Forti-Flora

Verify with FDA CVM →

24 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.
24
Total Reports
4
Deaths Reported
1670.0%
Death Rate

Active Ingredients

Forti-Flora

Administration Routes

OralUnknown

Species Affected

Dog 17
Cat 7

Most Affected Breeds

Domestic Shorthair 3
Poodle - Toy 3
Retriever - Labrador 3
Terrier - Yorkshire 2
Poodle (unspecified) 2
Cat (other) 2
Chihuahua 1
Boxer (German Boxer) 1
Beagle 1
Bulldog - American 1

Most Reported Reactions

Diarrhoea 5
Emesis (multiple) 4
Abnormal radiograph finding 4
Vomiting 4
Weight loss 3
Pain NOS 3
Limb weakness 3
Elevated blood urea nitrogen (BUN) 2
Lameness 2
Loose stool 2
Death 2
Hind limb ataxia 2

Outcome Breakdown

Ongoing
16 (66.7%)
Died
2 (8.3%)
Recovered/Normal
2 (8.3%)
Outcome Unknown
2 (8.3%)
Euthanized
2 (8.3%)

Data Summary

Metric Value
Total adverse event reports 24
Reports involving death 4
Case-fatality rate (reported events) 1670.0%
Distinct species in reports 2
Distinct breeds in reports 15
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.

Forti-Flora Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 24 adverse event reports referencing Forti-Flora, including 4 reports in which the animal died — a 1670.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Forti-Flora. Reported administration routes include Oral, Unknown. 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 Forti-Flora reports are Dog (17 reports), Cat (7 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (3), Poodle - Toy (3), Retriever - Labrador (3) 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 Forti-Flora are Diarrhoea (5), Emesis (multiple) (4), Abnormal radiograph finding (4), Vomiting (4). Of the 24 reports with a coded outcome, Ongoing is the leading category at 66.7%. 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 Forti-Flora.

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