Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate

703 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.

703

Total Reports

Deaths Reported

170.0%

Death Rate

Active Ingredients

Clotrimazole, Gentamicin Sulfate, Mometasone Furoate Monohydrate

Administration Routes

Auricular (Otic)TopicalUnknownOralOphthalmicVaginalSubcutaneous

Species Affected

Dog 588

Unknown 93

Cat 17

Human 4

Camel 1

Most Affected Breeds

Unknown 97

Crossbred Canine/dog 88

Retriever - Labrador 54

Terrier - Yorkshire 33

Pug 31

Retriever - Golden 25

Maltese 23

Shih Tzu 22

Boxer (German Boxer) 18

Poodle (unspecified) 17

Most Reported Reactions

Deafness 393

Partial deafness 101

Accidental exposure 36

Missing Cap 34

Vomiting 26

Depression 24

Pinnal erythema 15

Head tilt - ear disorder 15

Lack of efficacy - NOS 13

Pruritus 13

Underfilling, Package 13

Applicator, Abnormal 12

Outcome Breakdown

Recovered with Sequela

20 (32.8%)

Outcome Unknown

15 (24.6%)

Recovered/Normal

13 (21.3%)

Died

12 (19.7%)

Ongoing

1 (1.6%)

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