Drug profile

The FDA adverse-event record for Unspecified Fluoxetine

10 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Unspecified Fluoxetine. See the species affected, top reactions, and outcomes below.

10
adverse-event reports
30.0%
death-coded share
Dog
most-reported species
3
Elevated creatine-kinase (CK) - 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.
10
Total Reports
3
Deaths Reported
30.0%
Death Rate

Active Ingredients

Unspecified Fluoxetine

Administration Routes

OralUnknown

Species Affected

Dog 7
Cat 3

Most Affected Breeds

Terrier - Bull - American Pit 2
Domestic Shorthair 2
Retriever - Golden 1
Bulldog - American 1
Bulldog - French 1
Terrier - Jack Russell 1
Retriever - Labrador 1
Cat (unknown) 1

Most Reported Reactions

Elevated creatine-kinase (CK) 3
Inflammatory bowel disorder 3
Abnormal radiograph finding 3
Dullness 3
Neurological signs NOS 3
Head pressing 3
Ataxia 3
Death by euthanasia 3
Lethargy (see also Central nervous system depression in Neurological) 3
Urinary incontinence 2
Faecal incontinence 2
Abnormal posture NOS 2

Outcome Breakdown

Ongoing
3 (30.0%)
Euthanized
3 (30.0%)
Outcome Unknown
2 (20.0%)
Recovered/Normal
2 (20.0%)

Unspecified Fluoxetine Adverse Event Insights

10 reports name Unspecified Fluoxetine; 3 recorded a death outcome (30.0% of reported events, not a population-level mortality rate). Active ingredient: Unspecified Fluoxetine. Administration routes: Oral, Unknown.

By species: Dog (7 reports), Cat (3 reports). By breed: Terrier - Bull - American Pit (2), Domestic Shorthair (2), Retriever - Golden (1).

Leading clinical signs: Elevated creatine-kinase (CK) (3), Inflammatory bowel disorder (3), Abnormal radiograph finding (3), Dullness (3). Outcome, 10 coded reports: Ongoing leads at 30.0%.

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.