{"topic_id":"ade_afoxolaner_adverse_events","category":"ade","context":"---\ntopic_id: ade_afoxolaner_adverse_events\ncategory: ade\ntitle: \"FDA ADE reports for afoxolaner (isoxazoline ectoparasiticide (flea/tick)) — total reports, species & reaction breakdown\"\nlang: en\nsource: \"openFDA animalandveterinary/event.json (FDA CVM adverse event reports), pulled 2026-07-21\"\nsource_file: pdf-raw/ade/ade_active_ingredients_2026-07-21.json\ndate_parsed: 2026-07-21\ntokens_estimated: 215\nverification:\n  method: derived_from_dataset\n  claims: 34\n  note: \"Values are report-level aggregates computed from the cited openFDA JSON source; not verbatim substrings. Counts are not additive (one report may list multiple reactions/animals).\"\n  date: 2026-07-21\nsource_document: \"FDA FAERS / openFDA Animal & Veterinary Event Reports\"\ncitation:\n  authority: \"US FDA Center for Veterinary Medicine (openFDA animal & veterinary event database)\"\n  title: \"FDA ADE reports for afoxolaner (isoxazoline ectoparasiticide (flea/tick)) — total reports, species & reaction breakdown\"\n  url: \"\"\n  retrieved: \"2026-07-21\"\n  ref: \"\"\n  doc_type: \"open dataset (JSON API)\"\n  needs_review: true\nauthority_tier: T1\nauthority_tier_basis: \"T1:fda\"\nauthority_tier_date: 2026-08-04\n---\n\n# afoxolaner — FDA Animal & Veterinary Adverse Event (ADE) Reports\n\nSource: openFDA `animalandveterinary/event.json`, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-07-21. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. afoxolaner is a isoxazoline ectoparasiticide (flea/tick).\n\n## Total reports\nafoxolaner: 69037\n\n## Reports by species (top entries)\n- Dog 63981\n- Human 92\n- Cat 82\n- Other 3\n- Other Canids 3\n-  2\n\n## Top reported reactions (VEDDRA terms, top entries)\n- Vomiting 15987\n- Diarrhoea 6128\n- Lethargy (see also Central nervous system depression in 'Neurological') 5710\n- Lack of efficacy (ectoparasite) - tick NOS 4991\n- Lack of efficacy (ectoparasite) - flea 4532\n- Seizure NOS 4406\n- Lack of efficacy (bacteria) - Borrelia 3554\n- Lack of efficacy (tick) 3389\n- Skin disorders NOS 2626\n- Lack of efficacy (bacteria) - NOS 2606\n\n\"Lack of efficacy\" terms denote product-performance reports, not adverse reactions.\n\nSource JSON: `pdf-raw/ade/ade_active_ingredients_2026-07-21.json` (openFDA animalandveterinary/event.json, pulled 2026-07-21).\n","sources":["US FDA Center for Veterinary Medicine (openFDA animal & veterinary event database) — FDA ADE reports for afoxolaner (isoxazoline ectoparasiticide (flea/tick)) — total reports, species & reaction breakdown (retrieved 2026-07-21)"],"source":{"authority":"US FDA Center for Veterinary Medicine (openFDA animal & veterinary event database)","title":"FDA ADE reports for afoxolaner (isoxazoline ectoparasiticide (flea/tick)) — total reports, species & reaction breakdown","url":"https://open.fda.gov/data/animal-and-veterinary/","retrieved":"2026-07-21","ref":"","doc_type":"open dataset (JSON API)","source_document":"FDA FAERS / openFDA Animal & Veterinary Event Reports","verification_file":"pdf-raw/ade/ade_active_ingredients_2026-07-21.json"},"source_document":"FDA FAERS / openFDA Animal & Veterinary Event Reports","source_file":"pdf-raw/ade/ade_active_ingredients_2026-07-21.json","trust":{"authority_tier":"T1","fidelity":"verbatim","license":null,"display_grade":"A"},"tokens_estimated":215,"generated_at":null,"tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}