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FDA ADE reports for Primidone

ade_primidone_adverse_events

ade en 2026-07-22

Primidone — FDA Animal & Veterinary Adverse Event (ADE) Reports

Source: openFDA animalandveterinary/event.json, the FDA Center for Veterinary Medicine (CVM) adverse event report database. Data pulled 2026-07-22. Counts are report-level: one report may list multiple reactions and multiple animals, so figures are not additive and do not imply causation. Primidone is a active ingredient.

Total reports

Primidone: 153

Reports by species (top entries)

  • Dog 147
  • Human 2
  • Cat 1

Top reported reactions (VEDDRA terms, top entries)

  • Polydipsia 29
  • Ataxia 23
  • Depression 21
  • Elevated serum alkaline phosphatase (SAP) 21
  • Elevated alanine aminotransferase (ALT) 17
  • Apprehension 16
  • Hyperactivity 14
  • Confusion 13
  • Elevated bile acids 13
  • Pacing 13

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b19.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).

Sources

FDA ADE reports for Primidone (active ingredient) — total reports, species & reaction breakdown
Source document: FDA FAERS / openFDA Animal & Veterinary Event Reports
US FDA Center for Veterinary Medicine (openFDA animal & veterinary event database)retrieved 2026-07-22

Verification file: pdf-raw/ade/ade_active_ingredients_2026-07-22_b19.json

Link points to the issuing authority's site; a direct document link is still being verified.