Drug profile

The FDA adverse-event record for Fluralaner

3,723 FDA reports name Fluralaner, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#62 of 2,679
by report volume (all drugs)
3,723
adverse-event reports
5.9%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Fluralaner ranks #62 of 2679 by total reports (3,723) and #744 of 1130 by death-coded share (5.9%). 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)
#62
This drug, reports of 2679
#744
This drug, death share of 1130

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. Fluralaner has 3,723 reports now versus 3,597 in that prior snapshot: 126 more (3.5%).

Report change
+126
Death-coded reports
+6
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 Fluralaner changes

Signature read: 3,723 reports place Fluralaner in the upper third of FDA AER volume (#62 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.
3,723
Total Reports
218
Deaths Reported
5.9%
Death-coded share of reports

Active Ingredients

Fluralaner

Administration Routes

OralUnknownTopicalSubcutaneousOtherParenteralDentalIntragastricTransdermal

Species Affected

Dog 3,552
Cat 167
Unknown 3
Other Canids 1

Most Affected Breeds

Retriever - Labrador 506
Retriever - Golden 204
Crossbred Canine/dog 177
Shepherd Dog - German 149
Chihuahua 124
Shepherd Dog - Australian 118
Shih Tzu 112
Domestic Shorthair 110
Dog (unknown) 106
Pit Bull 101

Most Reported Reactions

Vomiting 926
Lack of efficacy (endoparasite) - heartworm 464
Lethargy (see also Central nervous system depression in 'Neurological') 361
Diarrhoea 321
Other abnormal test result NOS 222
Seizure NOS 189
Not eating 145
Weight loss 142
Anorexia 129
Lethargy (see also Central nervous system depression in Neurological) 125
Behavioural disorder NOS 122
Death by euthanasia 111

Outcome Breakdown

Outcome Unknown
1,531 (41.2%)
Ongoing
968 (26.1%)
Recovered/Normal
966 (26.0%)
Died
113 (3.0%)
Euthanized
105 (2.8%)
Recovered with Sequela
29 (0.8%)

Fluralaner: low 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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Fluralaner, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

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 Fluralaner (#62 of 2,679 by report volume); death-coded 5.9%. PlainBreed drug row · report volume stamp 3,723 · 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 →