Reaction profile
The FDA adverse-event record for product label issues
1,770 FDA adverse-event reports reference product label issues (VeDDRA 99857). See the species, breeds, and drugs most associated with it below.
- 1,770
- reports citing this reaction
- 0.8%
- death-coded share
- Unknown
- most-affected species
- Nitenpyram
- most-associated drug
Species Most Affected
Breeds Most Affected
Associated Drugs
Product label issues Reaction Insights
1,770 reports name Product label issues; 14 recorded a death outcome (0.8% of reported events, not a population-level mortality rate). VeDDRA code: 99857.
By species: Unknown (1,298 reports), Dog (367 reports), Cat (83 reports). By breed: Unknown (1,314), Chihuahua (73), Dog (unknown) (63).
Most co-reported drugs: Nitenpyram (714 reports), Praziquantel (278 reports), Febantel + Praziquantel + Pyrantel Pamoate (125 reports), Ivermectin, Pyrantel (67 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.