Oclacitinib Maleate

27,759 adverse event reports submitted to the FDA

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

480.0%

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%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.