sarolaner — FDA Animal & Veterinary ADE Reports by Species (Dog vs Cat)
Source: openFDA animalandveterinary/event.json, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-08-16. This topic covers adverse-event reports for the active ingredient Sarolaner (queried as drug.active_ingredients.name). Overall report total for this ingredient: 79692. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. "Serious" follows the FDA serious_ae flag. Species values are as filed in each report. The Dog and Cat figures below are subsets of this ingredient's overall report total and do not necessarily sum to it (other species and reports with no species listed are excluded).
Dog (67742 reports)
- Serious adverse events (FDA
serious_aeflag): 34093 (50.3% of 67742) - Top reported reactions (VEDDRA terms):
- Vomiting 12831
- Seizure NOS 6910
- Lack of efficacy (bacteria) - Borrelia 6734
- Lack of efficacy (endoparasite) - heartworm 6095
- Diarrhoea 5215
Cat (8207 reports)
- Serious adverse events (FDA
serious_aeflag): 2800 (34.1% of 8207) - Top reported reactions (VEDDRA terms):
- Application site hair loss 2294
- Application site alopecia 707
- Application site scab 686
- Lack of efficacy (ectoparasite) - flea 685
- Vomiting 682
Honest scope note
This topic is a species cross-section of FDA adverse-event reports for a single active ingredient, queried by drug.active_ingredients.name. Figures are aggregates of spontaneously reported adverse events and reflect reporting volume, not incidence or risk per animal treated. "Lack of efficacy" and similar terms denote product-performance reports, not adverse reactions. Different marketed presentations of the same compound (e.g. chewable vs spot-on) may be filed under distinct name strings in openFDA and are not merged here. Source JSON: pdf-raw/ade/ade_species_slice_expand_2026-08-16.json (openFDA animalandveterinary/event.json, pulled 2026-08-16).