Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate

18 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.
18
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Miconazole Nitrate; Polymyxin B Sulphate; Prednisolone Acetate

Administration Routes

Auricular (Otic)UnknownTopicalIntraocular

Species Affected

Dog 17
Cat 1

Most Affected Breeds

Shepherd Dog - Australian 2
Chihuahua 2
Shih Tzu 1
Poodle - Standard 1
Beagle 1
Bulldog - French 1
Pug 1
Boxer (German Boxer) 1
Pointing Dog - Hungarian Short-haired (Vizsla) 1
Retriever - Labrador 1

Most Reported Reactions

Lack of efficacy - NOS 3
Impaired hearing 3
Anaemia NOS 2
Not eating 2
Otorrhoea 2
Ear discharge 2
Other ear disorder NOS 2
Abnormal cytology 2
Loss of hearing 2
Other abnormal test result NOS 2
Deafness 2
Ear pruritus 2

Outcome Breakdown

Outcome Unknown
9 (50.0%)
Ongoing
7 (38.9%)
Recovered/Normal
2 (11.1%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.