Drug profile

The FDA adverse-event record for Simethicone

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

11
adverse-event reports
27.3%
death-coded share
Dog
most-reported species
3
Digestive tract disorder NOS - 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.
11
Total Reports
3
Deaths Reported
27.3%
Death Rate

Active Ingredients

Simethicone

Administration Routes

OralUnknown

Species Affected

Dog 9
Cat 1
Human 1

Most Affected Breeds

Retriever - Golden 2
Boxer (German Boxer) 2
Domestic Shorthair 1
Terrier - Yorkshire 1
Shepherd Dog - German 1
Unknown 1
Shepherd Dog - Belgian (unspecified) 1
Dog (unknown) 1
Pit Bull 1

Most Reported Reactions

Digestive tract disorder NOS 3
Dehydration 3
Death by euthanasia 3
Vomiting 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Decreased appetite 2
Flatulence 2
Elevated amylase 2
Anaemia NOS 2
Abnormal ultrasound finding 2
Lack of efficacy (endoparasite) - heartworm 2
Heart murmur 2

Outcome Breakdown

Outcome Unknown
5 (45.5%)
Euthanized
3 (27.3%)
Ongoing
3 (27.3%)

Simethicone Adverse Event Insights

11 reports name Simethicone; 3 recorded a death outcome (27.3% of reported events, not a population-level mortality rate). Active ingredient: Simethicone. Administration routes: Oral, Unknown.

By species: Dog (9 reports), Cat (1 reports), Human (1 reports). By breed: Retriever - Golden (2), Boxer (German Boxer) (2), Domestic Shorthair (1).

Leading clinical signs: Digestive tract disorder NOS (3), Dehydration (3), Death by euthanasia (3), Vomiting (3). Outcome, 11 coded reports: Outcome Unknown leads at 45.5%.

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.