Drug profile

The FDA adverse-event record for Amitriptyline

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

176
adverse-event reports
5.7%
death-coded share
Dog
most-reported species
44
Vomiting - 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.
176
Total Reports
10
Deaths Reported
5.7%
Death Rate

Active Ingredients

Amitriptyline

Administration Routes

OralUnknownTopicalTransdermalOther

Species Affected

Dog 120
Cat 51
Human 4
Unknown 1

Most Affected Breeds

Domestic Shorthair 40
Retriever - Labrador 11
Shih Tzu 8
Crossbred Canine/dog 6
Spaniel - King Charles Cavalier 6
Unknown 5
Retriever - Golden 5
Shepherd Dog - Australian 5
Domestic Mediumhair 4
Poodle (unspecified) 4

Most Reported Reactions

Vomiting 44
Lethargy (see also Central nervous system depression in 'Neurological') 27
Emesis 19
Diarrhoea 13
Lack of efficacy - NOS 11
Behavioural disorder NOS 11
Seizure NOS 11
Anorexia 10
Other abnormal test result NOS 10
Elevated alanine aminotransferase (ALT) 10
Pruritus 10
Elevated serum alkaline phosphatase (SAP) 9

Outcome Breakdown

Recovered/Normal
77 (44.3%)
Ongoing
47 (27.0%)
Outcome Unknown
32 (18.4%)
Recovered with Sequela
8 (4.6%)
Died
5 (2.9%)
Euthanized
5 (2.9%)

Amitriptyline Adverse Event Insights

176 reports name Amitriptyline; 10 recorded a death outcome (5.7% of reported events, not a population-level mortality rate). Active ingredient: Amitriptyline. Administration routes: Oral, Unknown, Topical, Transdermal.

By species: Dog (120 reports), Cat (51 reports), Human (4 reports). By breed: Domestic Shorthair (40), Retriever - Labrador (11), Shih Tzu (8).

Leading clinical signs: Vomiting (44), Lethargy (see also Central nervous system depression in 'Neurological') (27), Emesis (19), Diarrhoea (13). Outcome, 174 coded reports: Recovered/Normal leads at 44.3%.

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.