Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate
701 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.
701
Total Reports
4
Deaths Reported
60.0%
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%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.