Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain

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41 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.
41
Total Reports
5
Deaths Reported
1220.0%
Death Rate

Active Ingredients

Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain

Administration Routes

SubcutaneousUnknownParenteral

Species Affected

Dog 39
Unknown 2

Most Affected Breeds

Retriever - Golden 6
Maltese 4
Retriever - Labrador 4
Boxer (German Boxer) 3
Shepherd Dog - German 3
Pit Bull 2
Pinscher - Miniature 2
Shepherd Dog - Australian 2
Shih Tzu 2
Crossbred Canine/dog 2

Most Reported Reactions

Lethargy (see also Central nervous system depression in Neurological) 7
Lack of efficacy (bacteria) - Leptospira 7
Injection site lump 6
Cough 5
Fever 5
Elevated serum alkaline phosphatase (ALP) 5
Injection site swelling 5
Elevated alanine aminotransferase (ALT) 4
Vomiting 4
Low blood urea nitrogen (BUN) 4
Not eating 4
Hives (see also Skin) 3

Outcome Breakdown

Outcome Unknown
15 (38.5%)
Recovered/Normal
13 (33.3%)
Ongoing
6 (15.4%)
Euthanized
3 (7.7%)
Died
2 (5.1%)

Data Summary

Metric Value
Total adverse event reports 41
Reports involving death 5
Case-fatality rate (reported events) 1220.0%
Distinct species in reports 2
Distinct breeds in reports 19
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.

Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 41 adverse event reports referencing Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain, including 5 reports in which the animal died — a 1220.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain. Reported administration routes include Subcutaneous, Unknown, Parenteral. 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 Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain reports are Dog (39 reports), Unknown (2 reports), with Dog accounting for the largest share. Within those species, Retriever - Golden (6), Maltese (4), Retriever - Labrador (4) 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 Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain are Lethargy (see also Central nervous system depression in Neurological) (7), Lack of efficacy (bacteria) - Leptospira (7), Injection site lump (6), Cough (5). Of the 39 reports with a coded outcome, Outcome Unknown is the leading category at 38.5%. 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 Leptospira Canicola, Hond Urecht Strain,Leptospira Grippotyphosa, F4397 Strain,Leptospira Icterohaemorrhagiae, Copenhageni Strain,Leptospira Pomona, Kennewicki Strain.

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