Drug profile

The FDA adverse-event record for Miconazole Nitrate

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

82
adverse-event reports
1.2%
death-coded share
Dog
most-reported species
9
Diarrhoea - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
82
Total Reports
1
Deaths Reported
1.2%
Death Rate

Active Ingredients

Miconazole Nitrate

Administration Routes

UnknownTopicalAuricular (Otic)OralOphthalmic

Species Affected

Dog 37
Unknown 36
Cat 9

Most Affected Breeds

Unknown 40
Retriever - Golden 6
Retriever - Labrador 4
Domestic Shorthair 4
Spitz - German Pomeranian 3
Pug 3
Crossbred Canine/dog 3
Chihuahua 3
Domestic Longhair 2
Mountain Dog - Bernese 2

Most Reported Reactions

Diarrhoea 9
Product Defect, General 8
Vomiting 7
Other abnormal test result NOS 6
Lethargy (see also Central nervous system depression in Neurological) 6
Dermatitis 5
Elevated alanine aminotransferase (ALT) 5
Defect Unknown/Not Specified 4
Hypoproteinaemia 4
Leucopenia NOS 4
Emesis 3
Itching 3

Outcome Breakdown

Ongoing
15 (34.9%)
Recovered/Normal
13 (30.2%)
Outcome Unknown
13 (30.2%)
Recovered with Sequela
1 (2.3%)
Euthanized
1 (2.3%)

Miconazole Nitrate Adverse Event Insights

82 reports name Miconazole Nitrate; 1 recorded a death outcome (1.2% of reported events, not a population-level mortality rate). Active ingredient: Miconazole Nitrate. Administration routes: Unknown, Topical, Auricular (Otic), Oral.

By species: Dog (37 reports), Unknown (36 reports), Cat (9 reports). By breed: Unknown (40), Retriever - Golden (6), Retriever - Labrador (4).

Leading clinical signs: Diarrhoea (9), Product Defect, General (8), Vomiting (7), Other abnormal test result NOS (6). Outcome, 43 coded reports: Ongoing leads at 34.9%.

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.