Product label issues
VeDDRA Code: 99857
1,770 adverse event reports referencing this reaction
Species Most Affected
Breeds Most Affected
Associated Drugs
Data Summary
| Metric | Value |
|---|---|
| Total reports referencing reaction | 1,770 |
| Reports with fatal outcome | 14 |
| Case-fatality rate (reported events) | 80.0% |
| Species observed | 8 |
| Breeds observed | 20 |
| Drugs associated with reaction | 20 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 99857.
Product label issues Reaction Insights
The FDA Center for Veterinary Medicine database currently lists 1,770 adverse event reports that reference Product label issues as a reaction term, including 14 reports with a death outcome — a 80.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 99857, the standardized veterinary dictionary used to normalize clinical signs across submitters. Because reports are voluntary and often describe multiple concurrent signs per animal, the volume here reflects reporting intensity rather than true incidence in the broader pet population.
Product label issues appears most frequently in reports for Unknown (1,298 reports), Dog (367 reports), Cat (83 reports) — with Unknown dominating at 1,298 entries. Within those species, the breeds most often named alongside this reaction are Unknown (1,314), Chihuahua (73), Dog (unknown) (63). These distributions are influenced both by underlying breed popularity and by how veterinarians and owners code a given clinical sign, so they should be interpreted as a reporting fingerprint rather than a pure susceptibility ranking.
The drugs most commonly co-reported with Product label issues are Nitenpyram (714 reports), Praziquantel (278 reports), Febantel + Praziquantel + Pyrantel Pamoate (125 reports), Ivermectin, Pyrantel (67 reports), with Nitenpyram appearing alongside this reaction in 714 submissions. Co-reporting does not establish that any specific product caused the reaction — FDA CVM data captures temporal association only. The value of these aggregates is in flagging which therapeutic classes appear repeatedly alongside a given clinical sign, so owners and veterinarians can ask targeted questions about medications currently in use.
Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates
Read our methodology — how this data is sourced, computed, and verified.