Drug profile

The FDA adverse-event record for Otomax

19 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Otomax. See the species affected, top reactions, and outcomes below.

19
adverse-event reports
15.8%
death-coded share
Dog
most-reported species
4
Crust - 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.
19
Total Reports
3
Deaths Reported
15.8%
Death Rate

Active Ingredients

Otomax

Administration Routes

Auricular (Otic)TopicalOralUnknown

Species Affected

Dog 16
Cat 3

Most Affected Breeds

Retriever - Labrador 3
Bulldog - French 3
Domestic Longhair 2
Shepherd Dog - German 2
Griffon - French Wire-haired Pointing 2
Dog (other) 1
Spaniel (unspecified) 1
Crossbred Canine/dog 1
Terrier - Bull - American Pit 1
Domestic Shorthair 1

Most Reported Reactions

Crust 4
Leucocytosis NOS 3
Reddening of the skin 3
Emesis (multiple) 3
Anaphylaxis 3
Death by euthanasia 3
Seizure NOS 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Collapse NOS (see also 'Cardio-vascular' and 'Neurological disorders') 2
Laboured breathing 2
Not eating 2
Alopecia 2

Outcome Breakdown

Ongoing
10 (52.6%)
Recovered/Normal
3 (15.8%)
Euthanized
3 (15.8%)
Outcome Unknown
2 (10.5%)
Recovered with Sequela
1 (5.3%)

Otomax Adverse Event Insights

19 reports name Otomax; 3 recorded a death outcome (15.8% of reported events, not a population-level mortality rate). Active ingredient: Otomax. Administration routes: Auricular (Otic), Topical, Oral, Unknown.

By species: Dog (16 reports), Cat (3 reports). By breed: Retriever - Labrador (3), Bulldog - French (3), Domestic Longhair (2).

Leading clinical signs: Crust (4), Leucocytosis NOS (3), Reddening of the skin (3), Emesis (multiple) (3). Outcome, 19 coded reports: Ongoing leads at 52.6%.

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.