Probiotic

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589 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.
589
Total Reports
86
Deaths Reported
1460.0%
Death Rate

Active Ingredients

Probiotic

Administration Routes

OralUnknownTopicalIntramuscularOther

Species Affected

Dog 487
Cat 93
Horse 6
Cattle 2
Human 1

Most Affected Breeds

Domestic Shorthair 60
Retriever - Labrador 56
Retriever - Golden 27
Crossbred Canine/dog 25
Shepherd Dog - German 23
Terrier - Yorkshire 19
Chihuahua 16
Shih Tzu 13
Boxer (German Boxer) 11
Domestic Longhair 11

Most Reported Reactions

Diarrhoea 168
Vomiting 137
Lethargy (see also Central nervous system depression in 'Neurological') 83
Anorexia 64
Weight loss 57
Lethargy (see also Central nervous system depression in Neurological) 57
Other abnormal test result NOS 56
Death by euthanasia 55
Not eating 47
Decreased appetite 46
Lack of efficacy - NOS 46
Elevated alanine aminotransferase (ALT) 43

Outcome Breakdown

Ongoing
238 (40.4%)
Outcome Unknown
133 (22.6%)
Recovered/Normal
130 (22.1%)
Euthanized
54 (9.2%)
Died
32 (5.4%)
Recovered with Sequela
2 (0.3%)

Data Summary

Metric Value
Total adverse event reports 589
Reports involving death 86
Case-fatality rate (reported events) 1460.0%
Distinct species in reports 5
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.

Probiotic Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 589 adverse event reports referencing Probiotic, including 86 reports in which the animal died — a 1460.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Probiotic. Reported administration routes include Oral, Unknown, Topical, Intramuscular. 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 Probiotic reports are Dog (487 reports), Cat (93 reports), Horse (6 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (60), Retriever - Labrador (56), Retriever - Golden (27) 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 Probiotic are Diarrhoea (168), Vomiting (137), Lethargy (see also Central nervous system depression in 'Neurological') (83), Anorexia (64). Of the 589 reports with a coded outcome, Ongoing is the leading category at 40.4%. 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 Probiotic.

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