Drug profile

The FDA adverse-event record for Amitriptyline

185 FDA reports name Amitriptyline, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#556 of 2,679
by report volume (all drugs)
185
adverse-event reports
5.4%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Amitriptyline ranks #556 of 2679 by total reports (185) and #766 of 1130 by death-coded share (5.4%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#556
This drug, reports of 2679
#766
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Amitriptyline has 185 reports now versus 183 in that prior snapshot: 2 more (1.1%).

Report change
+2
Death-coded reports
+0
Death-coded share
−0.1 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Amitriptyline changes

Signature read: 185 reports place Amitriptyline in the upper third of FDA AER volume (#556 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
185
Total Reports
10
Deaths Reported
5.4%
Death-coded share of reports

Active Ingredients

Amitriptyline

Administration Routes

OralUnknownTopicalTransdermalOther

Species Affected

Dog 125
Cat 55
Human 4
Unknown 1

Most Affected Breeds

Domestic Shorthair 41
Retriever - Labrador 12
Shih Tzu 8
Crossbred Canine/dog 6
Spaniel - King Charles Cavalier 6
Unknown 5
Domestic Mediumhair 5
Retriever - Golden 5
Shepherd Dog - Australian 5
Poodle (unspecified) 4

Most Reported Reactions

Vomiting 47
Lethargy (see also Central nervous system depression in 'Neurological') 27
Emesis 19
Diarrhoea 14
Pruritus 13
Lack of efficacy - NOS 12
Behavioural disorder NOS 12
Seizure NOS 11
Anorexia 10
Other abnormal test result NOS 10
Elevated alanine aminotransferase (ALT) 10
Elevated serum alkaline phosphatase (SAP) 9

Outcome Breakdown

Recovered/Normal
80 (43.7%)
Ongoing
52 (28.4%)
Outcome Unknown
33 (18.0%)
Recovered with Sequela
8 (4.4%)
Died
5 (2.7%)
Euthanized
5 (2.7%)

Amitriptyline: low death-coded share in the FDA AER row

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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Amitriptyline, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other drugs by FDA report count (185 here).

Similar death-coded share

Nearest other drugs by death-coded share (5.4% here), distinct from the volume row.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Amitriptyline (#556 of 2,679 by report volume); death-coded 5.4%. PlainBreed drug row · report volume stamp 185 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →