Drug profile

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

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

808
adverse-event reports
1.0%
death-coded share
Unknown
most-reported species
228
Difficulty of Use - 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.
808
Total Reports
8
Deaths Reported
1.0%
Death Rate

Active Ingredients

Gentamicin SulfateHydrocortisone AceponateMiconazole Nitrate

Administration Routes

UnknownAuricular (Otic)OralTopicalOtherOphthalmic

Species Affected

Unknown 424
Dog 379
Cat 3
Human 2

Most Affected Breeds

Unknown 426
Retriever - Labrador 45
Dog (unknown) 32
Retriever - Golden 24
Pit Bull 24
Pug 18
Terrier - Yorkshire 18
Shepherd Dog - German 15
Chihuahua 14
Boxer (German Boxer) 13

Most Reported Reactions

Difficulty of Use 228
Loss of hearing 208
Dispenser, Abnormal 203
Product Defect, General 92
Administration device NOS, priming issue 78
Administration device NOS, malfunction 45
Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') 45
Lack of efficacy - NOS 44
Appearance, Abnormal 44
Containers, Damaged 36
Administration device NOS, abnormal 25
Containers, Leaking 22

Outcome Breakdown

Outcome Unknown
256 (66.7%)
Recovered/Normal
103 (26.8%)
Recovered with Sequela
11 (2.9%)
Euthanized
6 (1.6%)
Ongoing
6 (1.6%)
Died
2 (0.5%)

Gentamicin Sulfate + Hydrocortisone Aceponate + Miconazole Nitrate Adverse Event Insights

808 reports name Gentamicin Sulfate + Hydrocortisone Aceponate + Miconazole Nitrate; 8 recorded a death outcome (1.0% of reported events, not a population-level mortality rate). Active ingredients: Gentamicin Sulfate, Hydrocortisone Aceponate, Miconazole Nitrate. Administration routes: Unknown, Auricular (Otic), Oral, Topical.

By species: Unknown (424 reports), Dog (379 reports), Cat (3 reports). By breed: Unknown (426), Retriever - Labrador (45), Dog (unknown) (32).

Leading clinical signs: Difficulty of Use (228), Loss of hearing (208), Dispenser, Abnormal (203), Product Defect, General (92). Outcome, 384 coded reports: Outcome Unknown leads at 66.7%.

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.