Drug profile

The FDA adverse-event record for Cetirizine

433 FDA reports name Cetirizine, a high-volume drug in the CVM extract. Species, reactions, and outcomes follow.

#338 of 2,679
by report volume (all drugs)
433
adverse-event reports
3.9%
death-coded share
Dog
most-reported species

Corpus placement

According to the FDA Center for Veterinary Medicine openFDA adverse-event extract, Cetirizine ranks #337 of 2679 by total reports (433) and #852 of 1130 by death-coded share (3.9%). 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)
#337
This drug, reports of 2679
#852
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. Cetirizine has 433 reports now versus 425 in that prior snapshot: 8 more (1.9%).

Report change
+8
Death-coded reports
+0
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 Cetirizine changes

Signature read: 433 reports place Cetirizine in the upper third of FDA AER volume (#338 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.
433
Total Reports
17
Deaths Reported
3.9%
Death-coded share of reports

Active Ingredients

Cetirizine

Administration Routes

OralUnknownTopicalAuricular (Otic)Ophthalmic

Species Affected

Dog 380
Cat 33
Human 20

Most Affected Breeds

Retriever - Labrador 43
Shih Tzu 25
Retriever - Golden 21
Unknown 20
Domestic Shorthair 18
Crossbred Canine/dog 15
Pit Bull 13
Chihuahua 12
Maltese 11
Bulldog - French 11

Most Reported Reactions

Emesis 77
Vomiting 64
Diarrhoea 61
Lethargy (see also Central nervous system depression in 'Neurological') 50
Lack of efficacy - NOS 49
Other abnormal test result NOS 25
Anorexia 23
Lethargy (see also Central nervous system depression in Neurological) 23
Decreased appetite 21
Behavioural disorder NOS 20
Pruritus 19
Lack of efficacy (ectoparasite) - flea 18

Outcome Breakdown

Recovered/Normal
181 (41.8%)
Outcome Unknown
122 (28.2%)
Ongoing
99 (22.9%)
Recovered with Sequela
14 (3.2%)
Euthanized
12 (2.8%)
Died
5 (1.2%)

Cetirizine: low death-coded share 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 Cetirizine, 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 Cetirizine (#338 of 2,679 by report volume); death-coded 3.9%. PlainBreed drug row · report volume stamp 433 · 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 →