Distemper-Lepto Vaccine

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50 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.
50
Total Reports
3
Deaths Reported
600.0%
Death Rate

Active Ingredients

Distemper-Lepto Vaccine

Administration Routes

SubcutaneousUnknownOral

Species Affected

Dog 50

Most Affected Breeds

Terrier - Bull - American Pit 8
Crossbred Canine/dog 5
Boxer (German Boxer) 4
Retriever - Labrador 4
Bulldog - French 4
Siberian Husky 3
Chihuahua 2
Great Pyrenees 1
Poodle - Miniature 1
Beagle 1

Most Reported Reactions

Vomiting 24
Lethargy (see also Central nervous system depression in 'Neurological') 19
Facial swelling (see also 'Skin') 14
Anaphylaxis 13
Hives (see also 'Skin') 8
Seizure NOS 6
Diarrhoea 6
Pale mucous membrane 4
Periorbital oedema 3
Itching 3
Collapse NOS (see also 'Cardio-vascular' and 'Neurological disorders') 3
Death 3

Outcome Breakdown

Ongoing
34 (68.0%)
Recovered/Normal
11 (22.0%)
Died
3 (6.0%)
Outcome Unknown
2 (4.0%)

Data Summary

Metric Value
Total adverse event reports 50
Reports involving death 3
Case-fatality rate (reported events) 600.0%
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.

Distemper-Lepto Vaccine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 50 adverse event reports referencing Distemper-Lepto Vaccine, including 3 reports in which the animal died — a 600.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Distemper-Lepto Vaccine. Reported administration routes include Subcutaneous, Unknown, Oral. 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-Lepto Vaccine reports are Dog (50 reports), with Dog accounting for the largest share. Within those species, Terrier - Bull - American Pit (8), Crossbred Canine/dog (5), Boxer (German Boxer) (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 Distemper-Lepto Vaccine are Vomiting (24), Lethargy (see also Central nervous system depression in 'Neurological') (19), Facial swelling (see also 'Skin') (14), Anaphylaxis (13). Of the 50 reports with a coded outcome, Ongoing is the leading category at 68.0%. 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 Distemper-Lepto 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