketoconazole/Tromethamine/Disodium Edta Dihydrate
36 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.
36
Total Reports
1
Deaths Reported
280.0%
Death Rate
Active Ingredients
Ketoconazole/Tromethamine/Disodium Edta Dihydrate
Administration Routes
UnknownTopical
Species Affected
Dog 32
Cat 4
Most Affected Breeds
Pug 4
Domestic Shorthair 4
Shepherd Dog - German 3
Shih Tzu 3
Retriever - Labrador 3
Spaniel - Cocker American 2
Dog (unknown) 2
Crossbred Canine/dog 2
Spaniel - King Charles Cavalier 2
Bulldog 2
Most Reported Reactions
Lack of efficacy - NOS 11
Ataxia 8
Head tilt - ear disorder 6
Nystagmus 6
Vomiting 5
Ear discharge 5
Emesis (multiple) 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Erythema (for urticaria see Immune SOC) 3
Ear pruritus 3
Head shake - ear disorder 3
Anorexia 3
Outcome Breakdown
Outcome Unknown
20 (55.6%)
Recovered/Normal
15 (41.7%)
Euthanized
1 (2.8%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.