Sam-E, Silybin, Vitamin E, Zinc

495 adverse event reports submitted to the FDA

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

2570.0%

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%)

Source: FDA Center for Veterinary Medicine — Adverse Event Reports. Data reflects voluntary submissions and may not represent actual incidence rates.