Restlessness
VeDDRA Code: 119
6,234 adverse event reports referencing this reaction
Species Most Affected
Breeds Most Affected
Associated Drugs
Data Summary
| Metric | Value |
|---|---|
| Total reports referencing reaction | 6,234 |
| Reports with fatal outcome | 484 |
| Case-fatality rate (reported events) | 780.0% |
| Species observed | 10 |
| Breeds observed | 20 |
| Drugs associated with reaction | 20 |
Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER); reaction term coded under VeDDRA 119.
Restlessness Reaction Insights
The FDA Center for Veterinary Medicine database currently lists 6,234 adverse event reports that reference Restlessness as a reaction term, including 484 reports with a death outcome — a 780.0% case-fatality figure calculated across only those events where this reaction was coded. The reaction is indexed in the openFDA system under VeDDRA code 119, 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.
Restlessness appears most frequently in reports for Dog (5,508 reports), Cat (646 reports), Horse (52 reports) — with Dog dominating at 5,508 entries. Within those species, the breeds most often named alongside this reaction are Retriever - Labrador (567), Crossbred Canine/dog (472), Domestic Shorthair (300). 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 Restlessness are Milbemycin Oxime + Spinosad (675 reports), Afoxolaner (493 reports), Carprofen (313 reports), Spinosad (297 reports), with Milbemycin Oxime + Spinosad appearing alongside this reaction in 675 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.