Reaction profile

The FDA adverse-event record for labels, abnormal

207 FDA adverse-event reports reference labels, abnormal (VeDDRA 99014). See the species, breeds, and drugs most associated with it below.

207
reports citing this reaction
1.0%
death-coded share
Unknown
most-affected species
Fluralaner Spot-On Solution
most-associated drug
Verify with FDA CVM →
207
Total Reports
2
Deaths
1.0%
Death Rate

Species Most Affected

Unknown 190
Dog 6
Human 6
Cat 5

Breeds Most Affected

Unknown 196
Domestic Shorthair 5
Dog (unknown) 2
Portuguese Water Dog 1
Terrier - Airedale 1
Chihuahua 1
Terrier - West Highland White 1

Associated Drugs

Fluralaner Spot-On Solution 23
Nitenpyram 16
Afoxolaner 16
Firocoxib 9
Ivermectin 8
Fluralaner Chew Tablets 8
Praziquantel 7
Phenylpropanolamine Hcl 6
Fenbendazol Granules 6
Milbemycin/Lufenuron Tablets 6
Recombinant Human Insulin 5
Spinosad 5
Dexamethasone Sodium Phosphate 5
Hydrocortisone Aceponate/Miconazole Nitrate/Gentamicin Sulfate 4
Ivermectin + Pyrantel As Pamoate Salt 4
Carprofen 4
Dexamethasone 4
Milbemycin Oxime + Praziquantel 4
Ivermectin 0.5% Pour-On Topical Solution 3
Pimobendan 3

Labels, Abnormal Reaction Insights

207 reports name Labels, Abnormal; 2 recorded a death outcome (1.0% of reported events, not a population-level mortality rate). VeDDRA code: 99014.

By species: Unknown (190 reports), Dog (6 reports), Human (6 reports). By breed: Unknown (196), Domestic Shorthair (5), Dog (unknown) (2).

Most co-reported drugs: Fluralaner Spot-On Solution (23 reports), Nitenpyram (16 reports), Afoxolaner (16 reports), Firocoxib (9 reports).

Read these counts as reporting volume, not risk: per our methodology, co-reporting reflects temporal association captured in voluntary submissions, not proof that a drug caused this reaction. A widely-prescribed drug will rack up more raw co-reports at an identical true rate than a rarely-used one, so compare within similar-exposure products.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.