Ketoconazole + Tris-Edta
19 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.
19
Total Reports
3
Deaths Reported
1580.0%
Death Rate
Active Ingredients
KetoconazoleKetoconazole + Tris-EdtaTris-Edta
Administration Routes
UnknownAuricular (Otic)
Species Affected
Dog 17
Cat 2
Most Affected Breeds
Retriever - Labrador 3
Poodle (unspecified) 3
Poodle - Toy 2
Domestic Shorthair 2
Corso Dog 1
Schipperke 1
Shepherd Dog - Australian 1
Bulldog (unspecified) 1
Shepherd Dog (unspecified) 1
Bulldog - American 1
Most Reported Reactions
Lack of efficacy (fungi) - NOS 5
Head tilt - ear disorder 4
Ear canal erythema 3
Tense abdomen 3
Ataxia 3
Balance problem 3
Lack of efficacy - NOS 3
Icterus 2
Other abnormal test result NOS 2
Ear infection NOS 2
Bradycardia 2
Abnormal posture 2
Outcome Breakdown
Outcome Unknown
6 (31.6%)
Recovered/Normal
6 (31.6%)
Ongoing
3 (15.8%)
Euthanized
2 (10.5%)
Recovered with Sequela
1 (5.3%)
Died
1 (5.3%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.