Gentamicin Sulfate + Hydrocortisone Aceponate + Miconazole Nitrate
808 adverse event reports submitted to the FDA
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
100.0%
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%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.