Drug profile

The FDA adverse-event record for Doxepin Hcl

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

13
adverse-event reports
15.4%
death-coded share
Dog
most-reported species
3
INEFFECTIVE, LOSS OF EFFECT - top reaction
Verify with FDA CVM →
Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
13
Total Reports
2
Deaths Reported
15.4%
Death Rate

Active Ingredients

Doxepin Hcl

Administration Routes

UnknownOral

Species Affected

Dog 13

Most Affected Breeds

Shepherd Dog - German 2
Terrier - Bull - American Pit 2
Mixed (Dog) 2
Bulldog - American 1
Crossbred Canine/dog 1
Greyhound 1
Terrier - Bull - Staffordshire 1
Dog (other) 1
Dog (unknown) 1
Beagle 1

Most Reported Reactions

INEFFECTIVE, LOSS OF EFFECT 3
Aggression 2
Weight loss 2
Elevated aspartate aminotransferase (AST) 2
Elevated alanine aminotransferase (ALT) 2
Lack of efficacy - NOS 2
Fever 2
Elevated serum alkaline phosphatase (SAP) 2
Bacterial skin infection NOS 1
Fungal skin infection NOS 1
Skin disorders NOS 1
SKIN SCRAPING ABNORMAL 1

Outcome Breakdown

Ongoing
7 (53.8%)
Recovered/Normal
3 (23.1%)
Euthanized
1 (7.7%)
Died
1 (7.7%)
Outcome Unknown
1 (7.7%)

Doxepin Hcl Adverse Event Insights

13 reports name Doxepin Hcl; 2 recorded a death outcome (15.4% of reported events, not a population-level mortality rate). Active ingredient: Doxepin Hcl. Administration routes: Unknown, Oral.

By species: Dog (13 reports). By breed: Shepherd Dog - German (2), Terrier - Bull - American Pit (2), Mixed (Dog) (2).

Leading clinical signs: INEFFECTIVE, LOSS OF EFFECT (3), Aggression (2), Weight loss (2), Elevated aspartate aminotransferase (AST) (2). Outcome, 13 coded reports: Ongoing leads at 53.8%.

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.