Drug profile

The FDA adverse-event record for Itraconazole

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

#275 of 2,679
by report volume (all drugs)
573
adverse-event reports
7.3%
death-coded share
Cat
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Itraconazole ranks #275 of 2679 by total reports (573) and #678 of 1130 by death-coded share (7.3%). 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)
#275
This drug, reports of 2679
#678
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. Itraconazole has 573 reports now versus 565 in that prior snapshot: 8 more (1.4%).

Report change
+8
Death-coded reports
+0
Death-coded share
−0.1 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 Itraconazole changes

Signature read: 573 reports place Itraconazole in the upper third of FDA AER volume (#275 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.
573
Total Reports
42
Deaths Reported
7.3%
Death-coded share of reports

Active Ingredients

Itraconazole

Administration Routes

OralUnknownTopicalOphthalmicCutaneousIntraocular

Species Affected

Cat 432
Unknown 90
Dog 43
Other Birds 3
Human 2
Monkey 1
Other Reptiles 1
Goat 1

Most Affected Breeds

Domestic Shorthair 232
Unknown 97
Cat (unknown) 76
Domestic Longhair 26
Domestic Mediumhair 20
Persian 20
Siamese 12
Maine Coon 10
Abyssinian cat 5
Shih Tzu 4

Most Reported Reactions

Lack of efficacy - NOS 104
Vomiting 86
Weight loss 59
Lethargy (see also Central nervous system depression in 'Neurological') 59
Not eating 58
Elevated alanine aminotransferase (ALT) 55
Decreased appetite 44
Elevated total bilirubin 40
Diarrhoea 37
Elevated liver enzymes 36
Anorexia 34
Jaundice 28

Outcome Breakdown

Outcome Unknown
216 (44.6%)
Ongoing
136 (28.1%)
Recovered/Normal
86 (17.8%)
Euthanized
21 (4.3%)
Died
21 (4.3%)
Recovered with Sequela
4 (0.8%)

Itraconazole: 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 Itraconazole, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar death-coded share

Nearest other drugs by death-coded share (7.3% here), distinct from the volume row.

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 Itraconazole (#275 of 2,679 by report volume); death-coded 7.3%. PlainBreed drug row · report volume stamp 573 · 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 →