Drug profile

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

214 FDA reports name Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#525 of 2,679
by report volume (all drugs)
214
adverse-event reports
1.4%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate ranks #524 of 2679 by total reports (214) and #1038 of 1130 by death-coded share (1.4%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#524
This drug, reports of 2679
#1038
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate has 214 reports now versus 214 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
−0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate changes

Signature read: Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate's 1.4% death-coded share is among the lowest in the openFDA drug corpus.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
214
Total Reports
3
Deaths Reported
1.4%
Death-coded share of reports

Active Ingredients

Miconazole NitratePolymyxin B SulfatePrednisolone Acetate

Administration Routes

Auricular (Otic)OralTopicalUnknownOphthalmicOtherIntraocular

Species Affected

Dog 207
Cat 5
Human 1
Rat 1

Most Affected Breeds

Retriever - Labrador 20
Crossbred Canine/dog 17
Dog (unknown) 15
Shih Tzu 10
Terrier - Yorkshire 9
Terrier - Boston 8
Chihuahua 8
Maltese 6
Pit Bull 6
Boxer (German Boxer) 6

Most Reported Reactions

Deafness 66
Loss of hearing 42
Lack of efficacy - NOS 21
Behavioural disorder NOS 19
Emesis 16
Hearing decreased 15
Impaired hearing 13
Partial deafness 12
Lethargy (see also Central nervous system depression in 'Neurological') 12
Diarrhoea 11
Ear infection NOS 8
Head shake - ear disorder 7

Outcome Breakdown

Recovered/Normal
74 (34.7%)
Outcome Unknown
69 (32.4%)
Recovered with Sequela
59 (27.7%)
Ongoing
8 (3.8%)
Euthanized
2 (0.9%)
Died
1 (0.5%)

Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate: low death-coded share in the FDA AER row

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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate's report volume and death-coded share against similar drugs nationwide. See similar drugs
  • Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
  • Browse the full drug directory to compare report counts across products. All drugs

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate (#525 of 2,679 by report volume); death-coded 1.4%. PlainBreed drug row · death-coded share stamp 1.4% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →