Drug profile

The FDA adverse-event record for Sam-E, Silybin, Vitamin E, Zinc

495 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Sam-E, Silybin, Vitamin E, Zinc. See the species affected, top reactions, and outcomes below.

495
adverse-event reports
25.7%
death-coded share
Dog
most-reported species
242
Elevated alanine aminotransferase (ALT) - 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.
495
Total Reports
127
Deaths Reported
25.7%
Death Rate

Active Ingredients

Sam-E, Silybin, Vitamin E, Zinc

Administration Routes

UnknownOralSubcutaneousOphthalmic

Species Affected

Dog 474
Cat 21

Most Affected Breeds

Retriever - Labrador 126
Shih Tzu 20
Chihuahua 18
Maltese 15
Domestic Shorthair 14
Beagle 13
Retriever - Golden 11
Mixed (Dog) 10
Boxer (German Boxer) 10
Crossbred Canine/dog 10

Most Reported Reactions

Elevated alanine aminotransferase (ALT) 242
Vomiting 193
Elevated serum alkaline phosphatase (SAP) 187
Anorexia 150
Elevated total bilirubin 147
Lethargy (see also Central nervous system depression in 'Neurological') 143
Elevated liver enzymes 131
Other abnormal test result NOS 100
Abnormal ultrasound finding 89
Death by euthanasia 80
Weight loss 80
Icterus 68

Outcome Breakdown

Ongoing
279 (56.1%)
Euthanized
82 (16.5%)
Recovered/Normal
51 (10.3%)
Died
45 (9.1%)
Outcome Unknown
40 (8.0%)

Sam-E, Silybin, Vitamin E, Zinc Adverse Event Insights

495 reports name Sam-E, Silybin, Vitamin E, Zinc; 127 recorded a death outcome (25.7% of reported events, not a population-level mortality rate). Active ingredient: Sam-E, Silybin, Vitamin E, Zinc. Administration routes: Unknown, Oral, Subcutaneous, Ophthalmic.

By species: Dog (474 reports), Cat (21 reports). By breed: Retriever - Labrador (126), Shih Tzu (20), Chihuahua (18).

Leading clinical signs: Elevated alanine aminotransferase (ALT) (242), Vomiting (193), Elevated serum alkaline phosphatase (SAP) (187), Anorexia (150). Outcome, 497 coded reports: Ongoing leads at 56.1%.

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.