Drug profile

The FDA adverse-event record for Fortiflora

71 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Fortiflora. See the species affected, top reactions, and outcomes below.

71
adverse-event reports
18.3%
death-coded share
Dog
most-reported species
17
Vomiting - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
71
Total Reports
13
Deaths Reported
18.3%
Death Rate

Active Ingredients

Fortiflora

Administration Routes

UnknownOral

Species Affected

Dog 53
Cat 18

Most Affected Breeds

Domestic Shorthair 10
Retriever - Labrador 7
Terrier - Bull - American Pit 3
Terrier (unspecified) 3
Terrier - Yorkshire 3
Spitz - German Pomeranian 3
Maltese 2
Domestic Longhair 2
Schnauzer - Miniature 2
Siberian Husky 2

Most Reported Reactions

Vomiting 17
Diarrhoea 17
Lethargy (see also Central nervous system depression in Neurological) 14
Death by euthanasia 10
Elevated blood urea nitrogen (BUN) 9
Anorexia 8
Decreased appetite 8
Urinary tract infection 7
Emesis (multiple) 6
Bloody diarrhoea 6
Ataxia 5
Other abnormal test result NOS 5

Outcome Breakdown

Ongoing
38 (53.5%)
Recovered/Normal
12 (16.9%)
Euthanized
10 (14.1%)
Outcome Unknown
8 (11.3%)
Died
3 (4.2%)

Fortiflora Adverse Event Insights

71 reports name Fortiflora; 13 recorded a death outcome (18.3% of reported events, not a population-level mortality rate). Active ingredient: Fortiflora. Administration routes: Unknown, Oral.

By species: Dog (53 reports), Cat (18 reports). By breed: Domestic Shorthair (10), Retriever - Labrador (7), Terrier - Bull - American Pit (3).

Leading clinical signs: Vomiting (17), Diarrhoea (17), Lethargy (see also Central nervous system depression in Neurological) (14), Death by euthanasia (10). Outcome, 71 coded reports: Ongoing leads at 53.5%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.