Drug profile

The FDA adverse-event record for Simvastatin

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

16
adverse-event reports
0.0%
death-coded share
Human
most-reported species
7
Accidental exposure - 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.
16
Total Reports
0
Deaths Reported
0.0%
Death Rate

Active Ingredients

Simvastatin

Administration Routes

OralUnknown

Species Affected

Human 16

Most Affected Breeds

Unknown 16

Most Reported Reactions

Accidental exposure 7
Bad taste 5
Diarrhoea 3
Eye pain 2
High blood pressure 2
Nausea 2
Stomach upset 2
Tiredness 1
Emesis (multiple) 1
General illness 1
Increased heart rate 1
Other abnormal test result NOS 1

Outcome Breakdown

Recovered/Normal
9 (56.3%)
Outcome Unknown
4 (25.0%)
Ongoing
3 (18.8%)

Simvastatin Adverse Event Insights

16 reports name Simvastatin; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). Active ingredient: Simvastatin. Administration routes: Oral, Unknown.

By species: Human (16 reports). By breed: Unknown (16).

Leading clinical signs: Accidental exposure (7), Bad taste (5), Diarrhoea (3), Eye pain (2). Outcome, 16 coded reports: Recovered/Normal leads at 56.3%.

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.