Drug profile

The FDA adverse-event record for Cetirizine

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

405
adverse-event reports
4.2%
death-coded share
Dog
most-reported species
77
Emesis - 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.
405
Total Reports
17
Deaths Reported
4.2%
Death Rate

Active Ingredients

Cetirizine

Administration Routes

OralUnknownTopicalAuricular (Otic)Ophthalmic

Species Affected

Dog 358
Cat 28
Human 19

Most Affected Breeds

Retriever - Labrador 40
Shih Tzu 23
Unknown 19
Retriever - Golden 18
Domestic Shorthair 16
Crossbred Canine/dog 15
Pit Bull 13
Maltese 11
Chihuahua 11
Terrier - Yorkshire 11

Most Reported Reactions

Emesis 77
Vomiting 58
Diarrhoea 57
Lethargy (see also Central nervous system depression in 'Neurological') 50
Lack of efficacy - NOS 46
Other abnormal test result NOS 25
Anorexia 22
Decreased appetite 20
Behavioural disorder NOS 19
Pruritus 19
Lethargy (see also Central nervous system depression in Neurological) 19
Lack of efficacy (ectoparasite) - flea 18

Outcome Breakdown

Recovered/Normal
175 (43.2%)
Outcome Unknown
113 (27.9%)
Ongoing
86 (21.2%)
Recovered with Sequela
14 (3.5%)
Euthanized
12 (3.0%)
Died
5 (1.2%)

Cetirizine Adverse Event Insights

405 reports name Cetirizine; 17 recorded a death outcome (4.2% of reported events, not a population-level mortality rate). Active ingredient: Cetirizine. Administration routes: Oral, Unknown, Topical, Auricular (Otic).

By species: Dog (358 reports), Cat (28 reports), Human (19 reports). By breed: Retriever - Labrador (40), Shih Tzu (23), Unknown (19).

Leading clinical signs: Emesis (77), Vomiting (58), Diarrhoea (57), Lethargy (see also Central nervous system depression in 'Neurological') (50). Outcome, 405 coded reports: Recovered/Normal leads at 43.2%.

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.