Drug profile

The FDA adverse-event record for Fluralaner 13.64% Chew Tablets

873 FDA reports name Fluralaner 13.64% Chew Tablets, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#197 of 2,679
by report volume (all drugs)
873
adverse-event reports
0.8%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Fluralaner 13.64% Chew Tablets ranks #197 of 2679 by total reports (873) and #1084 of 1130 by death-coded share (0.8%). 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)
#197
This drug, reports of 2679
#1084
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 13.64% Chew Tablets has 873 reports now versus 873 in that prior snapshot: 0 the same number of (0.0%).

Report change
+0
Death-coded reports
+0
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 13.64% Chew Tablets changes

Signature read: 873 reports place Fluralaner 13.64% Chew Tablets in the upper third of FDA AER volume (#197 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.
873
Total Reports
7
Deaths Reported
0.8%
Death-coded share of reports

Active Ingredients

Fluralaner 13.64% Chew Tablets

Administration Routes

OralUnknown

Species Affected

Dog 861
Unknown 10
Cat 2

Most Affected Breeds

Crossbred Canine/dog 227
Retriever - Labrador 74
Chihuahua 31
Retriever - Golden 29
Shepherd Dog - German 28
Pit Bull 28
Shih Tzu 27
Shepherd Dog - Australian 23
Terrier - Yorkshire 23
Terrier (unspecified) 20

Most Reported Reactions

Vomiting 311
Lack of efficacy (ectoparasite) - flea 141
Lack of efficacy (ectoparasite) - tick NOS 138
Emesis (multiple) 83
Lethargy (see also Central nervous system depression in 'Neurological') 76
Diarrhoea 51
Drug administration error 45
Product Defect, General 37
Product problem 33
UNPALATABLE 33
Lack of efficacy (bacteria) - NOS 27
Seizure NOS 27

Outcome Breakdown

Ongoing
432 (50.0%)
Recovered/Normal
408 (47.2%)
Outcome Unknown
15 (1.7%)
Euthanized
4 (0.5%)
Died
3 (0.3%)
Recovered with Sequela
2 (0.2%)

Fluralaner 13.64% Chew Tablets: 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 13.64% Chew Tablets, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Fluralaner 13.64% Chew Tablets'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 13.64% Chew Tablets (#197 of 2,679 by report volume); death-coded 0.8%. PlainBreed drug row · report volume stamp 873 · 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 →