Drug profile

The FDA adverse-event record for Fluralaner Extended Release

Name: Fluralaner Extended Release - FDA Animal Adverse Event Reports
Creator: PlainBreed
License: https://creativecommons.org/publicdomain/zero/1.0/

16 FDA reports name Fluralaner Extended Release, a lower-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#2021 of 2,679
by report volume (all drugs): 16
adverse-event reports: 6.3%
death-coded share: Dog
most-reported species

Compiled by PlainBreed

Verify with FDA CVM →

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Fluralaner Extended Release ranks #1995 of 2679 by total reports (16). 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): #1995
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.

Signature read: 16 reports place Fluralaner Extended Release in the lower third of FDA AER volume (#2021 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.

Total Reports

Deaths Reported

6.3%

Death-coded share of reports

Active Ingredients

Fluralaner Extended Release

Administration Routes

SubcutaneousUnknown

Species Affected

Dog 16

Most Affected Breeds

Terrier (unspecified) 2

Retriever - Golden 2

Spaniel (unspecified) 2

Mountain Dog - Bernese 1

Corgi - Welsh Pembroke 1

Spaniel - Springer English 1

Rottweiler 1

Shih Tzu 1

Spaniel - King Charles Cavalier 1

Poodle (unspecified) 1

Most Reported Reactions

Vomiting 5

Emesis (multiple) 4

Hypersensitivity reaction 3

Facial swelling (see also Skin) 2

Itching 2

Head shake - ear disorder 2

Panting 2

Hypocalcaemia 2

Shaking 2

Reddening of the skin 2

Laboured breathing 2

Anaphylaxis 2

Outcome Breakdown

Recovered/Normal

9 (56.3%)

Ongoing

6 (37.5%)

Died

1 (6.3%)

Fluralaner Extended Release: lower report volume 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

Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
Browse the full drug directory to compare report counts across products. All drugs

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 Fluralaner Extended Release (#2021 of 2,679 by report volume); death-coded 6.3%. PlainBreed drug row · report volume stamp 16 · 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 →