Drug profile

The FDA adverse-event record for Promethazine

14 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Promethazine. See the species affected, top reactions, and outcomes below.

14
adverse-event reports
7.1%
death-coded share
Dog
most-reported species
9
Vomiting - top reaction
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Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
14
Total Reports
1
Deaths Reported
7.1%
Death Rate

Active Ingredients

Promethazine

Administration Routes

UnknownOral

Species Affected

Dog 11
Human 3

Most Affected Breeds

Unknown 3
Retriever - Labrador 3
Pit Bull 2
Deutsche Dogge, Great Dane 1
Dachshund - Miniature 1
Maltese 1
Terrier - Jack Russell 1
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 1
Terrier - Bull - American Pit 1

Most Reported Reactions

Vomiting 9
Diarrhoea 6
Not eating 3
Weight loss 3
Elevated alanine aminotransferase (ALT) 3
Lethargy (see also Central nervous system depression in 'Neurological') 2
Lethargy (see also Central nervous system depression in Neurological) 2
Not himself/herself 2
Acute renal failure 2
Elevated creatinine 2
Elevated blood urea nitrogen (BUN) 2
Hyperphosphataemia 2

Outcome Breakdown

Recovered/Normal
8 (57.1%)
Outcome Unknown
4 (28.6%)
Euthanized
1 (7.1%)
Ongoing
1 (7.1%)

Promethazine Adverse Event Insights

14 reports name Promethazine; 1 recorded a death outcome (7.1% of reported events, not a population-level mortality rate). Active ingredient: Promethazine. Administration routes: Unknown, Oral.

By species: Dog (11 reports), Human (3 reports). By breed: Unknown (3), Retriever - Labrador (3), Pit Bull (2).

Leading clinical signs: Vomiting (9), Diarrhoea (6), Not eating (3), Weight loss (3). Outcome, 14 coded reports: Recovered/Normal leads at 57.1%.

Read these counts as reporting volume, not risk: per our methodology, a widely-prescribed drug will rack up more raw FDA reports in a given year than a rarely-used one at an identical true rate, so we recommend comparing within similar-exposure products rather than across the full 2025 catalog.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

Every figure on PlainBreed is rendered directly from FDA openFDA adverse event data, no number is typed in by an editor. This page draws directly on FDA openFDA data, no figure is typed in by an editor. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.