Drug profile

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

701 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate. See the species affected, top reactions, and outcomes below.

701
adverse-event reports
0.6%
death-coded share
Unknown
most-reported species
368
Dispenser, Abnormal - 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.
701
Total Reports
4
Deaths Reported
0.6%
Death Rate

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
Lack of efficacy - NOS 11
Lethargy (see also Central nervous system depression in 'Neurological') 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 Adverse Event Insights

701 reports name Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate; 4 recorded a death outcome (0.6% of reported events, not a population-level mortality rate). Active ingredient: Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate. Administration routes: Unknown, Topical, Auricular (Otic), Oral.

By species: Unknown (423 reports), Dog (261 reports), Cat (10 reports). By breed: Unknown (430), Retriever - Labrador (22), Pug (15).

Leading clinical signs: Dispenser, Abnormal (368), Uncoded sign (281), Hearing affected (122), Difficulty of Use (85). Outcome, 280 coded reports: Outcome Unknown leads at 49.3%.

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.