Drug profile

The FDA adverse-event record for Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate

701 FDA reports name Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#237 of 2,679
by report volume (all drugs)
701
adverse-event reports
0.6%
death-coded share
Unknown
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate ranks #237 of 2679 by total reports (701) and #1093 of 1130 by death-coded share (0.6%). 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)
#237
This drug, reports of 2679
#1093
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. Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate has 701 reports now versus 701 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 Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate changes

Signature read: 701 reports place Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate in the upper third of FDA AER volume (#237 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.
701
Total Reports
4
Deaths Reported
0.6%
Death-coded share of reports

Active Ingredients

Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate

Administration Routes

UnknownTopicalAuricular (Otic)OralOphthalmicBuccalIrrigation

Species Affected

Unknown 423
Dog 261
Cat 10
Human 7

Most Affected Breeds

Unknown 430
Retriever - Labrador 22
Pug 15
Mixed (Dog) 12
Terrier - Yorkshire 12
Retriever - Golden 12
Boxer (German Boxer) 11
Dog (unknown) 10
Poodle - Toy 10
Maltese 9

Most Reported Reactions

Dispenser, Abnormal 368
Uncoded sign 281
Hearing affected 122
Difficulty of Use 85
Loss of hearing 39
Underfilling, Container 16
Lethargy (see also Central nervous system depression in 'Neurological') 11
Lack of efficacy - NOS 11
Containers, Leaking 11
Application site erythema 10
Vomiting 9
Product Defect, General 8

Outcome Breakdown

Outcome Unknown
138 (49.3%)
Recovered/Normal
116 (41.4%)
Recovered with Sequela
17 (6.1%)
Ongoing
5 (1.8%)
Euthanized
3 (1.1%)
Died
1 (0.4%)

Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate: 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 Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate'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 Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate (#237 of 2,679 by report volume); death-coded 0.6%. PlainBreed drug row · report volume stamp 701 · 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 →