Drug profile

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

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

311
adverse-event reports
2.6%
death-coded share
Dog
most-reported species
122
Emesis - 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.
311
Total Reports
8
Deaths Reported
2.6%
Death Rate

Active Ingredients

Ear Medication (Unknown)

Administration Routes

Auricular (Otic)UnknownTopicalOralOphthalmicIntraocular

Species Affected

Dog 293
Cat 17
Ferret 1

Most Affected Breeds

Retriever - Labrador 46
Retriever - Golden 22
Shih Tzu 15
Spaniel - Cocker American 14
Domestic Shorthair 13
Crossbred Canine/dog 12
Pug 11
Pit Bull 11
Shepherd Dog - German 10
Beagle 9

Most Reported Reactions

Emesis 122
Vomiting 56
Lethargy (see also Central nervous system depression in 'Neurological') 39
Lack of efficacy - NOS 25
Ear infection NOS 16
Diarrhoea 15
Behavioural disorder NOS 12
Seizure NOS 11
Emesis (multiple) 11
Anorexia 10
Ataxia 10
Lack of efficacy (ectoparasite) - flea 10

Outcome Breakdown

Recovered/Normal
204 (65.6%)
Outcome Unknown
59 (19.0%)
Ongoing
29 (9.3%)
Recovered with Sequela
11 (3.5%)
Died
7 (2.3%)
Euthanized
1 (0.3%)

Ear Medication (Unknown) Adverse Event Insights

311 reports name Ear Medication (Unknown); 8 recorded a death outcome (2.6% of reported events, not a population-level mortality rate). Active ingredient: Ear Medication (Unknown). Administration routes: Auricular (Otic), Unknown, Topical, Oral.

By species: Dog (293 reports), Cat (17 reports), Ferret (1 reports). By breed: Retriever - Labrador (46), Retriever - Golden (22), Shih Tzu (15).

Leading clinical signs: Emesis (122), Vomiting (56), Lethargy (see also Central nervous system depression in 'Neurological') (39), Lack of efficacy - NOS (25). Outcome, 311 coded reports: Recovered/Normal leads at 65.6%.

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.