Drug profile

The FDA adverse-event record for Afoxolaner 68 Mg Chewable Tablets

1,668 FDA reports name Afoxolaner 68 Mg Chewable Tablets, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#128 of 2,679
by report volume (all drugs)
1,668
adverse-event reports
2.3%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Afoxolaner 68 Mg Chewable Tablets ranks #128 of 2679 by total reports (1,668) and #964 of 1130 by death-coded share (2.3%). 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)
#128
This drug, reports of 2679
#964
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 68 Mg Chewable Tablets has 1,668 reports now versus 1,668 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 68 Mg Chewable Tablets changes

Signature read: 1,668 reports place Afoxolaner 68 Mg Chewable Tablets in the upper third of FDA AER volume (#128 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.
1,668
Total Reports
39
Deaths Reported
2.3%
Death-coded share of reports

Active Ingredients

Afoxolaner 68 Mg Chewable Tablets

Administration Routes

OralUnknownOther

Species Affected

Dog 1,553
Unknown 113
Human 2

Most Affected Breeds

Crossbred Canine/dog 322
Unknown 127
Dog (unknown) 126
Collie - Border 86
Mixed (Dog) 79
Retriever - Labrador 78
Spaniel - Cocker American 52
Retriever - Golden 43
Shepherd Dog - German 41
Terrier - Bull - Staffordshire 38

Most Reported Reactions

Vomiting 341
Skin disorders NOS 313
Lack of efficacy (tick) 288
Lack of efficacy (flea) 215
Diarrhoea 174
Lethargy (see also Central nervous system depression in 'Neurological') 143
Pruritus 100
Emesis 68
Scratching 66
Anorexia 51
Lack of efficacy (ectoparasite) - NOS 48
Inappetence 46

Outcome Breakdown

Outcome Unknown
891 (57.2%)
Recovered/Normal
537 (34.4%)
Ongoing
88 (5.6%)
Died
22 (1.4%)
Euthanized
18 (1.2%)
Recovered with Sequela
3 (0.2%)

Afoxolaner 68 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 68 Mg Chewable Tablets, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

  • Compare Afoxolaner 68 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 68 Mg Chewable Tablets (#128 of 2,679 by report volume); death-coded 2.3%. PlainBreed drug row · report volume stamp 1,668 · 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 →