[No Api/Abi]

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32 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.
32
Total Reports
5
Deaths Reported
1560.0%
Death Rate

Active Ingredients

[No Api/Abi]

Administration Routes

OralUnknown

Species Affected

Dog 19
Cat 12
Unknown 1

Most Affected Breeds

Domestic Shorthair 9
Retriever - Labrador 3
Poodle (unspecified) 2
Retriever - Golden 2
Chihuahua 2
Pug 1
Unknown 1
Poodle - Toy 1
Hound - Basset 1
Shepherd Dog - German 1

Most Reported Reactions

Lack of efficacy (endoparasite) - heartworm 8
Weight loss 7
Anaemia NOS 6
Anorexia 4
Other abnormal test result NOS 4
Lethargy (see also Central nervous system depression in 'Neurological') 3
Death 3
Elevated symmetrical dimethylarginine (SDMA) 3
Abnormal cytology 3
Vomiting 3
Bacterial skin infection NOS 3
Seizure NOS 2

Outcome Breakdown

Ongoing
20 (64.5%)
Outcome Unknown
4 (12.9%)
Died
3 (9.7%)
Euthanized
2 (6.5%)
Recovered/Normal
2 (6.5%)

Data Summary

Metric Value
Total adverse event reports 32
Reports involving death 5
Case-fatality rate (reported events) 1560.0%
Distinct species in reports 3
Distinct breeds in reports 19
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.

[No Api/Abi] Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 32 adverse event reports referencing [No Api/Abi], including 5 reports in which the animal died — a 1560.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: [No Api/Abi]. 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 [No Api/Abi] reports are Dog (19 reports), Cat (12 reports), Unknown (1 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (9), Retriever - Labrador (3), Poodle (unspecified) (2) 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 [No Api/Abi] are Lack of efficacy (endoparasite) - heartworm (8), Weight loss (7), Anaemia NOS (6), Anorexia (4). Of the 31 reports with a coded outcome, Ongoing is the leading category at 64.5%. 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 [No Api/Abi].

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