Drug profile

The FDA adverse-event record for Ketoconazole Flush

50 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ketoconazole Flush. Species, reactions, and outcomes follow.

#1125 of 2,679
by report volume (all drugs)
50
adverse-event reports
4.0%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Ketoconazole Flush ranks #1120 of 2679 by total reports (50) and #846 of 1130 by death-coded share (4.0%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#1120
This drug, reports of 2679
#846
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Ketoconazole Flush has 50 reports now versus 50 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
+0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Ketoconazole Flush changes

Signature read: Ketoconazole Flush's 4.0% death-coded share is among the lowest in the openFDA drug corpus.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
50
Total Reports
2
Deaths Reported
4.0%
Death-coded share of reports

Active Ingredients

Ketoconazole Flush

Administration Routes

UnknownAuricular (Otic)Intra-Articular

Species Affected

Dog 42
Cat 8

Most Affected Breeds

Crossbred Canine/dog 7
Retriever - Labrador 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 (72.0%)
Recovered/Normal
9 (18.0%)
Ongoing
2 (4.0%)
Died
1 (2.0%)
Recovered with Sequela
1 (2.0%)
Euthanized
1 (2.0%)

Ketoconazole Flush: low death-coded share in the FDA AER row

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.

Nationwide drugs with similar profiles

Two openFDA-derived peer sets for Ketoconazole Flush, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar death-coded share

Nearest other drugs by death-coded share (4.0% here), distinct from the volume row.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

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

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Ketoconazole Flush (#1125 of 2,679 by report volume); death-coded 4.0%. PlainBreed drug row · death-coded share stamp 4.0% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →