Drug profile

The FDA adverse-event record for Fluralaner Spot-On Solution

14,506 FDA reports name Fluralaner Spot-On Solution, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#18 of 2,679
by report volume (all drugs)
14,506
adverse-event reports
2.6%
death-coded share
Cat
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Fluralaner Spot-On Solution ranks #18 of 2679 by total reports (14,506) and #942 of 1130 by death-coded share (2.6%). 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)
#18
This drug, reports of 2679
#942
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 Spot-On Solution has 14,506 reports now versus 14,225 in that prior snapshot: 281 more (2.0%).

Report change
+281
Death-coded reports
+5
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 Spot-On Solution changes

Signature read: 14,506 reports place Fluralaner Spot-On Solution in the upper third of FDA AER volume (#18 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.
14,506
Total Reports
384
Deaths Reported
2.6%
Death-coded share of reports

Active Ingredients

Fluralaner Spot-On Solution

Administration Routes

TopicalUnknownOralOtherSubcutaneousTransdermalRespiratory (Inhalation)OphthalmicIntraocularDental

Species Affected

Cat 10,165
Unknown 2,228
Dog 1,090
Human 1,011
Rabbit 5
Bobcat 2
Marsupial 1
Skunk 1
Deer 1
Mouse 1

Most Affected Breeds

Domestic Shorthair 6,196
Unknown 3,293
Domestic Longhair 968
Cat (unknown) 950
Domestic Mediumhair 701
Crossbred Canine/dog 299
Siamese 220
Maine Coon 202
Crossbred Feline/cat 188
Persian 101

Most Reported Reactions

Lack of efficacy (ectoparasite) - flea 3,469
Application site hair loss 1,872
Lethargy (see also Central nervous system depression in 'Neurological') 1,058
Drug administered at inappropriate site 960
Containers, Leaking 837
Underfilling, Container 733
Emesis (multiple) 683
Tubes, Leaking 558
Application site skin change NOS 521
Closure, Abnormal 514
Foaming at the mouth 490
Difficulty of Use 477

Outcome Breakdown

Ongoing
8,536 (69.5%)
Recovered/Normal
2,424 (19.7%)
Outcome Unknown
891 (7.3%)
Died
209 (1.7%)
Euthanized
176 (1.4%)
Recovered with Sequela
52 (0.4%)

Fluralaner Spot-On Solution: 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 Spot-On Solution, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other drugs by FDA report count (14,506 here).

Similar death-coded share

Nearest other drugs by death-coded share (2.6% here), distinct from the volume row.

What to do with this drug

  • Compare Fluralaner Spot-On Solution's report volume and death-coded share against similar drugs nationwide. See similar drugs
  • 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 Spot-On Solution (#18 of 2,679 by report volume); death-coded 2.6%. PlainBreed drug row · report volume stamp 14,506 · 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 →