Oral Bordetella Canine - 1081.01 - Phn3259

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81 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.
81
Total Reports
3
Deaths Reported
370.0%
Death Rate

Active Ingredients

Oral Bordetella Canine - 1081.01 - Phn3259

Administration Routes

OralUnknownSubcutaneousNasal

Species Affected

Dog 81

Most Affected Breeds

Retriever - Labrador 11
Terrier - Yorkshire 6
Chihuahua 5
Retriever - Golden 4
Boxer (German Boxer) 4
Spaniel - King Charles Cavalier 3
Poodle - Toy 3
Crossbred Canine/dog 3
Shepherd Dog - German 3
Shih Tzu 2

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 20
Vomiting 17
Lack of efficacy (bacteria) - NOS 10
Cough 9
Injection site pain 7
Diarrhoea 7
Anorexia 7
Emesis 4
Injection site lump 4
Pruritus 3
Pale mucous membrane 3
Anaphylaxis 3

Outcome Breakdown

Outcome Unknown
36 (44.4%)
Recovered/Normal
32 (39.5%)
Ongoing
10 (12.3%)
Died
2 (2.5%)
Euthanized
1 (1.2%)

Data Summary

Metric Value
Total adverse event reports 81
Reports involving death 3
Case-fatality rate (reported events) 370.0%
Distinct species in reports 1
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.

Oral Bordetella Canine - 1081.01 - Phn3259 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 81 adverse event reports referencing Oral Bordetella Canine - 1081.01 - Phn3259, including 3 reports in which the animal died — a 370.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Oral Bordetella Canine - 1081.01 - Phn3259. Reported administration routes include Oral, Unknown, Subcutaneous, Nasal. 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 Oral Bordetella Canine - 1081.01 - Phn3259 reports are Dog (81 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (11), Terrier - Yorkshire (6), Chihuahua (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 Oral Bordetella Canine - 1081.01 - Phn3259 are Lethargy (see also Central nervous system depression in 'Neurological') (20), Vomiting (17), Lack of efficacy (bacteria) - NOS (10), Cough (9). Of the 81 reports with a coded outcome, Outcome Unknown is the leading category at 44.4%. 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 Oral Bordetella Canine - 1081.01 - Phn3259.

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