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).