Canine Lepto*4(Orig S-P Us) Kb

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194 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.
194
Total Reports
32
Deaths Reported
1650.0%
Death Rate

Active Ingredients

Canine Lepto*4(Orig S-P Us) Kb

Administration Routes

SubcutaneousUnknown

Species Affected

Dog 194

Most Affected Breeds

Crossbred Canine/dog 56
Retriever - Labrador 17
Bulldog - French 7
Siberian Husky 6
Shepherd Dog - Australian 6
Chihuahua 5
Shih Tzu 5
Shepherd Dog - German 5
Maltese 5
Retriever - Golden 5

Most Reported Reactions

Vomiting 50
Emesis (multiple) 40
Lethargy (see also Central nervous system depression in 'Neurological') 37
Anorexia 23
Diarrhoea 22
Death by euthanasia 21
Other abnormal test result NOS 19
Neutrophilia 17
Fever 16
Lethargy (see also Central nervous system depression in Neurological) 16
Elevated alanine aminotransferase (ALT) 13
Not eating 13

Outcome Breakdown

Ongoing
75 (38.7%)
Recovered/Normal
67 (34.5%)
Euthanized
21 (10.8%)
Outcome Unknown
13 (6.7%)
Died
11 (5.7%)
Recovered with Sequela
7 (3.6%)

Data Summary

Metric Value
Total adverse event reports 194
Reports involving death 32
Case-fatality rate (reported events) 1650.0%
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.

Canine Lepto*4(Orig S-P Us) Kb Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 194 adverse event reports referencing Canine Lepto*4(Orig S-P Us) Kb, including 32 reports in which the animal died — a 1650.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Canine Lepto*4(Orig S-P Us) Kb. Reported administration routes include Subcutaneous, 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 Canine Lepto*4(Orig S-P Us) Kb reports are Dog (194 reports), with Dog accounting for the largest share. Within those species, Crossbred Canine/dog (56), Retriever - Labrador (17), Bulldog - French (7) 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 Canine Lepto*4(Orig S-P Us) Kb are Vomiting (50), Emesis (multiple) (40), Lethargy (see also Central nervous system depression in 'Neurological') (37), Anorexia (23). Of the 194 reports with a coded outcome, Ongoing is the leading category at 38.7%. 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 Canine Lepto*4(Orig S-P Us) Kb.

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