Drug profile

The FDA adverse-event record for Fluconazole

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

300
adverse-event reports
12.3%
death-coded share
Dog
most-reported species
57
Vomiting - 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.
300
Total Reports
37
Deaths Reported
12.3%
Death Rate

Active Ingredients

Fluconazole

Administration Routes

UnknownOralTopicalIntravenousSubcutaneous

Species Affected

Dog 270
Cat 27
Parrot 2
Human 1

Most Affected Breeds

Retriever - Labrador 29
Shepherd Dog - German 18
Domestic Shorthair 17
Shih Tzu 13
Terrier - Yorkshire 12
Retriever - Golden 12
Terrier - West Highland White 12
Crossbred Canine/dog 10
Pug 8
Bulldog - French 8

Most Reported Reactions

Vomiting 57
Lethargy (see also Central nervous system depression in 'Neurological') 48
Other abnormal test result NOS 39
Diarrhoea 33
Lack of efficacy - NOS 31
Anorexia 20
Weight loss 20
Emesis 19
Death by euthanasia 19
Elevated alanine aminotransferase (ALT) 18
Seizure NOS 18
Death 17

Outcome Breakdown

Ongoing
126 (42.3%)
Recovered/Normal
70 (23.5%)
Outcome Unknown
62 (20.8%)
Died
19 (6.4%)
Euthanized
18 (6.0%)
Recovered with Sequela
3 (1.0%)

Fluconazole Adverse Event Insights

300 reports name Fluconazole; 37 recorded a death outcome (12.3% of reported events, not a population-level mortality rate). Active ingredient: Fluconazole. Administration routes: Unknown, Oral, Topical, Intravenous.

By species: Dog (270 reports), Cat (27 reports), Parrot (2 reports). By breed: Retriever - Labrador (29), Shepherd Dog - German (18), Domestic Shorthair (17).

Leading clinical signs: Vomiting (57), Lethargy (see also Central nervous system depression in 'Neurological') (48), Other abnormal test result NOS (39), Diarrhoea (33). Outcome, 298 coded reports: Ongoing leads at 42.3%.

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.