Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips

Verify with FDA CVM →

25 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.
25
Total Reports
4
Deaths Reported
1600.0%
Death Rate

Active Ingredients

Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips

Administration Routes

Subcutaneous

Species Affected

Dog 25

Most Affected Breeds

Retriever - Labrador 6
Shepherd Dog - German 3
Retriever - Golden 2
Dog (unknown) 2
Great Pyrenees 1
Bulldog 1
Poodle (unspecified) 1
Beagle 1
Siberian Husky 1
Shepherd Dog - Belgian Malinois 1

Most Reported Reactions

Lack of efficacy (tick) 6
Anaphylaxis 4
Vomiting 4
Lack of efficacy (ectoparasite) - tick NOS 4
Lack of efficacy - NOS 3
Death by euthanasia 3
Lethargy (see also Central nervous system depression in 'Neurological') 3
Fever 3
Facial swelling (see also 'Skin') 3
Lack of efficacy (bacteria) - Borrelia 3
Panting 2
Anorexia 2

Outcome Breakdown

Ongoing
18 (72.0%)
Euthanized
2 (8.0%)
Died
2 (8.0%)
Recovered/Normal
2 (8.0%)
Outcome Unknown
1 (4.0%)

Data Summary

Metric Value
Total adverse event reports 25
Reports involving death 4
Case-fatality rate (reported events) 1600.0%
Distinct species in reports 1
Distinct breeds in reports 16
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.

Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 25 adverse event reports referencing Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips, including 4 reports in which the animal died — a 1600.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips. Reported administration route is Subcutaneous. 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 Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips reports are Dog (25 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (6), Shepherd Dog - German (3), Retriever - Golden (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 Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips are Lack of efficacy (tick) (6), Anaphylaxis (4), Vomiting (4), Lack of efficacy (ectoparasite) - tick NOS (4). Of the 25 reports with a coded outcome, Ongoing is the leading category at 72.0%. 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 Borrelia Burgdorferi Strain B-31 -6 Pass 032188;Borrelia Burgdorferi Strain Ips.

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