Drug profile

The FDA adverse-event record for Diphenhydramine

2,668 adverse-event reports submitted to the FDA Center for Veterinary Medicine reference Diphenhydramine. See the species affected, top reactions, and outcomes below.

2,668
adverse-event reports
7.9%
death-coded share
Dog
most-reported species
582
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.
2,668
Total Reports
211
Deaths Reported
7.9%
Death Rate

Active Ingredients

Diphenhydramine

Administration Routes

UnknownOralIntramuscularParenteralSubcutaneousIntravenousTopicalOtherNasalTransdermal

Species Affected

Dog 2,475
Cat 176
Human 14
Unknown 1
Horse 1
Ferret 1

Most Affected Breeds

Retriever - Labrador 245
Crossbred Canine/dog 129
Chihuahua 113
Domestic Shorthair 111
Pit Bull 105
Boxer (German Boxer) 100
Terrier - Yorkshire 90
Shih Tzu 84
Pug 79
Bulldog - French 77

Most Reported Reactions

Vomiting 582
Emesis 339
Lethargy (see also Central nervous system depression in 'Neurological') 332
Diarrhoea 322
Lethargy (see also Central nervous system depression in Neurological) 228
Not eating 184
Lack of efficacy - NOS 183
Injection site swelling 178
Panting 155
Lack of efficacy (ectoparasite) - flea 153
Decreased appetite 148
Anaphylaxis 145

Outcome Breakdown

Recovered/Normal
1,002 (37.6%)
Outcome Unknown
794 (29.8%)
Ongoing
562 (21.1%)
Died
106 (4.0%)
Euthanized
105 (3.9%)
Recovered with Sequela
97 (3.6%)

Diphenhydramine Adverse Event Insights

2,668 reports name Diphenhydramine; 211 recorded a death outcome (7.9% of reported events, not a population-level mortality rate). Active ingredient: Diphenhydramine. Administration routes: Unknown, Oral, Intramuscular, Parenteral.

By species: Dog (2,475 reports), Cat (176 reports), Human (14 reports). By breed: Retriever - Labrador (245), Crossbred Canine/dog (129), Chihuahua (113).

Leading clinical signs: Vomiting (582), Emesis (339), Lethargy (see also Central nervous system depression in 'Neurological') (332), Diarrhoea (322). Outcome, 2,666 coded reports: Recovered/Normal leads at 37.6%.

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.