Drug profile

The FDA adverse-event record for Diphenhydramine

2,892 FDA reports name Diphenhydramine, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#77 of 2,679
by report volume (all drugs)
2,892
adverse-event reports
8.2%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Diphenhydramine ranks #77 of 2679 by total reports (2,892) and #632 of 1130 by death-coded share (8.2%). National dual: Milbemycin Oxime + Spinosad is #1 of 2679 drugs by total adverse-event reports (149,624) at death-coded-share rank 965 of 1130 drugs with at least 50 reports (2.3%); separately, Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) is #1 highest death-coded share at 97.8% (report rank #821).

149,624
Milbemycin Oxime + Spinosad reports (#1)
97.8%
Atlantic Salmon Transgenic Whole (Opafp-Ghc2 Rdna Construct Inserted Into The A-Locus In The Eo-1A Lineage) death share (#1)
#77
This drug, reports of 2679
#632
This drug, death share of 1130

Report volume reflects how common a breed or drug is and how often owners and vets file — not actual risk. Death-coded share ranks are limited to entries with enough reports to be meaningful. The two maps do not agree at #1.

Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Diphenhydramine has 2,892 reports now versus 2,797 in that prior snapshot: 95 more (3.4%).

Report change
+95
Death-coded reports
+11
Death-coded share
+0.1 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Diphenhydramine changes

Signature read: 2,892 reports place Diphenhydramine in the upper third of FDA AER volume (#77 of 2,679).

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
2,892
Total Reports
237
Deaths Reported
8.2%
Death-coded share of reports

Active Ingredients

Diphenhydramine

Administration Routes

UnknownOralIntramuscularParenteralSubcutaneousIntravenousOtherTopicalAuricular (Otic)Nasal

Species Affected

Dog 2,668
Cat 205
Human 16
Unknown 1
Horse 1
Ferret 1

Most Affected Breeds

Retriever - Labrador 260
Crossbred Canine/dog 136
Domestic Shorthair 135
Chihuahua 124
Pit Bull 109
Boxer (German Boxer) 105
Terrier - Yorkshire 94
Bulldog - French 93
Shih Tzu 90
Pug 88

Most Reported Reactions

Vomiting 642
Diarrhoea 353
Emesis 343
Lethargy (see also Central nervous system depression in 'Neurological') 332
Lethargy (see also Central nervous system depression in Neurological) 296
Not eating 212
Lack of efficacy - NOS 196
Injection site swelling 189
Panting 173
Anaphylaxis 171
Decreased appetite 170
Emesis (multiple) 163

Outcome Breakdown

Recovered/Normal
1,055 (36.5%)
Outcome Unknown
843 (29.2%)
Ongoing
658 (22.8%)
Euthanized
119 (4.1%)
Died
118 (4.1%)
Recovered with Sequela
97 (3.4%)

Diphenhydramine: high report volume in the FDA AER row

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.

High-volume nationwide drug peers

Two openFDA-derived peer sets for Diphenhydramine, both floored at ≥50 reports so the neighborhoods stay in the advertised mass.

What to do with this drug

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

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

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Diphenhydramine (#77 of 2,679 by report volume); death-coded 8.2%. PlainBreed drug row · report volume stamp 2,892 · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →