Drug profile

The FDA adverse-event record for S-Adenosylmethionine + Silybin

179 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference S-Adenosylmethionine + Silybin. See the species affected, top reactions, and outcomes below.

179
adverse-event reports
9.5%
death-coded share
Dog
most-reported species
37
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.
179
Total Reports
17
Deaths Reported
9.5%
Death Rate

Active Ingredients

S-Adenosylmethionine + Silybin

Administration Routes

UnknownOralIntravenousIntraocular

Species Affected

Dog 168
Cat 10
Human 1

Most Affected Breeds

Retriever - Labrador 24
Crossbred Canine/dog 11
Shih Tzu 10
Chihuahua 8
Beagle 8
Spitz - German Pomeranian 7
Domestic Shorthair 7
Maltese 6
Dog (unknown) 5
Chow Chow 5

Most Reported Reactions

Elevated alanine aminotransferase (ALT) 37
Vomiting 33
Diarrhoea 20
Elevated serum alkaline phosphatase (SAP) 17
Elevated blood urea nitrogen (BUN) 15
Elevated liver enzymes 15
Weight loss 15
Lack of efficacy - NOS 14
Other abnormal test result NOS 13
Death by euthanasia 13
Elevated serum alkaline phosphatase (ALP) 12
Loose stool 11

Outcome Breakdown

Outcome Unknown
65 (36.3%)
Ongoing
63 (35.2%)
Recovered/Normal
31 (17.3%)
Euthanized
13 (7.3%)
Died
4 (2.2%)
Recovered with Sequela
3 (1.7%)

S-Adenosylmethionine + Silybin Adverse Event Insights

179 reports name S-Adenosylmethionine + Silybin; 17 recorded a death outcome (9.5% of reported events, not a population-level mortality rate). Active ingredient: S-Adenosylmethionine + Silybin. Administration routes: Unknown, Oral, Intravenous, Intraocular.

By species: Dog (168 reports), Cat (10 reports), Human (1 reports). By breed: Retriever - Labrador (24), Crossbred Canine/dog (11), Shih Tzu (10).

Leading clinical signs: Elevated alanine aminotransferase (ALT) (37), Vomiting (33), Diarrhoea (20), Elevated serum alkaline phosphatase (SAP) (17). Outcome, 179 coded reports: Outcome Unknown leads at 36.3%.

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.