Fluralaner Powder For Inj Susp

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83 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.
83
Total Reports
4
Deaths Reported
480.0%
Death Rate

Active Ingredients

Fluralaner Powder For Inj Susp

Administration Routes

SubcutaneousUnknownOtherTopical

Species Affected

Dog 80
Human 3

Most Affected Breeds

Crossbred Canine/dog 29
Unknown 6
Bulldog - French 5
Dachshund - Miniature 3
Chihuahua 3
Spitz - German Pomeranian 3
Retriever - Labrador 3
Pug 2
Spaniel - King Charles 2
Retriever - Chesapeake Bay 2

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 19
Emesis (multiple) 17
Lethargy (see also Central nervous system depression in Neurological) 15
Hypersensitivity reaction 12
Facial swelling (see also Skin) 9
Diarrhoea 8
Fever 8
Hives (see also Skin) 7
Panting 7
Not himself/herself 5
Decreased appetite 4
Death 4

Outcome Breakdown

Ongoing
50 (60.2%)
Recovered/Normal
21 (25.3%)
Outcome Unknown
8 (9.6%)
Died
4 (4.8%)

Data Summary

Metric Value
Total adverse event reports 83
Reports involving death 4
Case-fatality rate (reported events) 480.0%
Distinct species in reports 2
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.

Fluralaner Powder For Inj Susp Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 83 adverse event reports referencing Fluralaner Powder For Inj Susp, including 4 reports in which the animal died — a 480.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Fluralaner Powder For Inj Susp. Reported administration routes include Subcutaneous, Unknown, Other, Topical. 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 Fluralaner Powder For Inj Susp reports are Dog (80 reports), Human (3 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (29), Unknown (6), Bulldog - French (5) 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 Fluralaner Powder For Inj Susp are Lack of efficacy (ectoparasite) - flea (19), Emesis (multiple) (17), Lethargy (see also Central nervous system depression in Neurological) (15), Hypersensitivity reaction (12). Of the 83 reports with a coded outcome, Ongoing is the leading category at 60.2%. 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 Fluralaner Powder For Inj Susp.

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