B12

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27 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.
27
Total Reports
4
Deaths Reported
1480.0%
Death Rate

Active Ingredients

B12

Administration Routes

UnknownSubcutaneousOralParenteral

Species Affected

Cat 14
Dog 12
Human 1

Most Affected Breeds

Domestic Shorthair 8
Domestic Mediumhair 3
Crossbred Canine/dog 2
Mountain Cur 2
Terrier - Yorkshire 2
Mountain Dog - Bernese 2
Schnauzer - Miniature 1
Unknown 1
Spitz - German Pomeranian 1
Retriever - Golden 1

Most Reported Reactions

Vomiting 8
Diarrhoea 5
Weight loss 5
Decreased appetite 5
Ataxia 5
Elevated alanine aminotransferase (ALT) 5
Lethargy (see also Central nervous system depression in Neurological) 5
Application site reddening 3
Twitching 3
Seizure NOS 3
Anaemia NOS 3
Bloody diarrhoea 3

Outcome Breakdown

Ongoing
11 (40.7%)
Outcome Unknown
8 (29.6%)
Recovered/Normal
4 (14.8%)
Died
2 (7.4%)
Euthanized
2 (7.4%)

Data Summary

Metric Value
Total adverse event reports 27
Reports involving death 4
Case-fatality rate (reported events) 1480.0%
Distinct species in reports 3
Distinct breeds in reports 14
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.

B12 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 27 adverse event reports referencing B12, including 4 reports in which the animal died — a 1480.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: B12. Reported administration routes include Unknown, Subcutaneous, Oral, 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 B12 reports are Cat (14 reports), Dog (12 reports), Human (1 reports), with Cat accounting for the largest share. Within those species, Domestic Shorthair (8), Domestic Mediumhair (3), Crossbred Canine/dog (2) 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 B12 are Vomiting (8), Diarrhoea (5), Weight loss (5), Decreased appetite (5). Of the 27 reports with a coded outcome, Ongoing is the leading category at 40.7%. 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 B12.

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