Fuzapladib Sodium

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327 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.
327
Total Reports
125
Deaths Reported
3820.0%
Death Rate

Active Ingredients

Fuzapladib Sodium

Administration Routes

IntravenousUnknownSubcutaneousParenteralIntradermal

Species Affected

Dog 308
Unknown 15
Cat 2
Human 2

Most Affected Breeds

Crossbred Canine/dog 70
Terrier - Yorkshire 26
Unknown 26
Dog (unknown) 19
Mixed (Dog) 12
Chihuahua 10
Dachshund (unspecified) 10
Shih Tzu 9
Boxer (German Boxer) 7
Retriever - Labrador 5

Most Reported Reactions

Death by euthanasia 81
Lack of efficacy - NOS 45
Vomiting 35
Elevated total bilirubin 34
Abnormal ultrasound finding 31
Anorexia 30
Elevated serum alkaline phosphatase (ALP) 28
Death 28
Lethargy (see also Central nervous system depression in Neurological) 26
Icterus 25
Diarrhoea 24
Neutrophilia 20

Outcome Breakdown

Ongoing
129 (41.3%)
Euthanized
80 (25.6%)
Recovered/Normal
46 (14.7%)
Died
45 (14.4%)
Outcome Unknown
12 (3.8%)

Data Summary

Metric Value
Total adverse event reports 327
Reports involving death 125
Case-fatality rate (reported events) 3820.0%
Distinct species in reports 4
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.

Fuzapladib Sodium Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 327 adverse event reports referencing Fuzapladib Sodium, including 125 reports in which the animal died — a 3820.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fuzapladib Sodium. Reported administration routes include Intravenous, Unknown, Subcutaneous, Parenteral. 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 Fuzapladib Sodium reports are Dog (308 reports), Unknown (15 reports), Cat (2 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (70), Terrier - Yorkshire (26), Unknown (26) 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 Fuzapladib Sodium are Death by euthanasia (81), Lack of efficacy - NOS (45), Vomiting (35), Elevated total bilirubin (34). Of the 312 reports with a coded outcome, Ongoing is the leading category at 41.3%. 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 Fuzapladib Sodium.

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