Prebiotics, Microorganisms

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117 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.
117
Total Reports
22
Deaths Reported
1880.0%
Death Rate

Active Ingredients

Prebiotics, Microorganisms

Administration Routes

UnknownOral

Species Affected

Dog 101
Cat 16

Most Affected Breeds

Domestic Shorthair 12
Retriever - Labrador 11
Terrier - Yorkshire 6
Shepherd Dog - German 5
Bulldog - French 5
Shih Tzu 4
Terrier - Boston 4
Beagle 4
Mixed (Dog) 4
Retriever - Golden 3

Most Reported Reactions

Diarrhoea 51
Vomiting 41
Lethargy (see also Central nervous system depression in 'Neurological') 35
Anorexia 21
Elevated alanine aminotransferase (ALT) 18
Bloody diarrhoea 18
Other abnormal test result NOS 17
Death by euthanasia 16
Elevated serum alkaline phosphatase (SAP) 15
Decreased appetite 13
Weight loss 12
Seizure NOS 11

Outcome Breakdown

Ongoing
71 (60.7%)
Euthanized
16 (13.7%)
Recovered/Normal
15 (12.8%)
Outcome Unknown
9 (7.7%)
Died
6 (5.1%)

Data Summary

Metric Value
Total adverse event reports 117
Reports involving death 22
Case-fatality rate (reported events) 1880.0%
Distinct species in reports 2
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.

Prebiotics, Microorganisms Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 117 adverse event reports referencing Prebiotics, Microorganisms, including 22 reports in which the animal died — a 1880.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Prebiotics, Microorganisms. Reported administration routes include 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 Prebiotics, Microorganisms reports are Dog (101 reports), Cat (16 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (12), Retriever - Labrador (11), Terrier - Yorkshire (6) 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 Prebiotics, Microorganisms are Diarrhoea (51), Vomiting (41), Lethargy (see also Central nervous system depression in 'Neurological') (35), Anorexia (21). Of the 117 reports with a coded outcome, Ongoing is the leading category at 60.7%. 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 Prebiotics, Microorganisms.

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