Drug profile

The FDA adverse-event record for Paroxetine Hcl

21 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Paroxetine Hcl. Species, reactions, and outcomes follow.

#1760 of 2,679
by report volume (all drugs)
21
adverse-event reports
9.5%
death-coded share
Dog
most-reported species
Verify with FDA CVM →

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Paroxetine Hcl ranks #1727 of 2679 by total reports (21). Death-coded-share rank requires at least 50 reports. 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)
#1727
This drug, reports of 2679

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. Paroxetine Hcl has 21 reports now versus 21 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
Death-coded share
+0.0 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 Paroxetine Hcl changes

Signature read: death-coded report count at 2 is the most distinctive stamp on Paroxetine Hcl's FDA AER row.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
21
Total Reports
2
Deaths Reported
9.5%
Death-coded share of reports

Active Ingredients

Paroxetine Hcl

Administration Routes

OralUnknown

Species Affected

Dog 14
Cat 5
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
Accidental exposure 3
Behavioural disorder NOS 3
Lack of efficacy - NOS 3
Hyperactivity 2
Other abnormal test result NOS 2
Elevated blood urea nitrogen (BUN) 2
Hypoproteinaemia 2
Anaemia NOS 2
Leucocytosis NOS 2

Outcome Breakdown

Recovered/Normal
10 (47.6%)
Ongoing
6 (28.6%)
Outcome Unknown
3 (14.3%)
Euthanized
2 (9.5%)

Paroxetine Hcl Adverse Event Insights

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.

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 Paroxetine Hcl (#1760 of 2,679 by report volume); death-coded 9.5%. PlainBreed drug row · death-coded report count stamp 2 · 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 →