Drug profile

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

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

#209 of 2,679
by report volume (all drugs)
830
adverse-event reports
1.2%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Miconazole + Polymyxin B + Prednisolone ranks #209 of 2679 by total reports (830) and #1054 of 1130 by death-coded share (1.2%). 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)
#209
This drug, reports of 2679
#1054
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 + Polymyxin B + Prednisolone has 830 reports now versus 817 in that prior snapshot: 13 more (1.6%).

Report change
+13
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 + Polymyxin B + Prednisolone changes

Signature read: 830 reports place Miconazole + Polymyxin B + Prednisolone in the upper third of FDA AER volume (#209 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
830
Total Reports
10
Deaths Reported
1.2%
Death-coded share of reports

Active Ingredients

MiconazolePolymyxin BPrednisolone

Administration Routes

Auricular (Otic)UnknownTopicalOralIntraocularOtherOphthalmicIntra-ArticularNasal

Species Affected

Dog 744
Unknown 56
Cat 26
Human 4

Most Affected Breeds

Retriever - Labrador 69
Unknown 61
Terrier - Yorkshire 48
Dog (unknown) 45
Chihuahua 44
Pug 31
Retriever - Golden 31
Maltese 29
Crossbred Canine/dog 28
Shih Tzu 25

Most Reported Reactions

Loss of hearing 205
Deafness 157
Lack of efficacy - NOS 100
Impaired hearing 80
Hearing decreased 68
Behavioural disorder NOS 39
Vomiting 38
Ear discharge 37
Ear infection NOS 33
Partial deafness 31
Drug administration duration too long 29
Deafness NOS 29

Outcome Breakdown

Ongoing
343 (44.4%)
Outcome Unknown
274 (35.4%)
Recovered/Normal
98 (12.7%)
Recovered with Sequela
48 (6.2%)
Euthanized
6 (0.8%)
Died
4 (0.5%)

Miconazole + Polymyxin B + Prednisolone: 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 + Polymyxin B + Prednisolone, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Miconazole + Polymyxin B + Prednisolone'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 + Polymyxin B + Prednisolone (#209 of 2,679 by report volume); death-coded 1.2%. PlainBreed drug row · report volume stamp 830 · 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 →