Drug profile

The FDA adverse-event record for Oclacitinib Maleate

29,264 FDA reports name Oclacitinib Maleate, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#10 of 2,679
by report volume (all drugs)
29,264
adverse-event reports
4.9%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Oclacitinib Maleate ranks #10 of 2679 by total reports (29,264) and #797 of 1130 by death-coded share (4.9%). 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)
#10
This drug, reports of 2679
#797
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. Oclacitinib Maleate has 29,264 reports now versus 28,688 in that prior snapshot: 576 more (2.0%).

Report change
+576
Death-coded reports
+37
Death-coded share
+0.0 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 Oclacitinib Maleate changes

Signature read: 29,264 reports place Oclacitinib Maleate in the upper third of FDA AER volume (#10 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.
29,264
Total Reports
1,424
Deaths Reported
4.9%
Death-coded share of reports

Active Ingredients

Oclacitinib Maleate

Administration Routes

OralUnknownSubcutaneousTopicalOtherOphthalmicParenteralAuricular (Otic)Respiratory (Inhalation)Nasal

Species Affected

Dog 27,646
Unknown 1,015
Cat 431
Human 151
Horse 12
Monkey 2
Lynx 2
Other Canids 1
Donkey 1
Other Mammals 1

Most Affected Breeds

Retriever - Labrador 2,996
Dog (unknown) 1,921
Terrier - Bull - American Pit 1,416
Retriever - Golden 1,352
Shih Tzu 1,211
Unknown 1,180
Shepherd Dog - German 1,172
Terrier - Yorkshire 921
Crossbred Canine/dog 835
Boxer (German Boxer) 764

Most Reported Reactions

Lack of efficacy - NOS 3,664
Vomiting 3,331
INEFFECTIVE, ATOPY CONTROL 2,704
Diarrhoea 2,247
Lethargy (see also Central nervous system depression in 'Neurological') 2,121
INEFFECTIVE, LOSS OF EFFECT 1,806
Other abnormal test result NOS 1,410
Elevated alanine aminotransferase (ALT) 1,150
Seizure NOS 1,113
Elevated serum alkaline phosphatase (SAP) 1,023
Anorexia 940
Leucopenia NOS 877

Outcome Breakdown

Ongoing
16,946 (59.9%)
Outcome Unknown
5,485 (19.4%)
Recovered/Normal
4,378 (15.5%)
Euthanized
790 (2.8%)
Died
636 (2.2%)
Recovered with Sequela
46 (0.2%)

Oclacitinib Maleate: low death-coded share 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 Oclacitinib Maleate, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar death-coded share

Nearest other drugs by death-coded share (4.9% 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 Oclacitinib Maleate (#10 of 2,679 by report volume); death-coded 4.9%. PlainBreed drug row · report volume stamp 29,264 · 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 →