Drug profile

The FDA adverse-event record for Otic Product (Unknown)

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

17
adverse-event reports
5.9%
death-coded share
Dog
most-reported species
3
Lack of efficacy - NOS - 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.
17
Total Reports
1
Deaths Reported
5.9%
Death Rate

Active Ingredients

Otic Product (Unknown)

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 16
Cat 1

Most Affected Breeds

Terrier - Yorkshire 2
Pit Bull 2
Dog (unknown) 2
Retriever - Golden 1
Schnauzer (unspecified) 1
Shepherd Dog - German 1
Terrier - Boston 1
Lhasa Apso 1
Boxer (German Boxer) 1
Crossbred Canine/dog 1

Most Reported Reactions

Lack of efficacy - NOS 3
Hives (see also 'Skin') 2
Skin lesion NOS 2
Head shake - ear disorder 2
Vomiting 2
Bloody diarrhoea 2
Diarrhoea 2
Decreased appetite 2
Lethargy (see also Central nervous system depression in Neurological) 2
Loss of hearing 1
Ear discharge 1
Other ear disorder NOS 1

Outcome Breakdown

Ongoing
9 (52.9%)
Outcome Unknown
4 (23.5%)
Recovered/Normal
2 (11.8%)
Died
1 (5.9%)
Recovered with Sequela
1 (5.9%)

Otic Product (Unknown) Adverse Event Insights

17 reports name Otic Product (Unknown); 1 recorded a death outcome (5.9% of reported events, not a population-level mortality rate). Active ingredient: Otic Product (Unknown). Administration routes: Auricular (Otic), Unknown.

By species: Dog (16 reports), Cat (1 reports). By breed: Terrier - Yorkshire (2), Pit Bull (2), Dog (unknown) (2).

Leading clinical signs: Lack of efficacy - NOS (3), Hives (see also 'Skin') (2), Skin lesion NOS (2), Head shake - ear disorder (2). Outcome, 17 coded reports: Ongoing leads at 52.9%.

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.