Drug profile

The FDA adverse-event record for Oclacitinib Maleate

27,759 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Oclacitinib Maleate. See the species affected, top reactions, and outcomes below.

27,759
adverse-event reports
4.8%
death-coded share
Dog
most-reported species
3,332
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.
27,759
Total Reports
1,327
Deaths Reported
4.8%
Death Rate

Active Ingredients

Oclacitinib Maleate

Administration Routes

OralUnknownSubcutaneousTopicalOtherOphthalmicParenteralAuricular (Otic)Respiratory (Inhalation)Nasal

Species Affected

Dog 26,292
Unknown 953
Cat 347
Human 148
Horse 11
Monkey 2
Lynx 2
Other Canids 1
Donkey 1
Other Mammals 1

Most Affected Breeds

Retriever - Labrador 2,842
Dog (unknown) 1,852
Terrier - Bull - American Pit 1,331
Retriever - Golden 1,263
Shih Tzu 1,166
Unknown 1,115
Shepherd Dog - German 1,105
Terrier - Yorkshire 892
Crossbred Canine/dog 746
Boxer (German Boxer) 732

Most Reported Reactions

Lack of efficacy - NOS 3,332
Vomiting 3,169
INEFFECTIVE, ATOPY CONTROL 2,700
Diarrhoea 2,134
Lethargy (see also Central nervous system depression in 'Neurological') 2,121
INEFFECTIVE, LOSS OF EFFECT 1,805
Other abnormal test result NOS 1,363
Seizure NOS 1,077
Elevated alanine aminotransferase (ALT) 1,076
Elevated serum alkaline phosphatase (SAP) 1,023
Anorexia 912
Leucopenia NOS 842

Outcome Breakdown

Ongoing
16,190 (60.3%)
Outcome Unknown
5,099 (19.0%)
Recovered/Normal
4,174 (15.6%)
Euthanized
737 (2.7%)
Died
592 (2.2%)
Recovered with Sequela
44 (0.2%)

Oclacitinib Maleate Adverse Event Insights

27,759 reports name Oclacitinib Maleate; 1,327 recorded a death outcome (4.8% of reported events, not a population-level mortality rate). Active ingredient: Oclacitinib Maleate. Administration routes: Oral, Unknown, Subcutaneous, Topical.

By species: Dog (26,292 reports), Unknown (953 reports), Cat (347 reports). By breed: Retriever - Labrador (2,842), Dog (unknown) (1,852), Terrier - Bull - American Pit (1,331).

Leading clinical signs: Lack of efficacy - NOS (3,332), Vomiting (3,169), INEFFECTIVE, ATOPY CONTROL (2,700), Diarrhoea (2,134). Outcome, 26,836 coded reports: Ongoing leads at 60.3%.

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.