Drug profile

The FDA adverse-event record for Itraconazole

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

542
adverse-event reports
7.6%
death-coded share
Cat
most-reported species
103
Lack of efficacy - NOS - 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.
542
Total Reports
41
Deaths Reported
7.6%
Death Rate

Active Ingredients

Itraconazole

Administration Routes

OralUnknownTopicalCutaneousIntraocular

Species Affected

Cat 414
Unknown 81
Dog 40
Other Birds 3
Human 2
Monkey 1
Other Reptiles 1

Most Affected Breeds

Domestic Shorthair 224
Unknown 87
Cat (unknown) 75
Domestic Longhair 24
Domestic Mediumhair 18
Persian 17
Siamese 11
Maine Coon 10
Abyssinian cat 5
Shih Tzu 4

Most Reported Reactions

Lack of efficacy - NOS 103
Vomiting 82
Lethargy (see also Central nervous system depression in 'Neurological') 59
Weight loss 56
Not eating 56
Elevated alanine aminotransferase (ALT) 53
Decreased appetite 39
Elevated total bilirubin 38
Elevated liver enzymes 36
Diarrhoea 36
Anorexia 34
Jaundice 26

Outcome Breakdown

Outcome Unknown
203 (43.9%)
Ongoing
134 (29.0%)
Recovered/Normal
80 (17.3%)
Died
21 (4.5%)
Euthanized
20 (4.3%)
Recovered with Sequela
4 (0.9%)

Itraconazole Adverse Event Insights

542 reports name Itraconazole; 41 recorded a death outcome (7.6% of reported events, not a population-level mortality rate). Active ingredient: Itraconazole. Administration routes: Oral, Unknown, Topical, Cutaneous.

By species: Cat (414 reports), Unknown (81 reports), Dog (40 reports). By breed: Domestic Shorthair (224), Unknown (87), Cat (unknown) (75).

Leading clinical signs: Lack of efficacy - NOS (103), Vomiting (82), Lethargy (see also Central nervous system depression in 'Neurological') (59), Weight loss (56). Outcome, 462 coded reports: Outcome Unknown leads at 43.9%.

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.