Distemper-Leptospirosis Vaccine

Verify with FDA CVM →

17 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.
17
Total Reports
2
Deaths Reported
1180.0%
Death Rate

Active Ingredients

Distemper-Leptospirosis Vaccine

Administration Routes

UnknownSubcutaneousParenteral

Species Affected

Dog 17

Most Affected Breeds

Boxer (German Boxer) 4
Corgi (unspecified) 2
Cattle Dog - Flanders (Bouvier) 1
Retriever - Labrador 1
Setter - Irish Red 1
Spitz - German Pomeranian 1
Brittany 1
Pit Bull 1
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 1
Retriever - Golden 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in Neurological) 5
Lack of efficacy (bacteria) - Borrelia 4
Vomiting 3
Limping 3
Weight loss 3
Lack of efficacy (endoparasite) - heartworm 3
Not eating 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Behavioural disorder NOS 2
Diarrhoea 2
Decreased appetite 2
Inappropriate urination 2

Outcome Breakdown

Outcome Unknown
9 (52.9%)
Recovered/Normal
3 (17.6%)
Ongoing
3 (17.6%)
Died
2 (11.8%)

Data Summary

Metric Value
Total adverse event reports 17
Reports involving death 2
Case-fatality rate (reported events) 1180.0%
Distinct species in reports 1
Distinct breeds in reports 13
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.

Distemper-Leptospirosis Vaccine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 17 adverse event reports referencing Distemper-Leptospirosis Vaccine, including 2 reports in which the animal died — a 1180.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Distemper-Leptospirosis Vaccine. Reported administration routes include Unknown, Subcutaneous, 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 Distemper-Leptospirosis Vaccine reports are Dog (17 reports), with Dog accounting for the largest share. Within those species, Boxer (German Boxer) (4), Corgi (unspecified) (2), Cattle Dog - Flanders (Bouvier) (1) 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 Distemper-Leptospirosis Vaccine are Lethargy (see also Central nervous system depression in Neurological) (5), Lack of efficacy (bacteria) - Borrelia (4), Vomiting (3), Limping (3). Of the 17 reports with a coded outcome, Outcome Unknown is the leading category at 52.9%. 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 Distemper-Leptospirosis Vaccine.

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