Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21

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98 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.
98
Total Reports
11
Deaths Reported
1120.0%
Death Rate

Active Ingredients

Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21

Administration Routes

Subcutaneous

Species Affected

Dog 98

Most Affected Breeds

Retriever - Labrador 10
Shepherd Dog - German 7
Bulldog - French 5
Bulldog 5
Mixed (Dog) 4
Terrier - Jack Russell 4
Retriever - Golden 4
Retriever (unspecified) 3
Shepherd Dog - Australian 3
Collie - Border 3

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 33
Vomiting 25
Lack of efficacy (ectoparasite) - tick NOS 15
Other abnormal test result NOS 13
Anorexia 11
Diarrhoea 10
Fever 7
Injection site pain 7
Shaking 7
Hives (see also 'Skin') 7
Lameness 6
Musculoskeletal disorder NOS 6

Outcome Breakdown

Ongoing
50 (51.0%)
Recovered/Normal
32 (32.7%)
Died
6 (6.1%)
Outcome Unknown
5 (5.1%)
Euthanized
5 (5.1%)

Data Summary

Metric Value
Total adverse event reports 98
Reports involving death 11
Case-fatality rate (reported events) 1120.0%
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.

Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 98 adverse event reports referencing Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21, including 11 reports in which the animal died — a 1120.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21. 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 Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21 reports are Dog (98 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (10), Shepherd Dog - German (7), 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 Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21 are Lethargy (see also Central nervous system depression in 'Neurological') (33), Vomiting (25), Lack of efficacy (ectoparasite) - tick NOS (15), Other abnormal test result NOS (13). Of the 98 reports with a coded outcome, Ongoing is the leading category at 51.0%. 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 Recombinant E. Coli Ecl19; Recombinant E. Coli Bl21.

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