Drug profile

The FDA adverse-event record for Ketoconazole Flush

49 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ketoconazole Flush. See the species affected, top reactions, and outcomes below.

49
adverse-event reports
4.1%
death-coded share
Dog
most-reported species
15
Lack of efficacy - NOS - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
49
Total Reports
2
Deaths Reported
4.1%
Death Rate

Active Ingredients

Ketoconazole Flush

Administration Routes

UnknownAuricular (Otic)Intra-Articular

Species Affected

Dog 41
Cat 8

Most Affected Breeds

Retriever - Labrador 6
Crossbred Canine/dog 6
Retriever - Golden 4
Domestic Shorthair 4
Terrier - Yorkshire 2
Poodle - Standard 2
Dog (unknown) 2
Domestic Mediumhair 2
Pit Bull 2
Rottweiler 1

Most Reported Reactions

Lack of efficacy - NOS 15
Otorrhoea 10
Ataxia 9
Ear infection NOS 7
Head tilt - ear disorder 7
Head shake - ear disorder 6
Ear discharge 5
Deafness 5
Lethargy (see also Central nervous system depression in 'Neurological') 5
Horner's syndrome 5
Ear pruritus 5
Keratoconjunctivitis sicca 4

Outcome Breakdown

Outcome Unknown
36 (73.5%)
Recovered/Normal
9 (18.4%)
Died
1 (2.0%)
Euthanized
1 (2.0%)
Recovered with Sequela
1 (2.0%)
Ongoing
1 (2.0%)

Ketoconazole Flush Adverse Event Insights

49 reports name Ketoconazole Flush; 2 recorded a death outcome (4.1% of reported events, not a population-level mortality rate). Active ingredient: Ketoconazole Flush. Administration routes: Unknown, Auricular (Otic), Intra-Articular.

By species: Dog (41 reports), Cat (8 reports). By breed: Retriever - Labrador (6), Crossbred Canine/dog (6), Retriever - Golden (4).

Leading clinical signs: Lack of efficacy - NOS (15), Otorrhoea (10), Ataxia (9), Ear infection NOS (7). Outcome, 49 coded reports: Outcome Unknown leads at 73.5%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.