Reaction profile

The FDA adverse-event record for patient instructions for use on label confusing

589 FDA adverse-event reports reference patient instructions for use on label confusing (VeDDRA 93081). See the species, breeds, and drugs most associated with it below.

589
reports citing this reaction
0.3%
death-coded share
Unknown
most-affected species
Nitenpyram
most-associated drug
Verify with FDA CVM →
589
Total Reports
2
Deaths
0.3%
Death Rate

Species Most Affected

Unknown 499
Dog 63
Cat 14
Human 13

Breeds Most Affected

Unknown 512
Chihuahua 15
Dog (unknown) 10
Domestic Shorthair 9
Terrier - Yorkshire 5
Maltese 3
Cat (unknown) 3
Retriever - Labrador 3
Crossbred Canine/dog 2
Retriever - Golden 2

Associated Drugs

Nitenpyram 235
Praziquantel 169
Febantel + Praziquantel + Pyrantel Pamoate 77
Imidacloprid 35
Fluralaner Spot-On Solution 22
Capromorelin Tartrate 12
Lotilaner 7
Milbemycin Oxime + Praziquantel 5
Milbemycin Oxime + Spinosad 4
Cyclosporine 4
Flea And Tick Shampoo 3
Grapiprant 3
Tylosin Tartrate 3
Miconazole + Polymyxin B + Prednisolone 2
Spinosad 2
Robenacoxib 2
Shampoo 2
Capromorelin 2
Deracoxib 1
Flea And Tick Product (Unknown) 1

Patient instructions for use on label confusing Reaction Insights

589 reports name Patient instructions for use on label confusing; 2 recorded a death outcome (0.3% of reported events, not a population-level mortality rate). VeDDRA code: 93081.

By species: Unknown (499 reports), Dog (63 reports), Cat (14 reports). By breed: Unknown (512), Chihuahua (15), Dog (unknown) (10).

Most co-reported drugs: Nitenpyram (235 reports), Praziquantel (169 reports), Febantel + Praziquantel + Pyrantel Pamoate (77 reports), Imidacloprid (35 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.