Drug profile

The FDA adverse-event record for Bismuth Subsalicylate

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

55
adverse-event reports
21.8%
death-coded share
Dog
most-reported species
25
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.
55
Total Reports
12
Deaths Reported
21.8%
Death Rate

Active Ingredients

Bismuth Subsalicylate

Administration Routes

UnknownOral

Species Affected

Dog 49
Cat 2
Horse 1
Other Mammals 1
Ferret 1
Unknown 1

Most Affected Breeds

Retriever - Labrador 5
Shepherd Dog - German 4
Terrier - Yorkshire 3
Pit Bull 3
Retriever - Golden 3
Terrier (unspecified) 3
Unknown 3
Chihuahua 3
Dachshund (unspecified) 2
Boxer (German Boxer) 2

Most Reported Reactions

Vomiting 25
Diarrhoea 21
Lethargy (see also Central nervous system depression in 'Neurological') 17
Anorexia 9
Bloody diarrhoea 6
Emesis 6
Death by euthanasia 6
Weight loss 6
Dehydration 6
Decreased appetite 6
Other abnormal test result NOS 5
Death 5

Outcome Breakdown

Recovered/Normal
18 (33.3%)
Ongoing
17 (31.5%)
Outcome Unknown
7 (13.0%)
Euthanized
6 (11.1%)
Died
6 (11.1%)

Bismuth Subsalicylate Adverse Event Insights

55 reports name Bismuth Subsalicylate; 12 recorded a death outcome (21.8% of reported events, not a population-level mortality rate). Active ingredient: Bismuth Subsalicylate. Administration routes: Unknown, Oral.

By species: Dog (49 reports), Cat (2 reports), Horse (1 reports). By breed: Retriever - Labrador (5), Shepherd Dog - German (4), Terrier - Yorkshire (3).

Leading clinical signs: Vomiting (25), Diarrhoea (21), Lethargy (see also Central nervous system depression in 'Neurological') (17), Anorexia (9). Outcome, 54 coded reports: Recovered/Normal leads at 33.3%.

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.