Drug profile

The FDA adverse-event record for Miconazole

98 FDA reports name Miconazole, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#787 of 2,679
by report volume (all drugs)
98
adverse-event reports
12.2%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Miconazole ranks #784 of 2679 by total reports (98) and #450 of 1130 by death-coded share (12.2%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#784
This drug, reports of 2679
#450
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Miconazole has 98 reports now versus 96 in that prior snapshot: 2 more (2.1%).

Report change
+2
Death-coded reports
+1
Death-coded share
+0.8 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Miconazole changes

Signature read: 98 reports place Miconazole in the upper third of FDA AER volume (#787 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
98
Total Reports
12
Deaths Reported
12.2%
Death-coded share of reports

Active Ingredients

Miconazole

Administration Routes

TopicalUnknownAuricular (Otic)Other

Species Affected

Dog 89
Cat 8
Horse 1

Most Affected Breeds

Shih Tzu 9
Terrier - Yorkshire 7
Retriever - Labrador 7
Domestic Shorthair 6
Shepherd Dog - German 5
Boxer (German Boxer) 4
Bulldog 3
Poodle - Miniature 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 (63.3%)
Recovered/Normal
13 (13.3%)
Outcome Unknown
11 (11.2%)
Euthanized
6 (6.1%)
Died
6 (6.1%)

Miconazole: high report volume in the FDA AER row

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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Miconazole, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

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

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Miconazole (#787 of 2,679 by report volume); death-coded 12.2%. PlainBreed drug row · report volume stamp 98 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →