Drug profile

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

112 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.

112
adverse-event reports
0.0%
death-coded share
Unknown
most-reported species
54
Dispenser, Abnormal - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
112
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Gentamicin Sulfate, Hydrocortisone Aceponate, Miconazole Nitrate

Administration Routes

UnknownAuricular (Otic)Oral

Species Affected

Unknown 59
Dog 49
Cat 4

Most Affected Breeds

Unknown 59
Retriever - Labrador 7
Dog (unknown) 5
Poodle - Miniature 3
Terrier - Yorkshire 3
Domestic Shorthair 3
Poodle - Standard 3
Lhasa Apso 3
Maltese 2
Mastiff 2

Most Reported Reactions

Dispenser, Abnormal 54
Uncoded sign 44
Hearing affected 24
Product Defect, General 10
Lack of efficacy - NOS 6
Underfilling, Tubes 4
Pinnal erythema 3
Underfilling, Package 3
Pinnal reddening 3
Pinnal irritation 3
Head shake - ear disorder 3
Vomiting 3

Outcome Breakdown

Recovered/Normal
32 (60.4%)
Outcome Unknown
16 (30.2%)
Recovered with Sequela
5 (9.4%)

Gentamicin Sulfate, Hydrocortisone Aceponate, Miconazole Nitrate Adverse Event Insights

112 reports name Gentamicin Sulfate, Hydrocortisone Aceponate, Miconazole Nitrate; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Gentamicin Sulfate, Hydrocortisone Aceponate, Miconazole Nitrate. Administration routes: Unknown, Auricular (Otic), Oral.

By species: Unknown (59 reports), Dog (49 reports), Cat (4 reports). By breed: Unknown (59), Retriever - Labrador (7), Dog (unknown) (5).

Leading clinical signs: Dispenser, Abnormal (54), Uncoded sign (44), Hearing affected (24), Product Defect, General (10). Outcome, 53 coded reports: Recovered/Normal leads at 60.4%.

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.