S-Adenosyl-Methionine (Same) + Silybin

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19 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.
19
Total Reports
3
Deaths Reported
1580.0%
Death Rate

Active Ingredients

S-Adenosyl-Methionine (Same) + Silybin

Administration Routes

OralTopical

Species Affected

Dog 19

Most Affected Breeds

Terrier - Boston 2
Poodle - Miniature 2
Shih Tzu 2
Dachshund - Miniature 1
Brittany 1
Dog (other) 1
Schnauzer - Miniature 1
Crossbred Canine/dog 1
Retriever - Golden 1
Chihuahua 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 10
Elevated serum alkaline phosphatase (SAP) 5
Decreased appetite 5
Anorexia 5
Diarrhoea 4
Hyperglycaemia 4
Elevated alanine aminotransferase (ALT) 3
Elevated blood urea nitrogen (BUN) 3
Hyponatremia 3
Elevated liver enzymes 3
Death by euthanasia 3
Underdose 3

Outcome Breakdown

Outcome Unknown
13 (68.4%)
Recovered/Normal
3 (15.8%)
Euthanized
3 (15.8%)

Data Summary

Metric Value
Total adverse event reports 19
Reports involving death 3
Case-fatality rate (reported events) 1580.0%
Distinct species in reports 1
Distinct breeds in reports 16
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

S-Adenosyl-Methionine (Same) + Silybin Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 19 adverse event reports referencing S-Adenosyl-Methionine (Same) + Silybin, including 3 reports in which the animal died — a 1580.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: S-Adenosyl-Methionine (Same) + Silybin. Reported administration routes include Oral, Topical. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in S-Adenosyl-Methionine (Same) + Silybin reports are Dog (19 reports), with Dog accounting for the largest share. Within those species, Terrier - Boston (2), Poodle - Miniature (2), Shih Tzu (2) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with S-Adenosyl-Methionine (Same) + Silybin are Lethargy (see also Central nervous system depression in 'Neurological') (10), Elevated serum alkaline phosphatase (SAP) (5), Decreased appetite (5), Anorexia (5). Of the 19 reports with a coded outcome, Outcome Unknown is the leading category at 68.4%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on S-Adenosyl-Methionine (Same) + Silybin.

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

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial