Miconazole + Polymyxin B + Prednisolone
803 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.
803
Total Reports
10
Deaths Reported
120.0%
Death Rate
Active Ingredients
MiconazolePolymyxin BPrednisolone
Administration Routes
Auricular (Otic)UnknownTopicalOralIntraocularOtherOphthalmicIntra-Articular
Species Affected
Dog 719
Unknown 55
Cat 25
Human 4
Most Affected Breeds
Retriever - Labrador 67
Unknown 60
Terrier - Yorkshire 46
Dog (unknown) 45
Chihuahua 42
Pug 31
Retriever - Golden 28
Crossbred Canine/dog 26
Maltese 26
Shih Tzu 24
Most Reported Reactions
Loss of hearing 193
Deafness 155
Lack of efficacy - NOS 100
Impaired hearing 79
Hearing decreased 67
Vomiting 38
Behavioural disorder NOS 38
Ear discharge 36
Partial deafness 31
Ear infection NOS 30
Drug administration duration too long 29
Deafness NOS 28
Outcome Breakdown
Ongoing
333 (44.6%)
Outcome Unknown
262 (35.1%)
Recovered/Normal
94 (12.6%)
Recovered with Sequela
48 (6.4%)
Euthanized
6 (0.8%)
Died
4 (0.5%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.