Drug profile

The FDA adverse-event record for Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate

18 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate. See the species affected, top reactions, and outcomes below.

18
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
3
Lack of efficacy - NOS - 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.
18
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate

Administration Routes

Auricular (Otic)UnknownTopicalIntraocular

Species Affected

Dog 17
Cat 1

Most Affected Breeds

Shepherd Dog - Australian 2
Chihuahua 2
Shih Tzu 1
Poodle - Standard 1
Beagle 1
Bulldog - French 1
Pug 1
Boxer (German Boxer) 1
Pointing Dog - Hungarian Short-haired (Vizsla) 1
Retriever - Labrador 1

Most Reported Reactions

Lack of efficacy - NOS 3
Impaired hearing 3
Anaemia NOS 2
Not eating 2
Otorrhoea 2
Ear discharge 2
Other ear disorder NOS 2
Abnormal cytology 2
Loss of hearing 2
Other abnormal test result NOS 2
Deafness 2
Ear pruritus 2

Outcome Breakdown

Outcome Unknown
9 (50.0%)
Ongoing
7 (38.9%)
Recovered/Normal
2 (11.1%)

Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate Adverse Event Insights

18 reports name Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate. Administration routes: Auricular (Otic), Unknown, Topical, Intraocular.

By species: Dog (17 reports), Cat (1 reports). By breed: Shepherd Dog - Australian (2), Chihuahua (2), Shih Tzu (1).

Leading clinical signs: Lack of efficacy - NOS (3), Impaired hearing (3), Anaemia NOS (2), Not eating (2). Outcome, 18 coded reports: Outcome Unknown leads at 50.0%.

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.