Pet Recall Facts

Ingredients / Diphenhydramine

Diphenhydramine: FDA adverse event reports for pets

Reports received through June 26, 2026. Data and limitations.

4,982Total reports
4,608Dog reports
351Cat reports

FDA-approved products with this ingredient (Green Book)

No matching Green Book entry is supplied in this dataset. This alone does not establish regulatory status.

No Green Book record matches this ingredient name. It may be a human medicine used by veterinarians, a compounded product, a supplement or a product regulated by another agency; this alone does not establish regulatory status.

Brand names come only from the Green Book. Brand names in FDA's public report data are masked, so counts cannot be attributed to any brand. Ingredient names in the reports are written many ways; we group them under one ingredient name and count each report once per ingredient (method).

Reports by year received

19992
20013
20031
20041
20084
201136
2012364
2013468
2014212
2015312
2016421
2017358
2018322
2019336
2020372
2021293
2022195
2023295
2024352
2025432
2026203

Species named in reports

Dog4,608
Cat351
Human16
Ferret3
Horse3
Not given1

Signs reported after Diphenhydramine

Vomiting1,454
Lethargy (see also Central nervous system depression in Neurological)1,199
Diarrhoea642
Facial swelling (see also Skin)487
Anaphylaxis460
Hives (see also Skin)438
Emesis432
Anorexia331
Lack of efficacy - NOS320
Other abnormal test result NOS316
Not eating303
Pale mucous membrane302
Panting294
Fever281
Elevated alanine aminotransferase (ALT)262
Decreased appetite261
Death261
Death by euthanasia258
Pruritus246
Behavioural disorder NOS234
Injection site swelling225
Erythema (for urticaria see Immune SOC)195
Emesis (multiple)191
Pain NOS190
Bloody diarrhoea188

Breeds named in reports

Dog (unknown)525
Retriever - Labrador472
Chihuahua250
Terrier - Bull - American Pit246
Domestic Shorthair239
Crossbred Canine/dog205
Boxer (German Boxer)200
Terrier - Yorkshire198
Shih Tzu166
Pug150
Retriever - Golden145
Bulldog - French144
Poodle (unspecified)135
Dachshund (unspecified)131
Terrier (unspecified)127

Reported outcomes

Ongoing1,829
Recovered/Normal1,568
Outcome Unknown951
Died275
Euthanized259
Recovered with Sequela95

Report a problem to FDA