Reaction profile

The FDA adverse-event record for drug label confusion

230 FDA adverse-event reports reference drug label confusion (VeDDRA 99826). See the species, breeds, and drugs most associated with it below.

230
reports citing this reaction
1.3%
death-coded share
Unknown
most-affected species
Nitenpyram
most-associated drug
Verify with FDA CVM →
230
Total Reports
3
Deaths
1.3%
Death Rate

Species Most Affected

Unknown 164
Dog 54
Cat 10
Human 1
Cattle 1

Breeds Most Affected

Unknown 165
Chihuahua 9
Crossbred Canine/dog 7
Dog (unknown) 7
Domestic Shorthair 6
Pit Bull 4
Spitz - German Pomeranian 3
Terrier - Jack Russell 2
American Pit Bull Terrier 2
Retriever - Labrador 2

Associated Drugs

Nitenpyram 149
Milbemycin Oxime + Praziquantel 9
Milbemycin Oxime + Spinosad 8
Spinosad 8
Ivermectin 7
Imidacloprid 7
Robenacoxib 4
Heartworm Prevention (Unknown) 4
Betamethasone + Florfenicol + Terbinafine 4
Flea Collar 3
Grapiprant 3
Levothyroxine Sodium 3
Lotilaner 3
Praziquantel 3
Flea Product (Unknown) 2
Flea Shampoo 2
Milbemycin Oxime 2
Ivermectin + Pyrantel As Pamoate Salt 2
Febantel + Praziquantel + Pyrantel Pamoate 2
Cloprostenol Sodium 1

Drug label confusion Reaction Insights

230 reports name Drug label confusion; 3 recorded a death outcome (1.3% of reported events, not a population-level mortality rate). VeDDRA code: 99826.

By species: Unknown (164 reports), Dog (54 reports), Cat (10 reports). By breed: Unknown (165), Chihuahua (9), Crossbred Canine/dog (7).

Most co-reported drugs: Nitenpyram (149 reports), Milbemycin Oxime + Praziquantel (9 reports), Milbemycin Oxime + Spinosad (8 reports), Spinosad (8 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.