Drug profile

The FDA adverse-event record for Unspecified Ear Cleanser

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

49
adverse-event reports
2.0%
death-coded share
Dog
most-reported species
12
Head shake - ear disorder - 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
1
Deaths Reported
2.0%
Death Rate

Active Ingredients

Unspecified Ear Cleanser

Administration Routes

UnknownAuricular (Otic)

Species Affected

Dog 39
Cat 10

Most Affected Breeds

Domestic Shorthair 9
Retriever - Labrador 5
Shepherd Dog - German 3
Shih Tzu 3
Bichon Frise 2
Poodle - Standard 2
Dog (unknown) 2
Retriever - Golden 2
Pug 2
Spaniel (unspecified) 2

Most Reported Reactions

Head shake - ear disorder 12
Lack of efficacy - NOS 12
Lethargy (see also Central nervous system depression in 'Neurological') 8
Ear discharge 8
Ataxia 8
Anorexia 7
Behavioural disorder NOS 5
Otorrhoea 5
Nystagmus 5
Diarrhoea 4
Ear canal inflammation 4
Head tilt - ear disorder 4

Outcome Breakdown

Outcome Unknown
34 (69.4%)
Recovered/Normal
10 (20.4%)
Ongoing
3 (6.1%)
Recovered with Sequela
1 (2.0%)
Died
1 (2.0%)

Unspecified Ear Cleanser Adverse Event Insights

49 reports name Unspecified Ear Cleanser; 1 recorded a death outcome (2.0% of reported events, not a population-level mortality rate). Active ingredient: Unspecified Ear Cleanser. Administration routes: Unknown, Auricular (Otic).

By species: Dog (39 reports), Cat (10 reports). By breed: Domestic Shorthair (9), Retriever - Labrador (5), Shepherd Dog - German (3).

Leading clinical signs: Head shake - ear disorder (12), Lack of efficacy - NOS (12), Lethargy (see also Central nervous system depression in 'Neurological') (8), Ear discharge (8). Outcome, 49 coded reports: Outcome Unknown leads at 69.4%.

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.