Ketoconazole
1,317 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.
1,317
Total Reports
78
Deaths Reported
590.0%
Death Rate
Active Ingredients
Ketoconazole
Administration Routes
OralUnknownAuricular (Otic)TopicalOphthalmicNasalParenteral
Species Affected
Dog 1,304
Cat 11
Human 2
Most Affected Breeds
Retriever - Labrador 171
Shepherd Dog - German 92
Retriever - Golden 68
Shih Tzu 64
Terrier - West Highland White 49
Crossbred Canine/dog 48
Pit Bull 47
Bulldog 44
Boxer (German Boxer) 39
Terrier - Bull - American Pit 37
Most Reported Reactions
Vomiting 178
Lack of efficacy - NOS 154
Other abnormal test result NOS 146
Diarrhoea 136
Lethargy (see also Central nervous system depression in 'Neurological') 127
Emesis 124
INEFFECTIVE, ATOPY CONTROL 75
Weight loss 71
Anorexia 60
Gingival hyperplasia 55
Ataxia 48
Decreased appetite 48
Outcome Breakdown
Ongoing
531 (40.3%)
Recovered/Normal
398 (30.2%)
Outcome Unknown
277 (21.0%)
Euthanized
46 (3.5%)
Recovered with Sequela
34 (2.6%)
Died
32 (2.4%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.