Clotrimazole

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20 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.
20
Total Reports
1
Deaths Reported
500.0%
Death Rate

Active Ingredients

Clotrimazole

Administration Routes

UnknownAuricular (Otic)TopicalOralOphthalmicNasal

Species Affected

Dog 15
Cat 5

Most Affected Breeds

Domestic Shorthair 3
Retriever - Labrador 2
Maltese 2
Shih Tzu 2
Boxer (German Boxer) 1
Rottweiler 1
Terrier (unspecified) 1
Domestic Mediumhair 1
Cat (unknown) 1
Spaniel (unspecified) 1

Most Reported Reactions

Lack of efficacy - NOS 6
Licking 3
Loss of hearing 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Elevated alanine aminotransferase (ALT) 2
Decreased appetite 2
Erythema (for urticaria see Immune SOC) 2
Nasal discharge 2
Abnormal cytology 2
Behavioural disorder NOS 2
Head tilt - neurological disorder (see also Head tilt - ear disorder) 2
Vomiting 2

Outcome Breakdown

Outcome Unknown
10 (50.0%)
Ongoing
6 (30.0%)
Recovered/Normal
2 (10.0%)
Euthanized
1 (5.0%)
Recovered with Sequela
1 (5.0%)

Data Summary

Metric Value
Total adverse event reports 20
Reports involving death 1
Case-fatality rate (reported events) 500.0%
Distinct species in reports 2
Distinct breeds in reports 15
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Clotrimazole Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 20 adverse event reports referencing Clotrimazole, including 1 reports in which the animal died — a 500.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Clotrimazole. Reported administration routes include Unknown, Auricular (Otic), Topical, Oral. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Clotrimazole reports are Dog (15 reports), Cat (5 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (3), Retriever - Labrador (2), Maltese (2) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Clotrimazole are Lack of efficacy - NOS (6), Licking (3), Loss of hearing (3), Lethargy (see also Central nervous system depression in 'Neurological') (2). Of the 20 reports with a coded outcome, Outcome Unknown is the leading category at 50.0%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Clotrimazole.

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

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial