Miconazole Nitrate + Polymyxin B Sulfate + Prednisolone Acetate
214 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.
214
Total Reports
3
Deaths Reported
140.0%
Death Rate
Active Ingredients
Miconazole NitratePolymyxin B SulfatePrednisolone Acetate
Administration Routes
Auricular (Otic)OralTopicalUnknownOphthalmicOtherIntraocular
Species Affected
Dog 207
Cat 5
Human 1
Rat 1
Most Affected Breeds
Retriever - Labrador 20
Crossbred Canine/dog 17
Dog (unknown) 15
Shih Tzu 10
Terrier - Yorkshire 9
Terrier - Boston 8
Chihuahua 8
Maltese 6
Pit Bull 6
Boxer (German Boxer) 6
Most Reported Reactions
Deafness 66
Loss of hearing 42
Lack of efficacy - NOS 21
Behavioural disorder NOS 19
Emesis 16
Hearing decreased 15
Impaired hearing 13
Partial deafness 12
Lethargy (see also Central nervous system depression in 'Neurological') 12
Diarrhoea 11
Ear infection NOS 8
Head shake - ear disorder 7
Outcome Breakdown
Recovered/Normal
74 (34.7%)
Outcome Unknown
69 (32.4%)
Recovered with Sequela
59 (27.7%)
Ongoing
8 (3.8%)
Euthanized
2 (0.9%)
Died
1 (0.5%)
Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.