Human adverse-event record

Human Adverse Event Insights

The FDA Center for Veterinary Medicine database holds 8,623 adverse event reports for Human, distributed across 0 distinct breeds currently tracked in the system. Of those reports, 26 involved a death outcome, producing a 0.3% case-fatality rate among reported events, which reflects reporting severity bias rather than true population mortality. These figures are aggregated directly from openFDA's Animal & Veterinary Adverse Events endpoint and update as new voluntary submissions flow through pet owners, veterinarians, and drug manufacturers.

The most frequently reported clinical signs for Human are Accidental exposure (3,755 reports), Unclassifiable adverse event (1,683 reports), Injection site pain (614 reports), Eye irritation (602 reports), with Accidental exposure leading the reaction traffic at 3,755 submissions. On the product side, Fluralaner Spot-On Solution is the single most-referenced drug with 1,011 reports, followed by Selamectin (712), Imidacloprid + Moxidectin (382), Tulathromycin (264). This combination surfaces which therapeutic classes generate the most adverse event chatter for this species, a useful starting point when comparing Human reporting patterns against other companion animals in the dataset.

Of the 7,408 Human reports with a coded outcome, Outcome Unknown accounts for the largest share at 43.2%. Annual submission volume spans 98 to 617 reports across the 17 years on file, a range that reflects evolving owner awareness, veterinary reporting habits, and new product approvals rather than stable underlying incidence. The breed-level table below breaks these patterns down further, showing how the 0 tracked human breeds compare on volume, deaths, and average age at report. As with all FDA adverse event data, correlation is the ceiling, causation requires clinical investigation beyond what these aggregates can provide.