Drug profile

The FDA adverse-event record for Trizedta/Ketoconazole Ear Product

117 FDA reports name Trizedta/Ketoconazole Ear Product, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#723 of 2,679
by report volume (all drugs)
117
adverse-event reports
1.7%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Trizedta/Ketoconazole Ear Product ranks #717 of 2679 by total reports (117) and #1012 of 1130 by death-coded share (1.7%). 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)
#717
This drug, reports of 2679
#1012
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. Trizedta/Ketoconazole Ear Product has 117 reports now versus 114 in that prior snapshot: 3 more (2.6%).

Report change
+3
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 Trizedta/Ketoconazole Ear Product changes

Signature read: Trizedta/Ketoconazole Ear Product's 1.7% 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.
117
Total Reports
2
Deaths Reported
1.7%
Death-coded share of reports

Active Ingredients

Trizedta/Ketoconazole Ear Product

Administration Routes

Auricular (Otic)UnknownTopicalOralOther

Species Affected

Dog 106
Cat 11

Most Affected Breeds

Retriever - Labrador 18
Shih Tzu 8
Boxer (German Boxer) 6
Spaniel - Cocker American 5
Retriever - Golden 5
Shepherd Dog - German 4
Domestic Shorthair 4
Chihuahua 4
Cat (unknown) 4
Terrier (unspecified) 4

Most Reported Reactions

Lack of efficacy - NOS 21
Ataxia 13
Vomiting 12
Loss of hearing 12
Lethargy (see also Central nervous system depression in 'Neurological') 10
Nystagmus 10
Head tilt - ear disorder 10
Head shake - ear disorder 9
Not eating 8
Other abnormal test result NOS 7
Diarrhoea 6
Ear infection NOS 6

Outcome Breakdown

Outcome Unknown
49 (41.9%)
Ongoing
39 (33.3%)
Recovered/Normal
23 (19.7%)
Recovered with Sequela
4 (3.4%)
Euthanized
1 (0.9%)
Died
1 (0.9%)

Trizedta/Ketoconazole Ear Product: 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.

High-volume nationwide drug peers

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

What to do with this drug

  • Compare Trizedta/Ketoconazole Ear Product's report volume and death-coded share against similar drugs nationwide. See similar drugs
  • Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
  • Browse the full drug directory to compare report counts across products. All drugs

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 Trizedta/Ketoconazole Ear Product (#723 of 2,679 by report volume); death-coded 1.7%. PlainBreed drug row · death-coded share stamp 1.7% · 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 →