Drug profile

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

540 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Ear Cleaner (Unknown). See the species affected, top reactions, and outcomes below.

540
adverse-event reports
2.4%
death-coded share
Dog
most-reported species
179
Lack of efficacy - NOS - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
540
Total Reports
13
Deaths Reported
2.4%
Death Rate

Active Ingredients

Ear Cleaner (Unknown)

Administration Routes

Auricular (Otic)UnknownIntraocularOralOtherTopical

Species Affected

Dog 491
Cat 49

Most Affected Breeds

Retriever - Labrador 75
Retriever - Golden 35
Shih Tzu 30
Domestic Shorthair 29
Shepherd Dog - German 23
Chihuahua 23
Crossbred Canine/dog 21
Pit Bull 17
Dog (unknown) 14
Spaniel - Cocker American 13

Most Reported Reactions

Lack of efficacy - NOS 179
Vomiting 47
Ear discharge 39
Loss of hearing 31
Lethargy (see also Central nervous system depression in 'Neurological') 28
Deafness 28
Head tilt - ear disorder 28
Ataxia 28
Behavioural disorder NOS 25
Not eating 25
Diarrhoea 21
Corneal ulcer 21

Outcome Breakdown

Outcome Unknown
241 (44.6%)
Ongoing
177 (32.8%)
Recovered/Normal
93 (17.2%)
Recovered with Sequela
16 (3.0%)
Euthanized
8 (1.5%)
Died
5 (0.9%)

Ear Cleaner (Unknown) Adverse Event Insights

540 reports name Ear Cleaner (Unknown); 13 recorded a death outcome (2.4% of reported events, not a population-level mortality rate). Active ingredient: Ear Cleaner (Unknown). Administration routes: Auricular (Otic), Unknown, Intraocular, Oral.

By species: Dog (491 reports), Cat (49 reports). By breed: Retriever - Labrador (75), Retriever - Golden (35), Shih Tzu (30).

Leading clinical signs: Lack of efficacy - NOS (179), Vomiting (47), Ear discharge (39), Loss of hearing (31). Outcome, 540 coded reports: Outcome Unknown leads at 44.6%.

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.