Drug profile

The FDA adverse-event record for Hydroxyzine Hcl

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

44
adverse-event reports
6.8%
death-coded share
Dog
most-reported species
18
Emesis - 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.
44
Total Reports
3
Deaths Reported
6.8%
Death Rate

Active Ingredients

Hydroxyzine Hcl

Administration Routes

OralUnknown

Species Affected

Dog 44

Most Affected Breeds

Shih Tzu 6
Pug 5
Retriever - Labrador 5
Spaniel - Cocker American 2
Terrier (unspecified) 2
Retriever (unspecified) 1
Bichon Frise 1
Terrier - Irish Soft-coated Wheaten 1
Schnauzer - Miniature 1
Pit Bull 1

Most Reported Reactions

Emesis 18
Lack of efficacy (ectoparasite) - flea 6
Lethargy (see also Central nervous system depression in 'Neurological') 5
Vomiting 5
Decreased appetite 4
Diarrhoea 4
Lack of efficacy - NOS 3
UNPALATABLE 2
Reluctant to move 2
Dullness 2
Behavioural disorder NOS 2
Pale mucous membrane 1

Outcome Breakdown

Recovered/Normal
22 (50.0%)
Outcome Unknown
10 (22.7%)
Ongoing
5 (11.4%)
Recovered with Sequela
4 (9.1%)
Died
2 (4.5%)
Euthanized
1 (2.3%)

Hydroxyzine Hcl Adverse Event Insights

44 reports name Hydroxyzine Hcl; 3 recorded a death outcome (6.8% of reported events, not a population-level mortality rate). Active ingredient: Hydroxyzine Hcl. Administration routes: Oral, Unknown.

By species: Dog (44 reports). By breed: Shih Tzu (6), Pug (5), Retriever - Labrador (5).

Leading clinical signs: Emesis (18), Lack of efficacy (ectoparasite) - flea (6), Lethargy (see also Central nervous system depression in 'Neurological') (5), Vomiting (5). Outcome, 44 coded reports: Recovered/Normal leads at 50.0%.

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.