Reaction profile

The FDA adverse-event record for product label information incorrect

153 FDA adverse-event reports reference product label information incorrect (VeDDRA 99856). See the species, breeds, and drugs most associated with it below.

153
reports citing this reaction
0.0%
death-coded share
Unknown
most-affected species
Selamectin
most-associated drug
Verify with FDA CVM →
153
Total Reports
0
Deaths
0.0%
Death Rate

Species Most Affected

Unknown 138
Dog 8
Cat 7

Breeds Most Affected

Unknown 138
Domestic Shorthair 4
Dog (unknown) 2
Lhasa Apso 1
Deutsche Dogge, Great Dane 1
Cat (unknown) 1
Terrier - Yorkshire 1
Akita 1
Domestic Mediumhair 1
Retriever - Labrador 1

Associated Drugs

Selamectin 17
Nitenpyram 14
Afoxolaner 9
Firocoxib 7
Milbemycin Oxime 6
Spinosad 6
Fluralaner 13.64% 12-Week Chew 6
Melarsomine Dihydrochloride Injection 5
Fenbendazol Block 5
Imidacloprid + Moxidectin 4
Milbemycin Oxime + Spinosad 4
Ivermectin 68Mcg, Pyrantel Pamoate 57Mg, Praziquantel 57Mg 4
Fluralaner Chew Tablets 4
Melarsomine Dihydrochloride 4
Maropitant 3
Tiamulin Hydrogen Fumarate 2
Ivermectin 2
Levothyroxine Sodium 2
Device: Suture 2
Pyrantel Pamoate/Praziquantel 2

Product label information incorrect Reaction Insights

153 reports name Product label information incorrect; 0 recorded a death outcome (0.0% of reported events, not a population-level mortality rate). VeDDRA code: 99856.

By species: Unknown (138 reports), Dog (8 reports), Cat (7 reports). By breed: Unknown (138), Domestic Shorthair (4), Dog (unknown) (2).

Most co-reported drugs: Selamectin (17 reports), Nitenpyram (14 reports), Afoxolaner (9 reports), Firocoxib (7 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.