Drug profile

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

Name: Hydrocortisone Aceponate + Miconazole Nitrate + Gentamicin Sulfate - FDA Animal Adverse Event Reports
Creator: PlainBreed
License: https://creativecommons.org/publicdomain/zero/1.0/

34 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Hydrocortisone Aceponate + Miconazole Nitrate + Gentamicin Sulfate. Species, reactions, and outcomes follow.

#1358 of 2,679
by report volume (all drugs): 34
adverse-event reports: 11.8%
death-coded share: Dog
most-reported species

Compiled by PlainBreed

Verify with FDA CVM →

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Hydrocortisone Aceponate + Miconazole Nitrate + Gentamicin Sulfate ranks #1344 of 2679 by total reports (34). Death-coded-share rank requires at least 50 reports. 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): #1344
This drug, reports of 2679

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 34 reports now versus 32 in that prior snapshot: 2 more (6.3%).

Report change: +2
Death-coded reports: +1
Death-coded share: +2.4 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.

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Signature read: death-coded share at 11.8% is the most distinctive stamp on Hydrocortisone Aceponate + Miconazole Nitrate + Gentamicin Sulfate's FDA AER row.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.

Total Reports

Deaths Reported

11.8%

Death-coded share of reports

Active Ingredients

Hydrocortisone Aceponate + Miconazole Nitrate + Gentamicin Sulfate

Administration Routes

Auricular (Otic)Unknown

Species Affected

Dog 34

Most Affected Breeds

Retriever - Labrador 6

Retriever - Golden 3

Shih Tzu 3

Pinscher - Miniature 3

Dog (unknown) 2

Bulldog - English 2

Bichon Frise 1

Terrier - Jack Russell 1

Bulldog - French 1

Spaniel - Cocker American 1

Most Reported Reactions

Emesis 9

Lethargy (see also Central nervous system depression in Neurological) 9

Diarrhoea 8

Vomiting 7

Other abnormal test result NOS 6

Lack of efficacy - NOS 5

Inappetence 5

Abnormal radiograph finding 4

Trembling 4

Ear infection NOS 4

Pruritus 4

Otitis externa 4

Outcome Breakdown

Recovered/Normal

14 (41.2%)

Outcome Unknown

11 (32.4%)

Ongoing

3 (8.8%)

Died

3 (8.8%)

Recovered with Sequela

2 (5.9%)

Euthanized

1 (2.9%)

Hydrocortisone Aceponate + Miconazole Nitrate + Gentamicin Sulfate Adverse Event Insights

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.

What to do with this drug

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 (#1358 of 2,679 by report volume); death-coded 11.8%. PlainBreed drug row · death-coded share stamp 11.8% · 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 →