Cetirizine vs Hydroxyzine: side effects in FDA adverse event reports
At a glance
| Cetirizine | Hydroxyzine | |
|---|---|---|
| Drug class | – | – |
| Brand names | Cetirizine Hydrochloride | Hydroxyzine Hydrochloride |
| FAERS reports | 163,560 | 47,369 |
| Serious | 55% | 66% |
| Death outcome | 10,788 | 6,790 |
| Boxed warning | No | No |
Signals both drugs share
No strong shared signal after removing coding and lab terms.
Labeled signals distinctive to Cetirizine
- Glossodynia — n=8,134, PRR 73.1 Labeled (related wording)
- Muscle injury — n=3,851, PRR 113.5 Labeled (related wording)
Labeled signals distinctive to Hydroxyzine
- Anticholinergic syndrome — n=93, PRR 27.4 Labeled (related wording)
Common questions
Which has more reported side effects, Cetirizine or Hydroxyzine?
Cetirizine has 163,560 FAERS reports and Hydroxyzine 47,369. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (55% vs 66%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Cetirizine and Hydroxyzine share?
They share no strong flagged signal after artifacts and lab terms are removed.
Is Cetirizine or Hydroxyzine safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.