Drug profile

The FDA adverse-event record for Afoxolaner 11.3 Mg Chewable Tablets

1,048 FDA reports name Afoxolaner 11.3 Mg Chewable Tablets, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#173 of 2,679
by report volume (all drugs)
1,048
adverse-event reports
2.0%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Afoxolaner 11.3 Mg Chewable Tablets ranks #173 of 2679 by total reports (1,048) and #986 of 1130 by death-coded share (2.0%). 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)
#173
This drug, reports of 2679
#986
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. Afoxolaner 11.3 Mg Chewable Tablets has 1,048 reports now versus 1,048 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 Afoxolaner 11.3 Mg Chewable Tablets changes

Signature read: 1,048 reports place Afoxolaner 11.3 Mg Chewable Tablets in the upper third of FDA AER volume (#173 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.
1,048
Total Reports
21
Deaths Reported
2.0%
Death-coded share of reports

Active Ingredients

Afoxolaner 11.3 Mg Chewable Tablets

Administration Routes

OralUnknownOther

Species Affected

Dog 870
Unknown 174
Human 2
Cat 2

Most Affected Breeds

Terrier - Yorkshire 219
Unknown 182
Dog (unknown) 167
Shih Tzu 99
Poodle - Toy 37
Crossbred Canine/dog 36
Maltese 35
Chihuahua 30
Poodle - Miniature 29
Pinscher - Miniature 28

Most Reported Reactions

Lack of efficacy (tick) 244
Skin disorders NOS 202
Vomiting 185
Lack of efficacy (flea) 152
Diarrhoea 72
Lethargy (see also Central nervous system depression in 'Neurological') 67
Lack of efficacy (ectoparasite) - NOS 57
Underfilling, Container 42
Emesis 40
Scratching 38
Tablets, Abnormal 36
Pruritus 34

Outcome Breakdown

Outcome Unknown
615 (70.3%)
Recovered/Normal
209 (23.9%)
Ongoing
27 (3.1%)
Died
19 (2.2%)
Recovered with Sequela
3 (0.3%)
Euthanized
2 (0.2%)

Afoxolaner 11.3 Mg Chewable 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 Afoxolaner 11.3 Mg Chewable Tablets, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

Similar death-coded share

Nearest other drugs by death-coded share (2.0% here), distinct from the volume row.

What to do with this drug

  • Compare Afoxolaner 11.3 Mg Chewable 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 Afoxolaner 11.3 Mg Chewable Tablets (#173 of 2,679 by report volume); death-coded 2.0%. PlainBreed drug row · report volume stamp 1,048 · 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 →