Ilunocitinib

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897 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.
897
Total Reports
54
Deaths Reported
600.0%
Death Rate

Active Ingredients

Ilunocitinib

Administration Routes

OralUnknown

Species Affected

Dog 870
Unknown 26
Human 1

Most Affected Breeds

Retriever - Labrador 118
Dog (unknown) 82
Pit Bull 61
Retriever - Golden 45
Crossbred Canine/dog 44
Shepherd Dog - German 42
Bulldog - French 37
Shih Tzu 31
Bulldog - English 28
Unknown 27

Most Reported Reactions

Lack of efficacy - NOS 173
Lethargy (see also Central nervous system depression in Neurological) 131
Diarrhoea 110
Vomiting 91
Leucopenia NOS 69
Neutropenia 66
Decreased haematocrit 62
Elevated serum alkaline phosphatase (ALP) 55
Lymphopenia 51
Elevated alanine aminotransferase (ALT) 50
Other abnormal test result NOS 46
Behavioural disorder NOS 45

Outcome Breakdown

Outcome Unknown
386 (44.3%)
Ongoing
271 (31.1%)
Recovered/Normal
160 (18.4%)
Euthanized
39 (4.5%)
Died
15 (1.7%)

Data Summary

Metric Value
Total adverse event reports 897
Reports involving death 54
Case-fatality rate (reported events) 600.0%
Distinct species in reports 3
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Ilunocitinib Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 897 adverse event reports referencing Ilunocitinib, including 54 reports in which the animal died — a 600.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Ilunocitinib. Reported administration routes include Oral, Unknown. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Ilunocitinib reports are Dog (870 reports), Unknown (26 reports), Human (1 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (118), Dog (unknown) (82), Pit Bull (61) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Ilunocitinib are Lack of efficacy - NOS (173), Lethargy (see also Central nervous system depression in Neurological) (131), Diarrhoea (110), Vomiting (91). Of the 871 reports with a coded outcome, Outcome Unknown is the leading category at 44.3%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Ilunocitinib.

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

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial