B-12

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13 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.
13
Total Reports
6
Deaths Reported
4620.0%
Death Rate

Active Ingredients

B-12

Administration Routes

UnknownParenteralOral

Species Affected

Dog 9
Cat 4

Most Affected Breeds

Domestic Shorthair 2
Chihuahua 1
Terrier - Yorkshire 1
Retriever - Labrador 1
Retriever - Golden 1
Terrier - Lakeland 1
Collie - Smooth-haired 1
Dog (other) 1
Spitz - German Pomeranian 1
Ragdoll 1

Most Reported Reactions

Death by euthanasia 5
Diarrhoea 3
Lymphopenia 3
Vomiting 3
Lack of efficacy - NOS 2
Hypophosphataemia 2
Pain NOS 2
Product Defect, General 2
Lethargy (see also Central nervous system depression in Neurological) 2
Emesis 1
Bloody diarrhoea 1
Decreased drinking 1

Outcome Breakdown

Recovered/Normal
5 (38.5%)
Euthanized
5 (38.5%)
Ongoing
2 (15.4%)
Died
1 (7.7%)

Data Summary

Metric Value
Total adverse event reports 13
Reports involving death 6
Case-fatality rate (reported events) 4620.0%
Distinct species in reports 2
Distinct breeds in reports 12
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.

B-12 Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 13 adverse event reports referencing B-12, including 6 reports in which the animal died — a 4620.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: B-12. Reported administration routes include Unknown, Parenteral, 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 B-12 reports are Dog (9 reports), Cat (4 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (2), Chihuahua (1), Terrier - Yorkshire (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 B-12 are Death by euthanasia (5), Diarrhoea (3), Lymphopenia (3), Vomiting (3). Of the 13 reports with a coded outcome, Recovered/Normal 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 B-12.

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