Drug profile

The FDA adverse-event record for Miconazole + Polymyxin B + Prednisolone

803 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Miconazole + Polymyxin B + Prednisolone. See the species affected, top reactions, and outcomes below.

803
adverse-event reports
1.2%
death-coded share
Dog
most-reported species
193
Loss of hearing - 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.
803
Total Reports
10
Deaths Reported
1.2%
Death Rate

Active Ingredients

MiconazolePolymyxin BPrednisolone

Administration Routes

Auricular (Otic)UnknownTopicalOralIntraocularOtherOphthalmicIntra-Articular

Species Affected

Dog 719
Unknown 55
Cat 25
Human 4

Most Affected Breeds

Retriever - Labrador 67
Unknown 60
Terrier - Yorkshire 46
Dog (unknown) 45
Chihuahua 42
Pug 31
Retriever - Golden 28
Crossbred Canine/dog 26
Maltese 26
Shih Tzu 24

Most Reported Reactions

Loss of hearing 193
Deafness 155
Lack of efficacy - NOS 100
Impaired hearing 79
Hearing decreased 67
Vomiting 38
Behavioural disorder NOS 38
Ear discharge 36
Partial deafness 31
Ear infection NOS 30
Drug administration duration too long 29
Deafness NOS 28

Outcome Breakdown

Ongoing
333 (44.6%)
Outcome Unknown
262 (35.1%)
Recovered/Normal
94 (12.6%)
Recovered with Sequela
48 (6.4%)
Euthanized
6 (0.8%)
Died
4 (0.5%)

Miconazole + Polymyxin B + Prednisolone Adverse Event Insights

803 reports name Miconazole + Polymyxin B + Prednisolone; 10 recorded a death outcome (1.2% of reported events, not a population-level mortality rate). Active ingredients: Miconazole, Polymyxin B, Prednisolone. Administration routes: Auricular (Otic), Unknown, Topical, Oral.

By species: Dog (719 reports), Unknown (55 reports), Cat (25 reports). By breed: Retriever - Labrador (67), Unknown (60), Terrier - Yorkshire (46).

Leading clinical signs: Loss of hearing (193), Deafness (155), Lack of efficacy - NOS (100), Impaired hearing (79). Outcome, 747 coded reports: Ongoing 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.