Drug profile

The FDA adverse-event record for Diphenhydramine Hcl

2,109 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Diphenhydramine Hcl. See the species affected, top reactions, and outcomes below.

2,109
adverse-event reports
14.2%
death-coded share
Dog
most-reported species
827
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.
2,109
Total Reports
300
Deaths Reported
14.2%
Death Rate

Active Ingredients

Diphenhydramine Hcl

Administration Routes

UnknownOralIntramuscularIntravenousSubcutaneousOtherSubconjunctivalOphthalmicNasal

Species Affected

Dog 1,960
Cat 146
Horse 2
Ferret 1

Most Affected Breeds

Retriever - Labrador 181
Terrier - Bull - American Pit 158
Chihuahua 115
Domestic Shorthair 107
Boxer (German Boxer) 88
Terrier - Yorkshire 86
Maltese 64
Retriever - Golden 58
Shih Tzu 58
Bulldog - French 55

Most Reported Reactions

Vomiting 827
Lethargy (see also Central nervous system depression in 'Neurological') 594
Facial swelling (see also 'Skin') 323
Anaphylaxis 302
Diarrhoea 299
Hives (see also 'Skin') 270
Anorexia 198
Pale mucous membrane 185
Other abnormal test result NOS 178
Fever 161
Death 156
Death by euthanasia 139

Outcome Breakdown

Ongoing
1,179 (55.8%)
Recovered/Normal
508 (24.1%)
Died
162 (7.7%)
Euthanized
140 (6.6%)
Outcome Unknown
122 (5.8%)
Recovered with Sequela
1 (0.0%)

Diphenhydramine Hcl Adverse Event Insights

2,109 reports name Diphenhydramine Hcl; 300 recorded a death outcome (14.2% of reported events, not a population-level mortality rate). Active ingredient: Diphenhydramine Hcl. Administration routes: Unknown, Oral, Intramuscular, Intravenous.

By species: Dog (1,960 reports), Cat (146 reports), Horse (2 reports). By breed: Retriever - Labrador (181), Terrier - Bull - American Pit (158), Chihuahua (115).

Leading clinical signs: Vomiting (827), Lethargy (see also Central nervous system depression in 'Neurological') (594), Facial swelling (see also 'Skin') (323), Anaphylaxis (302). Outcome, 2,112 coded reports: Ongoing leads at 55.8%.

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.