Drug profile

The FDA adverse-event record for Ear Cleaner (Unknown)

554 FDA reports name Ear Cleaner (Unknown), a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#281 of 2,679
by report volume (all drugs)
554
adverse-event reports
2.3%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Ear Cleaner (Unknown) ranks #281 of 2679 by total reports (554) and #963 of 1130 by death-coded share (2.3%). 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)
#281
This drug, reports of 2679
#963
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. Ear Cleaner (Unknown) has 554 reports now versus 550 in that prior snapshot: 4 more (0.7%).

Report change
+4
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 Ear Cleaner (Unknown) changes

Signature read: 554 reports place Ear Cleaner (Unknown) in the upper third of FDA AER volume (#281 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
554
Total Reports
13
Deaths Reported
2.3%
Death-coded share of reports

Active Ingredients

Ear Cleaner (Unknown)

Administration Routes

Auricular (Otic)UnknownIntraocularOralOtherTopical

Species Affected

Dog 503
Cat 51

Most Affected Breeds

Retriever - Labrador 75
Retriever - Golden 37
Domestic Shorthair 31
Shih Tzu 30
Shepherd Dog - German 23
Chihuahua 23
Crossbred Canine/dog 22
Pit Bull 17
Terrier - Yorkshire 14
Dog (unknown) 14

Most Reported Reactions

Lack of efficacy - NOS 180
Vomiting 48
Ear discharge 40
Loss of hearing 33
Head tilt - ear disorder 30
Deafness 29
Ataxia 29
Lethargy (see also Central nervous system depression in 'Neurological') 28
Behavioural disorder NOS 25
Not eating 25
Diarrhoea 22
Corneal ulcer 22

Outcome Breakdown

Outcome Unknown
244 (44.0%)
Ongoing
186 (33.6%)
Recovered/Normal
95 (17.1%)
Recovered with Sequela
16 (2.9%)
Euthanized
8 (1.4%)
Died
5 (0.9%)

Ear Cleaner (Unknown): 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 Ear Cleaner (Unknown), both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Ear Cleaner (Unknown)'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 Ear Cleaner (Unknown) (#281 of 2,679 by report volume); death-coded 2.3%. PlainBreed drug row · report volume stamp 554 · 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 →