Drug profile

The FDA adverse-event record for Unspecified Fluoxetine

14 FDA reports name Unspecified Fluoxetine, a lower-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#2205 of 2,679
by report volume (all drugs)
14
adverse-event reports
35.7%
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, Unspecified Fluoxetine ranks #2133 of 2679 by total reports (14). 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)
#2133
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. Unspecified Fluoxetine has 14 reports now versus 11 in that prior snapshot: 3 more (27.3%).

Report change
+3
Death-coded reports
+1
Death-coded share
−0.6 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 Unspecified Fluoxetine changes

Signature read: Unspecified Fluoxetine's 35.7% death-coded share is among the highest in the openFDA drug corpus.

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
14
Total Reports
5
Deaths Reported
35.7%
Death-coded share of reports

Active Ingredients

Unspecified Fluoxetine

Administration Routes

OralUnknown

Species Affected

Dog 10
Cat 4

Most Affected Breeds

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

Most Reported Reactions

Abnormal radiograph finding 4
Death by euthanasia 4
Intentional misuse 3
Elevated creatine-kinase (CK) 3
Inflammatory bowel disorder 3
Dullness 3
Neurological signs NOS 3
Head pressing 3
Ataxia 3
Lethargy (see also Central nervous system depression in Neurological) 3
Lack of efficacy - NOS 3
Emesis (multiple) 2

Outcome Breakdown

Ongoing
5 (35.7%)
Euthanized
4 (28.6%)
Outcome Unknown
2 (14.3%)
Recovered/Normal
2 (14.3%)
Died
1 (7.1%)

Unspecified Fluoxetine: high death-coded share in the FDA AER row

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 Unspecified Fluoxetine (#2205 of 2,679 by report volume); death-coded 35.7%. PlainBreed drug row · death-coded share stamp 35.7% · 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 →