Drug profile

The FDA adverse-event record for Miconazole

97 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Miconazole. See the species affected, top reactions, and outcomes below.

97
adverse-event reports
11.3%
death-coded share
Dog
most-reported species
18
Other abnormal test result NOS - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
97
Total Reports
11
Deaths Reported
11.3%
Death Rate

Active Ingredients

Miconazole

Administration Routes

TopicalUnknownAuricular (Otic)Other

Species Affected

Dog 89
Cat 7
Horse 1

Most Affected Breeds

Shih Tzu 9
Terrier - Yorkshire 7
Retriever - Labrador 7
Domestic Shorthair 5
Shepherd Dog - German 5
Boxer (German Boxer) 4
Poodle - Miniature 3
Bulldog 3
Spaniel - Cocker American 3
Pug 3

Most Reported Reactions

Other abnormal test result NOS 18
Lethargy (see also Central nervous system depression in 'Neurological') 14
INEFFECTIVE, ATOPY CONTROL 13
Lack of efficacy - NOS 10
Skin lesion NOS 8
Seizure NOS 8
Skin disorders NOS 7
Anorexia 7
Vomiting 7
Death by euthanasia 6
INEFFECTIVE, LOSS OF EFFECT 6
Pruritus 6

Outcome Breakdown

Ongoing
62 (63.9%)
Recovered/Normal
13 (13.4%)
Outcome Unknown
11 (11.3%)
Euthanized
6 (6.2%)
Died
5 (5.2%)

Miconazole Adverse Event Insights

97 reports name Miconazole; 11 recorded a death outcome (11.3% of reported events, not a population-level mortality rate). Active ingredient: Miconazole. Administration routes: Topical, Unknown, Auricular (Otic), Other.

By species: Dog (89 reports), Cat (7 reports), Horse (1 reports). By breed: Shih Tzu (9), Terrier - Yorkshire (7), Retriever - Labrador (7).

Leading clinical signs: Other abnormal test result NOS (18), Lethargy (see also Central nervous system depression in 'Neurological') (14), INEFFECTIVE, ATOPY CONTROL (13), Lack of efficacy - NOS (10). Outcome, 97 coded reports: Ongoing leads at 63.9%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.