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FDA ADE reports for Promethazine

ade_promethazine_adverse_events

ade en 2026-07-22

Promethazine — 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. Promethazine is a active ingredient.

Total reports

Promethazine: 14

Reports by species (top entries)

  • Dog 11
  • Human 3

Top reported reactions (VEDDRA terms, top entries)

  • Vomiting 9
  • Diarrhoea 6
  • Elevated alanine aminotransferase (ALT) 3
  • Not eating 3
  • Weight loss 3
  • Acute renal failure 2
  • Decreased skin turgor 2
  • Dry mucous membrane 2
  • Elevated blood urea nitrogen (BUN) 2
  • Elevated creatinine 2

Source JSON: pdf-raw/ade/ade_active_ingredients_2026-07-22_b34.json (openFDA animalandveterinary/event.json, pulled 2026-07-22).

Sources

FDA ADE reports for Promethazine (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_b34.json

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

Machine access

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Raw JSON ↗ llm.txt OpenAPI