Drug profile

The FDA adverse-event record for Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate

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

28
adverse-event reports
17.9%
death-coded share
Dog
most-reported species
8
Vomiting - 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.
28
Total Reports
5
Deaths Reported
17.9%
Death Rate

Active Ingredients

Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate

Administration Routes

Auricular (Otic)UnknownTopical

Species Affected

Dog 27
Rabbit 1

Most Affected Breeds

Retriever - Labrador 3
Siberian Husky 3
Terrier - Yorkshire 3
Shih Tzu 2
Boxer (German Boxer) 2
Bulldog - French 2
Retriever - Golden 2
Collie - Border 1
Saint Bernard Dog 1
Lhasa Apso 1

Most Reported Reactions

Vomiting 8
Lethargy (see also Central nervous system depression in 'Neurological') 6
Panting 5
Diarrhoea 5
Decreased appetite 4
Ear infection NOS 3
Scratching 3
Death 2
Shaking 2
Not eating 2
Pacing 2
Elevated serum alkaline phosphatase (SAP) 2

Outcome Breakdown

Ongoing
13 (46.4%)
Recovered/Normal
8 (28.6%)
Died
3 (10.7%)
Euthanized
2 (7.1%)
Outcome Unknown
2 (7.1%)

Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate Adverse Event Insights

28 reports name Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate; 5 recorded a death outcome (17.9% of reported events, not a population-level mortality rate). Active ingredient: Miconazole Nitrate, Polymyxin B Sulfate, Prednisolone Acetate. Administration routes: Auricular (Otic), Unknown, Topical.

By species: Dog (27 reports), Rabbit (1 reports). By breed: Retriever - Labrador (3), Siberian Husky (3), Terrier - Yorkshire (3).

Leading clinical signs: Vomiting (8), Lethargy (see also Central nervous system depression in 'Neurological') (6), Panting (5), Diarrhoea (5). Outcome, 28 coded reports: Ongoing leads at 46.4%.

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.