Drug profile

The FDA adverse-event record for Miconazole Nitrate + Polymyxin B Sulfate + Prednisoline Acetate

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

13
adverse-event reports
0.0%
death-coded share
Dog
most-reported species
6
Deafness - 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.
13
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Miconazole NitratePolymyxin B SulfatePrednisoline Acetate

Administration Routes

Auricular (Otic)OphthalmicUnknown

Species Affected

Dog 12
Human 1

Most Affected Breeds

Crossbred Canine/dog 3
Terrier - Yorkshire 2
Unknown 1
Shepherd Dog - German 1
Bichon Frise 1
Pekingese 1
Poodle - Miniature 1
Pinscher - Miniature 1
Lhasa Apso 1
Terrier - Irish Soft-coated Wheaten 1

Most Reported Reactions

Deafness 6
Blindness 2
Loss of hearing 2
Eye pain 1
Double vision 1
Accidental exposure 1
Uveitis 1
Cataract 1
Retinal detachment 1
Impaired hearing 1
Hearing decreased 1
Blue eye 1

Outcome Breakdown

Recovered/Normal
5 (38.5%)
Outcome Unknown
3 (23.1%)
Recovered with Sequela
3 (23.1%)
Ongoing
2 (15.4%)

Miconazole Nitrate + Polymyxin B Sulfate + Prednisoline Acetate Adverse Event Insights

13 reports name Miconazole Nitrate + Polymyxin B Sulfate + Prednisoline Acetate; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredients: Miconazole Nitrate, Polymyxin B Sulfate, Prednisoline Acetate. Administration routes: Auricular (Otic), Ophthalmic, Unknown.

By species: Dog (12 reports), Human (1 reports). By breed: Crossbred Canine/dog (3), Terrier - Yorkshire (2), Unknown (1).

Leading clinical signs: Deafness (6), Blindness (2), Loss of hearing (2), Eye pain (1). Outcome, 13 coded reports: Recovered/Normal leads at 38.5%.

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.