Reaction profile
The FDA adverse-event record for product defect, general
8,467 FDA adverse-event reports reference product defect, general (VeDDRA 99021). See the species, breeds, and drugs most associated with it below.
- 8,467
- reports citing this reaction
- 0.7%
- death-coded share
- Unknown
- most-affected species
- Fluralaner Chew Tablets
- most-associated drug
Species Most Affected
Breeds Most Affected
Associated Drugs
Product Defect, General Reaction Insights
8,467 reports name Product Defect, General; 63 recorded a death outcome (0.7% of reported events, not a population-level mortality rate). VeDDRA code: 99021.
By species: Unknown (7,384 reports), Dog (882 reports), Cat (92 reports). By breed: Unknown (7,437), Dog (unknown) (181), Crossbred Canine/dog (103).
Most co-reported drugs: Fluralaner Chew Tablets (1,210 reports), Fluralaner 13.64% 12-Week Chew (1,049 reports), Polysulfated Glycosaminoglycan (653 reports), Pyrantel Pamoate;Sarolaner (308 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.