Drug profile

The FDA adverse-event record for Paroxetine Hcl

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

20
adverse-event reports
10.0%
death-coded share
Dog
most-reported species
7
Lethargy (see also Central nervous system depression in 'Neurological') - 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.
20
Total Reports
2
Deaths Reported
10.0%
Death Rate

Active Ingredients

Paroxetine Hcl

Administration Routes

OralUnknown

Species Affected

Dog 14
Cat 4
Human 2

Most Affected Breeds

Retriever - Golden 3
Domestic Shorthair 3
Unknown 2
Doberman Pinscher 2
Crossbred Canine/dog 2
Maltese 1
Bengal 1
Shepherd (unspecified) 1
Dachshund - Standard Long-haired 1
Setter - English 1

Most Reported Reactions

Lethargy (see also Central nervous system depression in 'Neurological') 7
Vomiting 4
Ataxia 3
Lack of efficacy - NOS 3
Hyperactivity 2
Accidental exposure 2
Other abnormal test result NOS 2
Leucocytosis NOS 2
Elevated blood urea nitrogen (BUN) 2
Hypoproteinaemia 2
Pale mucous membrane 2
Vasculitis 2

Outcome Breakdown

Recovered/Normal
10 (50.0%)
Ongoing
5 (25.0%)
Outcome Unknown
3 (15.0%)
Euthanized
2 (10.0%)

Paroxetine Hcl Adverse Event Insights

20 reports name Paroxetine Hcl; 2 recorded a death outcome (10.0% of reported events, not a population-level mortality rate). Active ingredient: Paroxetine Hcl. Administration routes: Oral, Unknown.

By species: Dog (14 reports), Cat (4 reports), Human (2 reports). By breed: Retriever - Golden (3), Domestic Shorthair (3), Unknown (2).

Leading clinical signs: Lethargy (see also Central nervous system depression in 'Neurological') (7), Vomiting (4), Ataxia (3), Lack of efficacy - NOS (3). Outcome, 20 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.